Intermethod calibration of alanine aminotransferase (ALT) and γ-glutamyltransferase (GGT) results: application to Fibrotest® and Actitest® scores
-
Georges Férard
Abstract
Two multi-component scores (Fibrotest® and Actitest®) have been proposed to evaluate liver fibrosis or necro-inflammatory lesions as an alternative to liver biopsy. This approach requires standardization of alanine aminotransferase (ALT) and γ-glutamyltransferase (GGT) determinations. For this purpose, ALT and GGT values were assigned to a multi-enzyme material using the appropriate primary reference procedure. This material was used as a common calibrator for sera from 20 patients with viral hepatitis. Measurements were carried out in 11 laboratories, using their own automated routine methods and compared to results obtained using the primary reference procedure. The expression of results in multiples of the upper reference limit worsened the inter-laboratory variation for both enzymes. The multi-enzyme material was commutable for ALT and GGT determination carried out with six analytical systems. Common calibration significantly improved inter-laboratory consistency, which finally reached 1.8% and 3.3% for ALT and GGT, respectively. For each enzyme, it also permitted the retention of a common reference interval for a set of calibrated methods and the improvement of inter-laboratory coherency of Fibrotest® and Actitest® scores.
References
1. Imbert-Bismut F, Ratziu V, Pieroni L, Charlotte F, Benhamou Y, Poynard T. Biochemical markers of liver fibrosis in patients with hepatitis C virus infections: a prospective study. Lancet 2001; 357:1069–75.10.1016/S0140-6736(00)04258-6Search in Google Scholar
2. Halfon P, Imbert-Bismut F, Messous D, Antoniotti G, Benchetrit D, Cart-Lamy P, et al. A prospective assessment of the inter-laboratory variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) in patients with chronic liver disease. Comp Hepatol 2002; 1:3.10.1186/1476-5926-1-3Search in Google Scholar
3. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PFH, 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 concentration of alanine aminotransferase [L-alanine:2-oxoglutarate aminotransferase (ALT), EC 2.6.1.2]. Clin Chem Lab Med 2002; 40:718–24.Search in Google Scholar
4. Schumann G, Bonora R, Ceriotti F, Férard G, Ferrero CA, Franck PFH, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 6. Reference procedure for the measurement of catalytic concentration of γ-glutamyltransferase. Clin Chem Lab Med 2002; 40:734–8.Search in Google Scholar
5. Wahefeld AN, Herz G, Bernt E. Modification of the Malloy-Evelyn method for a simple, reliable determination of total bilirubin in serum. Scand J Lab Invest 1972; 29(Suppl 26):11–2.Search in Google Scholar
6. Aoki R, Hirayama T, Ueda S, Imamura S, Misaki H. Development of lyophilized multi-enzyme material as secondary reference material. Clin Chem Lab Med 2002; 40(Suppl):227.Search in Google Scholar
7. Bedossa P, Poynard T, and the METAVIR Cooperative Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. The French METAVIR Cooperative Study Group. Hepatology 1994; 20:15–20.Search in Google Scholar
8. Passing H, Bablok W. A new biometrical procedure for testing the equality of measurement from two different analytical methods. J Clin Chem Clin Biochem 1983; 21:709–20.Search in Google Scholar
9. Schumann G, Bonora R, Ceriotti F, Clerc-Renaud P, Férard G, Ferrero CA, et al. IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37°C. Part 7. Certification of four reference materials for the determination of γ-glutamyltransferase, lactate dehydrogenase, alanine aminotransferase and creatine kinase at 37°C. Clin Chem Lab Med 2002; 40:739–45.Search in Google Scholar
10. Myara A, Guechot J, Imbert-Bismut F, Lasnier E, Piton A, Voitot H, et al. Harmonization of liver enzyme results: calibration for aminotransferases and gammaglutamyltransferase. J Hepatol 2004; 4:501–2.10.1016/j.jhep.2004.04.036Search in Google Scholar
11. Férard G, Edwards J, Kanno T, Lessinger JM, Moss D, Schiele F, et al. Validation of an enzyme calibrator. An IFCC guideline. Clin Biochem 1998; 31:495–500.10.1016/S0009-9120(98)00039-3Search in Google Scholar
12. ISO 18153:2003. In vitro diagnostic medical devices – measurement of quantities in biological samples – metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials.Search in Google Scholar
13. Ferrero CA, Carobene A, Ceriotti F, Modenese A, Arcelloni C. Behavior of frozen serum pools and lyophilised sera in an external quality-assessment scheme. Clin Chem 1995; 41:575–80.10.1093/clinchem/41.4.575Search in Google Scholar
14. Dufour DR, Lott JA, Nolte FS, Gretch DR, Koff RS, Seeff LB. Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem 2000; 46:2027–49.10.1093/clinchem/46.12.2027Search in Google Scholar
15. Panteghini M, Ceriotti F, Schumann G, Siekmann L. Establishing a reference system in clinical enzymology. Clin Chem Lab Med 2002; 39:785–800.Search in Google Scholar
©2006 by Walter de Gruyter Berlin New York
Articles in the same Issue
- Natriuretic peptides and evidence-based quality specifications
- Preanalytical variability: the dark side of the moon in laboratory testing
- Clinical relevance of biological variation: the lesson of brain natriuretic peptide (BNP) and NT-proBNP assay
- Hepatorenal syndrome
- Modified Levey-Jennings charts for calculated laboratory tests
- Increased free malondialdehyde concentrations in smokers normalise with a mixed fruit and vegetable juice concentrate: a pilot study
- The exponentially weighted moving average (EWMA) rule compared with traditionally used quality control rules
- Intermethod calibration of alanine aminotransferase (ALT) and γ-glutamyltransferase (GGT) results: application to Fibrotest® and Actitest® scores
- Comparison of TEST 1 with SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood
- Multicenter evaluation of the interference of hemoglobin, bilirubin and lipids on Synchron LX-20 assays
- Technical evaluation of the Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay
- Erythrocyte membrane Na+,K+-ATPase and Mg2+-ATPase activities in subjects with methylenetetrahydrofolate reductase (MTHFR) 677 C→T genotype and moderate hyperhomocysteinaemia. The role of L-phenylalanine and L-alanine
- Matrix metalloproteinases and their inhibitors in different acute stroke subtypes
- Pyrosequencing protocol requiring a unique biotinylated primer
- Detection of antibodies against 60-, 65- and 70-kDa heat shock proteins in paediatric patients with various disorders using Western blotting and ELISA
- Quantitative determination of erythrocyte folate vitamer distribution by liquid chromatography-tandem mass spectrometry
- Time-level relationship between indicators of oxidative stress and Glasgow Coma Scale scores of severe head injury patients
- Stepwise strategies in analysing haematuria and leukocyturia in screening
- Elevation of serum cerebral injury markers correlates with serum choline decline after coronary artery bypass grafting surgery
- Drug screening in urine by cloned enzyme donor immunoassay (CEDIA) and kinetic interaction of microparticles in solution (KIMS): a comparative study
- Release of anandamide from blood cells
- Rapid decrease in plasma D-lactate as an early potential predictor of diminished 28-day mortality in critically ill septic shock patients
- Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry
- Sample processing and its preanalytical impact on the measurement of circulating matrix metalloproteinases
- Physiological matrix metalloproteinase (MMP) concentrations: comparison of serum and plasma specimens
- Importance of the functional sensitivity determination of a serum hyaluronic acid assay for the prediction of liver fibrosis in patients with features of the metabolic syndrome
- The dilemma of invasive and non-invasive investigations for adult and paediatric non-alcoholic fatty liver disease: has the time come for a new biochemical marker?
- Is cystatin C a reliable renal marker in trauma?
- On the independence of intraindividual reference values
- Sixth International Symposium on Molecular Diagnostics, Graz, Austria, May 25-27, 2006
Articles in the same Issue
- Natriuretic peptides and evidence-based quality specifications
- Preanalytical variability: the dark side of the moon in laboratory testing
- Clinical relevance of biological variation: the lesson of brain natriuretic peptide (BNP) and NT-proBNP assay
- Hepatorenal syndrome
- Modified Levey-Jennings charts for calculated laboratory tests
- Increased free malondialdehyde concentrations in smokers normalise with a mixed fruit and vegetable juice concentrate: a pilot study
- The exponentially weighted moving average (EWMA) rule compared with traditionally used quality control rules
- Intermethod calibration of alanine aminotransferase (ALT) and γ-glutamyltransferase (GGT) results: application to Fibrotest® and Actitest® scores
- Comparison of TEST 1 with SRS 100 and ICSH reference method for the measurement of the length of sedimentation reaction in blood
- Multicenter evaluation of the interference of hemoglobin, bilirubin and lipids on Synchron LX-20 assays
- Technical evaluation of the Beckman Coulter OV-Monitor (CA 125 antigen) immunoassay
- Erythrocyte membrane Na+,K+-ATPase and Mg2+-ATPase activities in subjects with methylenetetrahydrofolate reductase (MTHFR) 677 C→T genotype and moderate hyperhomocysteinaemia. The role of L-phenylalanine and L-alanine
- Matrix metalloproteinases and their inhibitors in different acute stroke subtypes
- Pyrosequencing protocol requiring a unique biotinylated primer
- Detection of antibodies against 60-, 65- and 70-kDa heat shock proteins in paediatric patients with various disorders using Western blotting and ELISA
- Quantitative determination of erythrocyte folate vitamer distribution by liquid chromatography-tandem mass spectrometry
- Time-level relationship between indicators of oxidative stress and Glasgow Coma Scale scores of severe head injury patients
- Stepwise strategies in analysing haematuria and leukocyturia in screening
- Elevation of serum cerebral injury markers correlates with serum choline decline after coronary artery bypass grafting surgery
- Drug screening in urine by cloned enzyme donor immunoassay (CEDIA) and kinetic interaction of microparticles in solution (KIMS): a comparative study
- Release of anandamide from blood cells
- Rapid decrease in plasma D-lactate as an early potential predictor of diminished 28-day mortality in critically ill septic shock patients
- Evaluation of an immunoassay of whole blood sirolimus in pediatric transplant patients in comparison with high-performance liquid chromatography/tandem mass spectrometry
- Sample processing and its preanalytical impact on the measurement of circulating matrix metalloproteinases
- Physiological matrix metalloproteinase (MMP) concentrations: comparison of serum and plasma specimens
- Importance of the functional sensitivity determination of a serum hyaluronic acid assay for the prediction of liver fibrosis in patients with features of the metabolic syndrome
- The dilemma of invasive and non-invasive investigations for adult and paediatric non-alcoholic fatty liver disease: has the time come for a new biochemical marker?
- Is cystatin C a reliable renal marker in trauma?
- On the independence of intraindividual reference values
- Sixth International Symposium on Molecular Diagnostics, Graz, Austria, May 25-27, 2006