In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
0.2‑4.0 g/L (7.14‑143 µmol/L, 20‑400 mg/dL)
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.
The following values were obtained using serum from healthy subjects:
Men | 1.04‑2.02 g/L |
Women | 1.08‑2.25 g/L |
Men | 37.1‑72.1 µmol/L |
Women | 38.6‑80.3 µmol/L |
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.
Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A-1 level of 1.00 g/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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
|
| 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 | |
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 |
APOAT: ACN 20190
Ready for use
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.
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 |
Calibrators | S1: H2O S2‑S6: C.f.a.s. Lipids |
Calibration mode | Non-linear |
Calibration frequency | Full calibration |
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).
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.
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).
Repeatability | Mean | SD | 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 | SD | 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 |
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).
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).
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).
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.
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.
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.
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.
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.
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
0.2‑4.0 g/L (7.14‑143 µmol/L)
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.
The following values were obtained using serum from healthy subjects:
Men | 1.04‑2.02 g/L |
Women | 1.08‑2.25 g/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.
Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
APOAT: ACN 20190
Ready for use
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.
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 |
Calibrators | S1: H2O S2‑S6: C.f.a.s. Lipids |
Calibration mode | Non-linear |
Calibration frequency | Full calibration |
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).
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.
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 | SD | 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 | SD | 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 |
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).
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.
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.
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.
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.
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.
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.
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
0.2‑4.0 g/L (7.14‑143 µmol/L)
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.
The following values were obtained using serum from healthy subjects:
Men | 1.04‑2.02 g/L |
Women | 1.08‑2.25 g/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.
Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
APOAT: ACN 20190
Ready for use
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.
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 |
Calibrators | S1: H2O S2‑S6: C.f.a.s. Lipids |
Calibration mode | Non-linear |
Calibration frequency | Full calibration |
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).
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.
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 | SD | 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 | SD | 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 |
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).
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.
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.
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.
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.
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.
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.
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
0.2‑4.0 g/L (7.14‑143 µmol/L)
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.
The following values were obtained using serum from healthy subjects:
Men | 1.04‑2.02 g/L |
Women | 1.08‑2.25 g/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.
Criterion: Recovery within ± 10 % of initial values at an apolipoprotein A‑1 level of 1.00 g/L.
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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
|
| 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 |
APOAT: ACN 20190
Ready for use
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.
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 |
Calibrators | S1: H2O S2‑S6: C.f.a.s. Lipids |
Calibration mode | Non-linear |
Calibration frequency | Full calibration |
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).
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.
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).
Repeatability | Mean | SD | 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 | SD | 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 |
Apolipoprotein A‑1 values for human serum and plasma samples obtained on
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).
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.
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.
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.
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 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.
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.
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
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.
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.
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:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
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 |
APOAT: ACN 8168
Ready for use
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 |
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 |
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 |
Calibrators | S1: H2O | |
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 |
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).
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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 | SD g/L | 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 | SD g/L | 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.
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). |
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.
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.
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.
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.
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) |
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
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.
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.
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:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
APOAT: ACN 8168
Ready for use
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 |
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 |
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 |
Calibrators | S1: H2O | |
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 |
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).
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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 | SD g/L | 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 | SD g/L | 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.
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). |
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.
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.
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.
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.
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) |
In vitro test for the quantitative immunological determination of apolipoprotein A‑1 in human serum and plasma on COBAS INTEGRA systems.
Immunoturbidimetric assay
Human apolipoprotein A‑1 forms a precipitate with a specific antiserum which is determined turbidimetrically at 340 nm.
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 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).
The following reference values were determined using serum from healthy adults:
Females | 1.08-2.25 g/L |
Males | 1.04-2.02 g/L |
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value.
Icterus:
Hemolysis:
Lipemia (Intralipid):
Rheumatoid factors: No significant interference.
Drugs: No interference was found at therapeutic concentrations using common drug panels.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
Test APOAT, test-ID 0-568
Ready for use
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 |
Diluent (H2O) | ||
R1 | 100 µL | |
Sample | 3 µL | 20 µL |
SR | 25 µL | 10 µL |
Total volume | 158 µL |
Shelf life at 2‑8 °C | See expiration date on cobas c pack label |
On-board in use at 10‑15 °C | 12 weeks |
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.
Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.
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 | 1.64 g/L |
CV repeatability | 1.0 % | 0.8 % |
CV intermediate precision | 2.4 % | 1.7 % |
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 | Roche/Hitachi 917 | ||
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).
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.
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.
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.
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.
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.
In vitro test for the quantitative determination of Apolipoprotein A‑1 in human serum and plasma on Roche/Hitachi cobas c systems.
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.
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).
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.
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:
Hemolysis:
Lipemia (Intralipid):
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.
In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.
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.
|
| 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 |
For cobas c 311/501 analyzers:
APOAT: ACN 168
For cobas c 502 analyzer:
APOAT: ACN 8168
Ready for use
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 |
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 |
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 |
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).
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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 |
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). |
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.
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.
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.
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.
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) |
Tina-quant Apolipoprotein A-1 ver.2
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