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If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L, 20‑400 mg/dL)

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (1.07 µmol/L, 3 mg/dL)

Limit of Detection

= 0.2 g/L (7.14 µmol/L, 20 mg/dL)

Limit of Quantitation

= 0.4 g/L (14.3 µmol/L, 40 mg/dL)

The Limit of Blank, the Limit of Detection and the Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration apolipoprotein A‑1 samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

The following values were obtained using serum from healthy subjects:

g/L

Men

1.04‑2.02 g/L

Women

1.08‑2.25 g/L

µmol/L*

Men

37.1‑72.1 µmol/L

Women

38.6‑80.3 µmol/L

mg/dL*

Men

104‑202 mg/dL

Women

108‑225 mg/dL

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A-1 level of 1.00 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet. For further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105448190

Tina-quant Apolipoprotein A-1 ver.2 (250 tests)

System‑ID 2019 001

cobas c 303,cobas c 503

12172623160

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 20424

05947626160

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 20190

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

80 µL

R3

20 µL

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

5 µL

100 µL

Decreased

2.4 µL

5 µL

100 µL

Increased

2.4 µL

5 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. Lipids

Calibration mode

Non-linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1a)

1.09 (109)

0.0210 (2.10)

1.9

PCCC2b)

1.39 (139)

0.0158 (1.58)

1.1

Human serum 1

0.370 (37.0)

0.0109 (1.09)

2.9

Human serum 2

0.950 (95.0)

0.0129 (1.29)

1.4

Human serum 3

1.74 (174)

0.0154 (1.54)

0.9

Human serum 4

1.95 (195)

0.0255 (2.55)

1.3

Human serum 5

3.45 (345)

0.0198 (1.98)

0.6

Intermediate precision

Mean
g/L (mg/dL)

SD
g/L (mg/dL)

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.09 (109)

0.0266 (2.66)

2.4

PCCC2

FREFPreciControl ClinChem Multi 2

1.39 (139)

0.0345 (3.45)

2.5

Human serum 1

0.363 (36.3)

0.0222 (2.22)

6.1

Human serum 2

0.955 (95.5)

0.0235 (2.35)

2.5

Human serum 3

1.69 (169)

0.0303 (3.03)

1.8

Human serum 4

1.95 (195)

0.0334 (3.34)

1.7

Human serum 5

3.45 (345)

0.0385 (3.85)

1.1

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 101

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.966x + 0.0687 g/L

y = 0.961x + 0.0785 g/L

τ = 0.968

r = 0.999

The sample concentrations were between 0.362 and 3.93 g/L (36.2 and 393 mg/dL).

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 108

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.958x + 0.103 g/L

y = 0.958x + 0.104 g/L

τ = 0.953

r = 0.997

The sample concentrations were between 0.209 and 3.96 g/L (20.9 and 396 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin‑cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo‑α‑lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B, and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (−15)‑(−25) °C

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.
(only freeze once)

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105448190c503", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000028C2B0E", "DocumentOriginID": "FF0000000289CD0E", "MaterialNumbers": [ "08105448190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L)

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (1.07 µmol/L)

Limit of Detection

= 0.2 g/L (7.14 µmol/L)

Limit of Quantitation

= 0.4 g/L (14.3 µmol/L)

The Limit of Blank, the Limit of Detection and the Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration apolipoprotein A‑1 samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

The following values were obtained using serum from healthy subjects:

g/L

Men

1.04‑2.02 g/L

Women

1.08‑2.25 g/L

µmol/L*

Men

37.1‑72.1 µmol/L

Women

38.6‑80.3 µmol/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105448 190

Tina-quant Apolipoprotein A-1 ver.2 (250 tests)

System‑ID 2019 001

Roche/Hitachi cobas c 503

12172623 122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 20424

12172623 160

Calibrator f.a.s. Lipids (3 x 1 mL, for USA)

Code 20424

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 20190

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

80 µL

R3

20 µL

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

5 µL

100 µL

Decreased

2.4 µL

5 µL

100 µL

Increased

2.4 µL

5 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. Lipids

Calibration mode

Non-linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Repeatability

Mean
g/L

SD
g/L

CV
%

PCCC1a)

1.09

0.0210

1.9

PCCC2b)

1.39

0.0158

1.1

Human serum 1

0.370

0.0109

2.9

Human serum 2

0.950

0.0129

1.4

Human serum 3

1.74

0.0154

0.9

Human serum 4

1.95

0.0255

1.3

Human serum 5

3.45

0.0198

0.6

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi1

1.09

0.0266

2.4

PCCC2

FREFPreciControl ClinChem Multi2

1.39

0.0345

2.5

Human serum 1

0.363

0.0222

6.1

Human serum 2

0.955

0.0235

2.5

Human serum 3

1.69

0.0303

1.8

Human serum 4

1.95

0.0334

1.7

Human serum 5

3.45

0.0385

1.1

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 101

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.966x + 0.0687 g/L

y = 0.961x + 0.0785 g/L

τ = 0.968

r = 0.999

The sample concentrations were between 0.362 and 3.93 g/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin‑cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo‑α‑lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B, and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (−15)‑(−25) °C

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.
(only freeze once)

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105448190c503", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000046BE60E", "DocumentOriginID": "FF000000028C2B0E", "MaterialNumbers": [ "08105448190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L)

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (1.07 µmol/L)

Limit of Detection

= 0.2 g/L (7.14 µmol/L)

Limit of Quantitation

= 0.4 g/L (14.3 µmol/L)

The Limit of Blank, the Limit of Detection and the Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration apolipoprotein A‑1 samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

The following values were obtained using serum from healthy subjects:

g/L

Men

1.04‑2.02 g/L

Women

1.08‑2.25 g/L

µmol/L*

Men

37.1‑72.1 µmol/L

Women

38.6‑80.3 µmol/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105448 190

Tina-quant Apolipoprotein A-1 ver.2 (250 tests)

System‑ID 2019 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

12172623 122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 20424

12172623 160

Calibrator f.a.s. Lipids (3 x 1 mL, for USA)

Code 20424

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 20190

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

80 µL

R3

20 µL

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

5 µL

100 µL

Decreased

2.4 µL

5 µL

100 µL

Increased

2.4 µL

5 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. Lipids

Calibration mode

Non-linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Repeatability

Mean
g/L

SD
g/L

CV
%

PCCC1a)

1.09

0.0210

1.9

PCCC2b)

1.39

0.0158

1.1

Human serum 1

0.370

0.0109

2.9

Human serum 2

0.950

0.0129

1.4

Human serum 3

1.74

0.0154

0.9

Human serum 4

1.95

0.0255

1.3

Human serum 5

3.45

0.0198

0.6

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.09

0.0266

2.4

PCCC2

FREFPreciControl ClinChem Multi 2

1.39

0.0345

2.5

Human serum 1

0.363

0.0222

6.1

Human serum 2

0.955

0.0235

2.5

Human serum 3

1.69

0.0303

1.8

Human serum 4

1.95

0.0334

1.7

Human serum 5

3.45

0.0385

1.1

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 101

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.966x + 0.0687 g/L

y = 0.961x + 0.0785 g/L

τ = 0.968

r = 0.999

The sample concentrations were between 0.362 and 3.93 g/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin‑cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo‑α‑lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B, and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (−15)‑(−25) °C

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.
(only freeze once)

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108105448190c503", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF000000049AEB0E", "DocumentOriginID": "FF0000000484BE0E", "MaterialNumbers": [ "08105448190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L)

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.03 g/L (1.07 µmol/L)

Limit of Detection

= 0.2 g/L (7.14 µmol/L)

Limit of Quantitation

= 0.4 g/L (14.3 µmol/L)

The Limit of Blank, the Limit of Detection and the Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration apolipoprotein A‑1 samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

The following values were obtained using serum from healthy subjects:

g/L

Men

1.04‑2.02 g/L

Women

1.08‑2.25 g/L

µmol/L*

Men

37.1‑72.1 µmol/L

Women

38.6‑80.3 µmol/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105448190

Tina-quant Apolipoprotein A-1 ver.2 (250 tests)

System‑ID 2019 001

cobas c 303, cobas c 503

Materials required (but not provided):

12172623122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 20424

05117003190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 20190

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

80 µL

R3

20 µL

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.4 µL

5 µL

100 µL

Decreased

2.4 µL

5 µL

100 µL

Increased

2.4 µL

5 µL

100 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. Lipids

Calibration mode

Non-linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
g/L

SD
g/L

CV
%

PCCC1a)

1.09

0.0210

1.9

PCCC2b)

1.39

0.0158

1.1

Human serum 1

0.370

0.0109

2.9

Human serum 2

0.950

0.0129

1.4

Human serum 3

1.74

0.0154

0.9

Human serum 4

1.95

0.0255

1.3

Human serum 5

3.45

0.0198

0.6

Intermediate precision

Mean
g/L

SD
g/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1.09

0.0266

2.4

PCCC2

FREFPreciControl ClinChem Multi 2

1.39

0.0345

2.5

Human serum 1

0.363

0.0222

6.1

Human serum 2

0.955

0.0235

2.5

Human serum 3

1.69

0.0303

1.8

Human serum 4

1.95

0.0334

1.7

Human serum 5

3.45

0.0385

1.1

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 101

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.966x + 0.0687 g/L

y = 0.961x + 0.0785 g/L

τ = 0.968

r = 0.999

The sample concentrations were between 0.362 and 3.93 g/L.

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 108

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.958x + 0.103 g/L

y = 0.958x + 0.104 g/L

τ = 0.953

r = 0.997

The sample concentrations were between 0.209 and 3.96 g/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin‑cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo‑α‑lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B, and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (−15)‑(−25) °C

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.
(only freeze once)

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005950686190c701", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF00000003566A0E", "DocumentOriginID": "FF0000000039AE0E", "MaterialNumbers": [ "05950686190", "05950686214" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L, 20‑400 mg/dL)

Lower limits of measurement

Lower detection limit of the test:

0.03 g/L (1.07 µmol/L, 3 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.03 g/L) will not be flagged by the instrument.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

The following values were obtained using serum from healthy subjects:

Men

1.04-2.02 g/L (37.1-72.1 µmol/L, 104-202 mg/dL)

Women

1.08-2.25 g/L (38.6-80.3 µmol/L, 108-225 mg/dL)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at apolipoprotein A‑1 levels of 1.00 g/L (35.7 µmol/L, 100 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L (393 µmol/L, 1100 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05950686 190*

Tina‑quant Apolipoprotein A‑1 ver.2 (100 tests)

System‑ID 01 6568 6

Roche/Hitachi cobas c 701/702

05950686 214*

Tina‑quant Apolipoprotein A‑1 ver.2 (100 tests)

System‑ID 01 6568 6

Roche/Hitachi cobas c 701/702

12172623 122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 424

12172623 160

Calibrator f.a.s. Lipids (3 x 1 mL, for USA)

Code 424

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

* Some kits shown may not be available in all countries.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 8168

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑29

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

25 µL

30 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

9 µL

180 µL

Decreased

3 µL

9 µL

180 µL

Increased

3 µL

9 µL

180 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

APOAT

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

2 weeks

On‑board on the Reagent Manager:

24 hours

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2‑S6: C.f.a.s. Lipids

Multiply the lot‑specific C.f.a.s. Lipids calibrator values by the factors below to determine the standard concentrations for the 6‑point calibration curve:

S2: 0.208

S5: 1.313

S3: 0.412

S6: 2.006

S4: 1.000

Calibration mode

RCM

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean g/L
(µmol/L, mg/dL)

SD g/L
(µmol/L, mg/dL)

CV
%

Precinorm L

1.46 (52.1, 146)

0.01 (0.4, 1)

1.0

Precipath L

0.836 (29.8, 83.6)

0.010 (0.4, 1.0)

1.2

Human serum A

0.978 (34.9, 97.8)

0.017 (0.6, 1.7)

1.8

Human serum B

1.88 (67.1, 188)

0.02 (0.7, 2)

1.2

Human serum C

3.48 (124, 348)

0.02 (1, 2)

0.7

Intermediate precision

Mean g/L
(µmol/L, mg/dL)

SD g/L
(µmol/L, mg/dL)

CV
%

Precinorm L

1.74 (62.1, 174)

0.08 (2.9, 8)

4.7

Precipath L

1.06 (37.8, 106)

0.04 (1.4, 4)

3.9

Human serum 3

1.17 (41.8, 117)

0.04 (1.4, 4)

3.6

Human serum 4

2.40 (85.7, 240)

0.03 (1.1, 3)

1.4

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 109

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.020x - 0.054 g/L

y = 1.017x - 0.052 g/L

τ = 0.960

r = 0.998

The sample concentrations were between 0.303 and 3.93 g/L (10.8 and 140 µmol/L, 30.3 and 393 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin-cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo-α-lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 weeks at (-15)‑(-25) °C
LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.

(only freeze once)

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005950686190c701", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "8", "DocumentObjectID": "FF000000046BE40E", "DocumentOriginID": "FF00000003566A0E", "MaterialNumbers": [ "05950686190", "05950686214" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L, 20‑400 mg/dL)

Lower limits of measurement

Lower detection limit of the test:

0.03 g/L (1.07 µmol/L, 3 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 0.03 g/L) will not be flagged by the instrument.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

The following values were obtained using serum from healthy subjects:

Men

1.04-2.02 g/L (37.1-72.1 µmol/L, 104-202 mg/dL)

Women

1.08-2.25 g/L (38.6-80.3 µmol/L, 108-225 mg/dL)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at apolipoprotein A‑1 levels of 1.00 g/L (35.7 µmol/L, 100 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L (393 µmol/L, 1100 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05950686 190*

Tina‑quant Apolipoprotein A‑1 ver.2 (100 tests)

System‑ID 01 6568 6

Roche/Hitachi cobas c 701/702

05950686 214*

Tina‑quant Apolipoprotein A‑1 ver.2 (100 tests)

System‑ID 01 6568 6

Roche/Hitachi cobas c 701/702

* Some kits shown may not be available in all countries.

Materials required (but not provided):

12172623 122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 424

12172623 160

Calibrator f.a.s. Lipids (3 x 1 mL, for USA)

Code 424

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

APOAT: ACN 8168

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 18‑29

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R3

25 µL

30 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

9 µL

180 µL

Decreased

3 µL

9 µL

180 µL

Increased

3 µL

9 µL

180 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

APOAT

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

2 weeks

On‑board on the Reagent Manager:

24 hours

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2‑S6: C.f.a.s. Lipids

Multiply the lot‑specific C.f.a.s. Lipids calibrator values by the factors below to determine the standard concentrations for the 6‑point calibration curve:

S2: 0.208

S5: 1.313

S3: 0.412

S6: 2.006

S4: 1.000

Calibration mode

RCM

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean g/L
(µmol/L, mg/dL)

SD g/L
(µmol/L, mg/dL)

CV
%

Precinorm L

1.46 (52.1, 146)

0.01 (0.4, 1)

1.0

Precipath L

0.836 (29.8, 83.6)

0.010 (0.4, 1.0)

1.2

Human serum A

0.978 (34.9, 97.8)

0.017 (0.6, 1.7)

1.8

Human serum B

1.88 (67.1, 188)

0.02 (0.7, 2)

1.2

Human serum C

3.48 (124, 348)

0.02 (1, 2)

0.7

Intermediate precision

Mean g/L
(µmol/L, mg/dL)

SD g/L
(µmol/L, mg/dL)

CV
%

Precinorm L

1.74 (62.1, 174)

0.08 (2.9, 8)

4.7

Precipath L

1.06 (37.8, 106)

0.04 (1.4, 4)

3.9

Human serum 3

1.17 (41.8, 117)

0.04 (1.4, 4)

3.6

Human serum 4

2.40 (85.7, 240)

0.03 (1.1, 3)

1.4

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 109

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.020x - 0.054 g/L

y = 1.017x - 0.052 g/L

τ = 0.960

r = 0.998

The sample concentrations were between 0.303 and 3.93 g/L (10.8 and 140 µmol/L, 30.3 and 393 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin-cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo-α-lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R3

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 weeks at (-15)‑(-25) °C
LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.

(only freeze once)

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0003032566122COIN", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF000000046BF10E", "DocumentOriginID": "FF00000000F3D20E", "MaterialNumbers": [ "03032566122" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative immunological determination of apolipoprotein A‑1 in human serum and plasma on COBAS INTEGRA systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay

Human apolipoprotein A‑1 forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.20‑4.0 g/L (7.14‑143 µmol/L or 20‑400 mg/dL) (typical measuring range)

The upper limit of the measuring range depends on the actual calibrator value.

Determine samples having lower concentrations via the rerun function. For samples with lower concentrations, the rerun function reduces the sample predilution factor to 10.5. The results are automatically multiplied by the reduced predilution factor.

Lower limits of measurement

Lower detection limit of the test:
0.2 g/L (7.14 µmol/L or 20 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

The following reference values were determined using serum from healthy adults:

Apolipoprotein A-1

Females
n = 150

1.08-2.25 g/L
(38.6-80.3 µmol/L or 108‑225 mg/dL)

Males
n = 150

1.04-2.02 g/L
(37.1-72.1 µmol/L or 104‑202 mg/dL)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug Effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on COBAS INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

Orderinformation_INT

Order information

Analyzer(s) on which cobas c pack(s) can be used

03032566 122

Tina-quant Apolipoprotein A-1 ver.2 (100 tests)

System-ID 07 6568 6

COBAS INTEGRA 400 plus

Materials required (but not provided):

12172623 122

Calibrator f.a.s. Lipids (3 × 1 mL)

System-ID 07 6570 8

12172623 160

Calibrator f.a.s. Lipids (3 × 1 mL, for USA)

System-ID 07 6570 8

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05947626 160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

System-ID 07 7469 3

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

05947774 160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

System-ID 07 7470 7

20756350 322

NaCl Diluent 9 % (6 × 22 mL)

System-ID 07 5635 0

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Test APOAT, test-ID 0-568

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Measuring mode

Absorbance

Abs. calculation mode

Endpoint

Reaction mode

D-R1-S-SR

Reaction direction

Increase

Wavelength A/B

340/659 nm

Calc. first/last

33/68

Typical prozone effect

> 6 g/L (> 214 µmol/L or > 600 mg/dL)

Antigen excess check

No

Predilution factor

21

Unit

g/L

Pipetting parameters

Diluent (H2O)

R1

100 µL

Sample

3 µL

20 µL

SR

25 µL

10 µL

Total volume

158 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C

See expiration date on cobas c pack label

On-board in use at 10‑15 °C

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

Calibrator f.a.s. Lipids

Calibration dilution ratio

1:10.5, 1:16, 1:21, 1:51, 1:101, NaCl 0.9 % is used as zero calibrator performed automatically by the instrument

Calibration mode

Logit/log 4

Calibration replicate

Duplicate recommended

Calibration interval

Each lot and as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Enter the assigned lot specific apolipoprotein A‑1 value of the undiluted calibrator, indicated in the package insert of the calibrator C.f.a.s. Lipids.

Traceability: This method has been standardized with regard to the IFCC reference preparation SP1‑01 (October 1992 WHO-IRP) for apolipoprotein A‑1 and the IFCC reference preparation SP3‑07 for apolipoprotein B.

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

Level 1

Level 2

Mean

0.88 g/L
(31.4 µmol/L or 88 mg/dL)

1.64 g/L
(58.5 µmol/L or 164 mg/dL)

CV repeatability

1.0 %

0.8 %

CV intermediate precision

2.4 %

1.7 %

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum samples obtained on a COBAS INTEGRA 400 analyzer with the COBAS INTEGRA Tina‑quant Apolipoprotein A‑1 ver.2 reagent (APOAT) (y) were compared with those determined on a COBAS INTEGRA 400 analyzer using the previous COBAS INTEGRA Apolipoprotein A‑1 reagent (APOA) (x), and with those obtained with the same reagent on a Roche/Hitachi 917 analyzer (x).

COBAS INTEGRA 400
analyzer

Roche/Hitachi 917
analyzer

Sample size

(n)

78

104

Corr. coefficient

(r)

0.940

0.999

Linear regression

y = 0.82x + 0.32 g/L

y = 0.97x + 0.05 g/L

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

y = 0.87x + 0.25 g/L

y = 0.96x + 0.05 g/L

The sample concentrations were between 0.10 and 3.05 g/L (3.57‑109 μmol/L or 10‑305 mg/dL).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high-density lipoproteins (HDL). HDL are synthesized by the intestines and the liver; they transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin-cholesterol acyltransferase (LCAT), which catalyzes the esterification of cholesterol enhancing the lipid carrying capacity of the lipoproteins. Apolipoprotein A‑1 levels increase in pregnancy, liver disease, and as a result of estrogen administration (e.g. contraceptive pills). Apolipoprotein A‑1 levels decrease in inherited hypo-α-lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis, and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL). These particles mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL particles with a high proportion of cholesterol are formed. Apolipoprotein B is the major constituent of LDL.

The combined determination of apolipoprotein A‑1 and apolipoprotein B and the calculation of the apolipoprotein B/apolipoprotein A‑1 ratio can reflect a disorder of lipid metabolism and the risk of developing atherosclerosis and coronary heart disease particularly well providing an excellent addition to the classical HDL/LDL cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; polyethylene glycol: 3.8 %; detergent; preservative.

SR

Anti-human apolipoprotein A-1 antibody (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative.

R1 is in position B and SR is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Reference range

PreciControl ClinChem Multi 1

Pathological range

PreciControl ClinChem Multi 2

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable:
Serum
Plasma: Heparin (Li-, Na-, NH4+-) or EDTA (Na2-, K2-, K3-) plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Samples and controls are automatically prediluted 1:21 (1+20) with NaCl solution by the instrument.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

1 day at 15-25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2-8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (−15)-(−20) °C (freeze only once)

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0003032566122c501", "ProductName": "APOAT", "ProductLongName": "Tina-quant Apolipoprotein A-1 ver.2", "Language": "en", "DocumentVersion": "12", "DocumentObjectID": "FF000000046BFA0E", "DocumentOriginID": "FF000000006F970E", "MaterialNumbers": [ "03032566122" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFBecker W, Rapp W, Schwick HG, et al. Methoden zur quantitativen Bestimmung von Plasmaproteinen durch Immunpräzipitation. Z Klin Chem Klin Biochem. 1968;6:113-122.
,
LREFSiedel J, Schiefer S, Rosseneu M, et al. Immunoturbidimetric Method for Routine Determinations of Apolipoproteins A-I, A-II and B in Normo- and Hyperlipemic Sera compared with Immunonephelometry. Clin Chem. 1988;34(9):1821-1825.
,
LREFRifai N, King ME. Immunoturbidimetric Assays of Apolipoproteins A, AI, AII and B in serum. Clin Chem. 1986;32:957-961.
,
LREFNaito HK. Reliability of Lipid, Lipoprotein and Apolipoprotein Measurements. Clin Chem. 1988;34:B84-B94.

Immunoturbidimetric assay.

Anti‑apolipoprotein A‑1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, can be measured turbidimetrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

0.2‑4.0 g/L (7.14‑143 µmol/L, 20‑400 mg/dL)

Lower limits of measurement

Lower detection limit of the test

0.03 g/L (1.07 µmol/L, 3 mg/dL)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values

The following values were obtained using serum from healthy subjects:

Men

1.04‑2.02 g/L (37.1‑72.1 µmol/L, 104‑202 mg/dL)

Women

1.08‑2.25 g/L (38.6‑80.3 µmol/L, 108‑225 mg/dL)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at apolipoprotein A‑1 levels of 1.00 g/L (35.7 µmol/L, 100 mg/dL).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL or 1026 µmol/L).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 1200 IU/mL.

High dose hook‑effect: No false result occurs up to an apolipoprotein A‑1 concentration of 11 g/L (392 µmol/L, 1100 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

03032566 122

Tina-quant Apolipoprotein A-1 ver.2 100 tests

System‑ID 07 6568 6

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

12172623 122

Calibrator f.a.s. Lipids (3 x 1 mL)

Code 424

12172623 160

Calibrator f.a.s. Lipids (3 x 1 mL, for USA)

Code 424

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

04489357 190

Diluent NaCl 9 % (50 mL)

System‑ID 07 6869 3

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

APOAT: ACN 168

For cobas c 502 analyzer:

APOAT: ACN 8168

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 311 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 6‑19

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

25 µL

30 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

9 µL

180 µL

Decreased

3 µL

9 µL

180 µL

Increased

3 µL

9 µL

180 µL

cobas c 501/502 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 10‑28

Wavelength (sub/main)

700/340 nm

Reaction direction

Increase

Units

g/L (µmol/L, mg/dL)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2

25 µL

30 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

9 µL

180 µL

Decreased

3 µL

9 µL

180 µL

Increased

3 µL

9 µL

180 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

APOAT

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2‑S6: C.f.a.s. Lipids

Multiply the lot‑specific C.f.a.s. Lipids calibrator values by the factors below to determine the standard concentrations for the 6‑point calibration curve:

S2: 0.208

S5: 1.313

S3: 0.412

S6: 2.006

S4: 1.000

Calibration mode

RCM

Calibration frequency

Full calibration
• after reagent lot change
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the IFCC SP1‑01 reference standard (WHO‑IRP October 1992).

LREFMarcovina SM, Albers JJ, Dati F, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. Clin Chem. 1991;37:1676-1682.
,
LREFAlbers JJ, Marcovina SM, Kennedy H. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. II. Evaluation and Selection of Candidate Reference Materials. Clin Chem. 1992;38:658-662.
,
LREFMarcovina SM, Albers JJ, Henderson LO, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. III. Comparability of Apolipoprotein A-I Values by Use of International Reference Material. Clin Chem. 1993;39:773-781.
,
LREFMarcovina SM, Albers JJ, Kennedy H, et al. International Federation of Clinical Chemistry Standardization Project for Measurements of Apolipoproteins A-I and B. IV. Comparability of Apolipoprotein B Values by Use of International Reference Material. Clin Chem. 1994;40:586-592.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm L

1.60 (57.1, 160)

0.02 (0.7, 2)

1.1

Precipath L

1.00 (35.7, 100)

0.01 (0.4, 1)

1.5

Human serum 1

0.99 (35.3, 99.0)

0.02 (0.7, 2)

1.5

Human serum 2

2.59 (92.5, 259)

0.02 (0.7, 2)

1.0

Intermediate precision

Mean

g/L (µmol/L, mg/dL)

SD

g/L (µmol/L, mg/dL)

CV

%

Precinorm L

1.74 (62.1, 174)

0.08 (2.9, 8)

4.7

Precipath L

1.06 (37.8, 106)

0.04 (1.4, 4)

3.9

Human serum 3

1.17 (41.8, 117)

0.04 (1.4, 4)

3.6

Human serum 4

2.40 (85.7, 240)

0.03 (1.1, 3)

1.4

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Apolipoprotein A‑1 values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 126

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.014x + 0.073 g/L

y = 1.006x + 0.087 g/L

τ = 0.949

r = 0.996

The sample concentrations were between 0.380 and 3.34 g/L (13.6 and 119 µmol/L, 38.0 and 334 mg/dL).

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFRiesen WF. Apolipoproteine. In: Thomas L, ed. Labor und Diagnose, 5th ed. Frankfurt 1998;171-190.
,
LREFBrewer HB Jr, Gregg RE, Hoeg JM, et al. Apolipoproteins and lipoproteins in human plasma: an overview. Clin Chem. 1988;34:B4-B8.

Apolipoproteins are the protein constituents of the lipoproteins. The lipoproteins are classified according to their ultracentrifugal flotation density. Apolipoprotein A‑1 is the major protein constituent of high‑density lipoproteins (HDL). HDL are synthesized by the intestines and the liver. They transport excess cellular cholesterol from extrahepatic tissue and peripheral cells to the liver. Additionally, apolipoprotein A‑1 activates the enzyme lecithin‑cholesterol‑acyltransferase (LCAT), which catalyzes the esterification of cholesterol, thereby enhancing the lipid‑carrying capacity of the lipoproteins.

Apolipoprotein A‑1 levels increase in liver disease, pregnancy and as a result of estrogen administration (e.g. oral contraceptives). Apolipoprotein A‑1 levels decrease in inherited hypo‑α‑lipoproteinemia (e.g. Tangier disease), cholestasis, sepsis and atherosclerosis. The liver also synthesizes very low density lipoproteins (VLDL) which mainly contain triglycerides and cholesterol. In the presence of lipoprotein lipase the triglycerides are hydrolyzed and LDL‑particles with a high proportion of cholesterol are formed. Apolipoprotein B is the main constituent of LDL.

The combined determination of apolipoprotein A‑1/apolipoprotein B and the calculation of the apolipoprotein B : apolipoprotein A‑1 ratio can reflect a lipid metabolism disorder and the risk of developing atherosclerosis or coronary heart disease particularly well, thus providing an excellent addition to the classical HDL/LDL‑cholesterol determination. A high level of apolipoprotein A‑1 (HDL) and a low level of apolipoprotein B (LDL) correlate best with a low risk for these diseases.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

TRIS buffer: 50 mmol/L, pH 8.0; PEG: 3.8 %; detergent; preservative

R2

Anti‑human apolipoprotein A‑1 antibodies (sheep): dependent on titer; TRIS buffer: 100 mmol/L, pH 8.0; preservative

R1 is in position B, and R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability:

1 day at 15‑25 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

8 days at 2‑8 °C

LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

2 months at (-15)‑(-25) °C

LREFEvans K, Mitcheson J, Laker M. Effect of Storage at 4 °C and -20 °C on Lipid, Lipoprotein, and Apolipoprotein Concentrations. Clin Chem. 1995;41:392-396.
(only freeze once)

", "Language": "en" } ] } } ] }

APOAT

Tina-quant Apolipoprotein A-1 ver.2

IVD For in vitro diagnostic use.
APOAT

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

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