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Intended use

In vitro test for the quantitative determination of alanine aminotransferase (ALT) with pyridoxal phosphate activation in human serum and plasma on cobas c systems.

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

Test principle

This assay follows the recommendations of the IFCC, but was optimized for performance and stability.

LREFBergmeyer HU, Hørder M, Rej R. Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes. Part 3. IFCC method for alanine aminotransferase. J Clin Chem Clin Biochem 1986;24:481-495.
,
LREFECCLS. Determination of the catalytic activity concentration in serum of L-alanine aminotransferase (EC 2.6.1.2, ALAT). Klin Chem Mitt 1989;20:204-211.

ALT catalyzes the reaction between L‑alanine and 2‑oxoglutarate. The pyruvate formed is reduced by NADH in a reaction catalyzed by lactate dehydrogenase (LDH) to form L‑lactate and NAD+ . Pyridoxal phosphate serves as a coenzyme in the amino transfer reaction. It ensures full enzyme activation.

L‑Alanine + 2‑oxoglutarate

ALT

pyruvate + L‑glutamate

Pyruvate + NADH + H+

LDH

L‑lactate + NAD+

The rate of the NADH oxidation is directly proportional to the catalytic ALT activity. It is determined by measuring the decrease in absorbance.

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

Limits and ranges

Measuring range

5‑700 U/L (0.08‑11.7 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 5 U/L (0.08 µkat/L)

Limit of Detection

= 5 U/L (0.08 µkat/L)

Limit of Quantitation

= 6 U/L (0.10 µkat/L)

The Limit of Blank, Limit of Detection and 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 activity 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 activity samples.

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

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity alanine aminotransferase samples.

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

Expected values

U/L*

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

10‑50 U/L

Females

10‑35 U/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 50 U/L

Females

up to 35 U/L

*calculated by unit conversion factor

µkat/L

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

0.17‑0.83 µkat/L

Females

0.17‑0.58 µkat/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 0.83 µkat/L

Females

up to 0.58 µkat/L

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 an ALT activity of 35 U/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: 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 170 (approximate hemoglobin concentration: 106 µmol/L or 170 mg/dL).
Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

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 150. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.
Lipemic samples may cause > Abs flagging.

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.
Exception: Calcium dobesilate can cause artificially low ALT results at therapeutic concentrations.

Cyanokit (Hydroxocobalamin) may cause interference with results.

Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results.

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

08056773190

Alanine Aminotransferase acc. to IFCC (450 tests)

System‑ID 2013 001

cobas c 303, cobas c 503

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

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

09119922191

Pyridoxal phosphate (950 tests)

System‑ID 2012 002

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

System information

ALTPY: ACN 20132

", "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

44 µL

24 µL

R2

15 µL

R3

15 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6.8 µL

Decreased

6.8 µL

10 µL

90 µL

Increased

6.8 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:

12 weeks

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- 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 original IFCC formulation using calibrated pipettes together with a manual photometer providing absolute values and the substrate‑specific absorptivity, ε.

LREFSchumann G, Bonora R, Ceriotti F, et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 4. Reference Procedure for the Measurement of Catalytic Activity Concentration of Alanine Aminotransferase. Clin Chem Lab Med 2002;40(7):718-724.

", "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
U/L

SD
U/L

CV
%

PCCC1a)

49.5

0.457

0.9

PCCC2b)

121

0.607

0.5

Human serum 1

12.0

0.265

2.2

Human serum 2

30.0

0.402

1.3

Human serum 3

49.6

0.440

0.9

Human serum 4

351

1.96

0.6

Human serum 5

620

2.96

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

49.5

0.629

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

121

0.977

0.8

Human serum 1

12.0

0.341

2.9

Human serum 2

31.9

0.469

1.5

Human serum 3

49.6

1.20

2.4

Human serum 4

349

2.75

0.8

Human serum 5

634

3.67

0.6

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

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

Method comparison

ALT 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) = 91

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 = 0.993x + 1.14 U/L

y = 0.992x + 1.22 U/L

τ = 0.987

r = 1.000

The sample activities were between 7.02 and 695 U/L.

ALT 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) = 65

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 = 1.000x + 1.83 U/L

y = 0.978x + 3.53 U/L

τ = 0.974

r = 1.000

The sample activities were between 9.63 and 684 U/L.

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

Summary

Summary
LREFSherwin JE. Liver function. In: Kaplan LA, Pesce AJ, eds. Clinical Chemistry, theory, analysis, and correlation. St. Louis: Mosby 1984;420-438.
,
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.

The enzyme alanine aminotransferase (ALT) has been widely reported as present in a variety of tissues. The major source of ALT is the liver, which has led to the measurement of ALT activity for the diagnosis of hepatic diseases. Elevated serum ALT is found in hepatitis, cirrhosis, obstructive jaundice, carcinoma of the liver, and chronic alcohol abuse. ALT is only slightly elevated in patients who have an uncomplicated myocardial infarction.

Although both serum aspartate aminotransferase (AST) and ALT become elevated whenever disease processes affect liver cell integrity, ALT is the more liver‑specific enzyme. Moreover, elevations of ALT activity persist longer than elevations of AST activity.

The addition of pyridoxal phosphate to the assay causes an increase in aminotransferase activity. The activation is higher for AST than for ALT. Pyridoxal phosphate activation prevents falsely low aminotransferase activity in patient samples with insufficient endogenous pyridoxal phosphate (vitamin B6 deficiency).

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

Reagents - working solutions

Alanine Aminotransferase acc. to IFCC (ALTL)

R1

TRIS buffer: 224 mmol/L, pH 7.3 (37 °C); L‑alanine: 1120 mmol/L; albumin (bovine): 0.25 %; LDH (microorganisms): ≥ 45 µkat/L; stabilizers; preservative

R3

2‑Oxoglutarate: 94 mmol/L; NADH: ≥ 1.7 mmol/L; additives; preservative

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

Pyridoxal phosphate (PYP-ALT, Cat. No 09119922191)

R2

Pyridoxal phosphate: 730 µmol/L; additives; preservative

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.

", "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 12 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:

3 days at 15‑25 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

7 days at 2‑8 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

> 7 days at (−60)‑(−80) °C

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Intended use

In vitro test for the quantitative determination of alanine aminotransferase (ALT) with pyridoxal phosphate activation in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

This assay follows the recommendations of the IFCC, but was optimized for performance and stability.

LREFBergmeyer HU, Hørder M, Rej R. Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes. Part 3. IFCC method for alanine aminotransferase. J Clin Chem Clin Biochem 1986;24:481-495.
,
LREFECCLS. Determination of the catalytic activity concentration in serum of L-alanine aminotransferase (EC 2.6.1.2, ALAT). Klin Chem Mitt 1989;20:204-211.

ALT catalyzes the reaction between L‑alanine and 2‑oxoglutarate. The pyruvate formed is reduced by NADH in a reaction catalyzed by lactate dehydrogenase (LDH) to form L‑lactate and NAD+ . Pyridoxal phosphate serves as a coenzyme in the amino transfer reaction. It ensures full enzyme activation.

L‑Alanine + 2‑oxoglutarate

ALT

pyruvate + L‑glutamate

Pyruvate + NADH + H+

LDH

L‑lactate + NAD+

The rate of the NADH oxidation is directly proportional to the catalytic ALT activity. It is determined by measuring the decrease in absorbance.

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

Limits and ranges

Measuring range

5‑700 U/L (0.08‑11.7 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 5 U/L (0.08 µkat/L)

Limit of Detection

= 5 U/L (0.08 µkat/L)

Limit of Quantitation

= 6 U/L (0.10 µkat/L)

The Limit of Blank, Limit of Detection and 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 activity 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 activity samples.

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

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity alanine aminotransferase samples.

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

Expected values

U/L*

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

10‑50 U/L

Females

10‑35 U/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 50 U/L

Females

up to 35 U/L

*calculated by unit conversion factor

µkat/L

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

0.17‑0.83 µkat/L

Females

0.17‑0.58 µkat/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 0.83 µkat/L

Females

up to 0.58 µkat/L

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 an ALT activity of 35 U/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: 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 170 (approximate hemoglobin concentration: 106 µmol/L or 170 mg/dL).
Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

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 150. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.
Lipemic samples may cause > Abs flagging. Choose diluted sample treatment for automatic rerun.

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.
Exception: Calcium dobesilate can cause artificially low ALT results at therapeutic concentrations.

Cyanokit (Hydroxocobalamin) may cause interference with results.

Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results.

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

08056773 190

Alanine Aminotransferase acc. to IFCC (450 tests)

System‑ID 2013 001

Roche/Hitachi cobas c 503

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 20401

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

08062986 190

Pyridoxal phosphate (950 tests)

System‑ID 2012 001

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

System information

ALTP: ACN 20130

", "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

44 µL

24 µL

R2

15 µL

R3

15 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6.8 µL

Decreased

6.8 µL

10 µL

90 µL

Increased

6.8 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:

12 weeks

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- 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 original IFCC formulation using calibrated pipettes together with a manual photometer providing absolute values and the substrate‑specific absorptivity, ε.

LREFSchumann G, Bonora R, Ceriotti F, et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 4. Reference Procedure for the Measurement of Catalytic Activity Concentration of Alanine Aminotransferase. Clin Chem Lab Med 2002;40(7):718-724.

", "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
U/L

SD
U/L

CV
%

PCCC1a)

49.5

0.457

0.9

PCCC2b)

121

0.607

0.5

Human serum 1

12.0

0.265

2.2

Human serum 2

30.0

0.402

1.3

Human serum 3

49.6

0.440

0.9

Human serum 4

351

1.96

0.6

Human serum 5

620

2.96

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

49.5

0.629

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

121

0.977

0.8

Human serum 1

12.0

0.341

2.9

Human serum 2

31.9

0.469

1.5

Human serum 3

49.6

1.20

2.4

Human serum 4

349

2.75

0.8

Human serum 5

634

3.67

0.6

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

Method comparison

ALT 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) = 91

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 = 0.993x + 1.14 U/L

y = 0.992x + 1.22 U/L

τ = 0.987

r = 1.000

The sample activities were between 7.02 and 695 U/L.

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

Summary

Summary
LREFSherwin JE. Liver function. In: Kaplan LA, Pesce AJ, eds. Clinical Chemistry, theory, analysis, and correlation. St. Louis: Mosby 1984;420-438.
,
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.

The enzyme alanine aminotransferase (ALT) has been widely reported as present in a variety of tissues. The major source of ALT is the liver, which has led to the measurement of ALT activity for the diagnosis of hepatic diseases. Elevated serum ALT is found in hepatitis, cirrhosis, obstructive jaundice, carcinoma of the liver, and chronic alcohol abuse. ALT is only slightly elevated in patients who have an uncomplicated myocardial infarction.

Although both serum aspartate aminotransferase (AST) and ALT become elevated whenever disease processes affect liver cell integrity, ALT is the more liver‑specific enzyme. Moreover, elevations of ALT activity persist longer than elevations of AST activity.

The addition of pyridoxal phosphate to the assay causes an increase in aminotransferase activity. The activation is higher for AST than for ALT. Pyridoxal phosphate activation prevents falsely low aminotransferase activity in patient samples with insufficient endogenous pyridoxal phosphate (vitamin B6 deficiency).

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

Reagents - working solutions

Alanine Aminotransferase acc. to IFCC (ALTL)

R1

TRIS buffer: 224 mmol/L, pH 7.3 (37 °C); L‑alanine: 1120 mmol/L; albumin (bovine): 0.25 %; LDH (microorganisms): ≥ 45 µkat/L; stabilizers; preservative

R3

2‑Oxoglutarate: 94 mmol/L; NADH: ≥ 1.7 mmol/L; additives; preservative

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

Pyridoxal phosphate (PYP, Cat. No 08062986190)

R2

Pyridoxal phosphate: 730 µmol/L; additives; preservative

R2 is in position B.

", "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 12 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:

3 days at 15‑25 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

7 days at 2‑8 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

> 7 days at (−60)‑(−80) °C

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": "0108056773190c503", "ProductName": "ALTP", "ProductLongName": "Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF0000000480770E", "DocumentOriginID": "FF0000000480770E", "MaterialNumbers": [ "08056773190" ], "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 alanine aminotransferase (ALT) with pyridoxal phosphate activation in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

This assay follows the recommendations of the IFCC, but was optimized for performance and stability.

LREFBergmeyer HU, Hørder M, Rej R. Approved recommendation (1985) on IFCC methods for the measurement of catalytic concentration of enzymes. Part 3. IFCC method for alanine aminotransferase. J Clin Chem Clin Biochem 1986;24:481-495.
,
LREFECCLS. Determination of the catalytic activity concentration in serum of L-alanine aminotransferase (EC 2.6.1.2, ALAT). Klin Chem Mitt 1989;20:204-211.

ALT catalyzes the reaction between L‑alanine and 2‑oxoglutarate. The pyruvate formed is reduced by NADH in a reaction catalyzed by lactate dehydrogenase (LDH) to form L‑lactate and NAD+ . Pyridoxal phosphate serves as a coenzyme in the amino transfer reaction. It ensures full enzyme activation.

L‑Alanine + 2‑oxoglutarate

ALT

pyruvate + L‑glutamate

Pyruvate + NADH + H+

LDH

L‑lactate + NAD+

The rate of the NADH oxidation is directly proportional to the catalytic ALT activity. It is determined by measuring the decrease in absorbance.

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

Limits and ranges

Measuring range

5‑700 U/L (0.08‑11.7 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 5 U/L (0.08 µkat/L)

Limit of Detection

= 5 U/L (0.08 µkat/L)

Limit of Quantitation

= 6 U/L (0.10 µkat/L)

The Limit of Blank, Limit of Detection and 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 activity 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 activity samples.

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

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity alanine aminotransferase samples.

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

Expected values

U/L*

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

10‑50 U/L

Females

10‑35 U/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 50 U/L

Females

up to 35 U/L

*calculated by unit conversion factor

µkat/L

Acc. to IFCC/Standard Method 94 with pyridoxal phosphate activation measured at 37 °C:
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

Males

0.17‑0.83 µkat/L

Females

0.17‑0.58 µkat/L

Consensus values with pyridoxal phosphate activation:
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 0.83 µkat/L

Females

up to 0.58 µkat/L

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 an ALT activity of 35 U/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: 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 170 (approximate hemoglobin concentration: 106 µmol/L or 170 mg/dL).
Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

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 150. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.
Lipemic samples may cause > Abs flagging. Choose diluted sample treatment for automatic rerun.

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.
Exception: Calcium dobesilate can cause artificially low ALT results at therapeutic concentrations.

Cyanokit (Hydroxocobalamin) may cause interference with results.

Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results.

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

08056773190

Alanine Aminotransferase acc. to IFCC (450 tests)

System‑ID 2013 001

cobas c 303, cobas c 503

10759350190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

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

08062986190

Pyridoxal phosphate (950 tests)

System‑ID 2012 001

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

System information

ALTP: ACN 20130

", "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

44 µL

24 µL

R2

15 µL

R3

15 µL

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

6.8 µL

Decreased

6.8 µL

10 µL

90 µL

Increased

6.8 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:

12 weeks

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- 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 original IFCC formulation using calibrated pipettes together with a manual photometer providing absolute values and the substrate‑specific absorptivity, ε.

LREFSchumann G, Bonora R, Ceriotti F, et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 4. Reference Procedure for the Measurement of Catalytic Activity Concentration of Alanine Aminotransferase. Clin Chem Lab Med 2002;40(7):718-724.

", "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
U/L

SD
U/L

CV
%

PCCC1a)

49.5

0.457

0.9

PCCC2b)

121

0.607

0.5

Human serum 1

12.0

0.265

2.2

Human serum 2

30.0

0.402

1.3

Human serum 3

49.6

0.440

0.9

Human serum 4

351

1.96

0.6

Human serum 5

620

2.96

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

49.5

0.629

1.3

PCCC2

FREFPreciControl ClinChem Multi 2

121

0.977

0.8

Human serum 1

12.0

0.341

2.9

Human serum 2

31.9

0.469

1.5

Human serum 3

49.6

1.20

2.4

Human serum 4

349

2.75

0.8

Human serum 5

634

3.67

0.6

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

Method comparison

ALT 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) = 91

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 = 0.993x + 1.14 U/L

y = 0.992x + 1.22 U/L

τ = 0.987

r = 1.000

The sample activities were between 7.02 and 695 U/L.

ALT 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) = 65

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 = 1.000x + 1.83 U/L

y = 0.978x + 3.53 U/L

τ = 0.974

r = 1.000

The sample activities were between 9.63 and 684 U/L.

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

Summary

Summary
LREFSherwin JE. Liver function. In: Kaplan LA, Pesce AJ, eds. Clinical Chemistry, theory, analysis, and correlation. St. Louis: Mosby 1984;420-438.
,
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.

The enzyme alanine aminotransferase (ALT) has been widely reported as present in a variety of tissues. The major source of ALT is the liver, which has led to the measurement of ALT activity for the diagnosis of hepatic diseases. Elevated serum ALT is found in hepatitis, cirrhosis, obstructive jaundice, carcinoma of the liver, and chronic alcohol abuse. ALT is only slightly elevated in patients who have an uncomplicated myocardial infarction.

Although both serum aspartate aminotransferase (AST) and ALT become elevated whenever disease processes affect liver cell integrity, ALT is the more liver‑specific enzyme. Moreover, elevations of ALT activity persist longer than elevations of AST activity.

The addition of pyridoxal phosphate to the assay causes an increase in aminotransferase activity. The activation is higher for AST than for ALT. Pyridoxal phosphate activation prevents falsely low aminotransferase activity in patient samples with insufficient endogenous pyridoxal phosphate (vitamin B6 deficiency).

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

Reagents - working solutions

Alanine Aminotransferase acc. to IFCC (ALTL)

R1

TRIS buffer: 224 mmol/L, pH 7.3 (37 °C); L‑alanine: 1120 mmol/L; albumin (bovine): 0.25 %; LDH (microorganisms): ≥ 45 µkat/L; stabilizers; preservative

R3

2‑Oxoglutarate: 94 mmol/L; NADH: ≥ 1.7 mmol/L; additives; preservative

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

Pyridoxal phosphate (PYP, Cat. No 08062986190)

R2

Pyridoxal phosphate: 730 µmol/L; additives; preservative

R2 is in position B.

", "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.

", "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 12 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:

3 days at 15‑25 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

7 days at 2‑8 °C

LREFHeins M, Heil W, Withold W. Storage of Serum or Whole Blood Samples? Effect of Time and Temperature on 22 Serum Analytes. Eur J Clin Chem Clin Biochem 1995;33:231-238.

> 7 days at (−60)‑(−80) °C

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" } ] } } ] }

ALTP

Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation

IVD For in vitro diagnostic use.
ALTP

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