Intra-laboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors
-
Françoise Imbert-Bismut
Abstract
Combinations of tests comprising α2-macroglobulin, haptoglobin, apolipoprotein A1, γ-glutamyltransferase, total bilirubin (Fibrotest) and alanine aminotransferase (Actitest) are being developed as alternatives to liver biopsy in patients with chronic hepatitis C. The aim of this study was to assess in the same laboratory the impact of parameter assay variations on Fibrotest and Actitest results and intra-patient reproducibility of the two tests. The stability of the samples for each test was studied after storage at −80° and −20°. Within-run, between-run and total imprecision for each parameter assay, and for Fibrotest and Actitest results, were determined. Transferability of assay results between different analyzers was studied. Intrapatient reproducibility was assessed in 55 hospitalized patients. Fibrotest and Actitest reference ranges were determined in 300 blood donors (reference group). The stability of the parameters was affected by serum storage at −20° only. The impact of parameter analytical variability on Fibrotest and Actitest results was less than 10% and intra-patient reproducibility was acceptable (p>0.05). The transferability between different analyzers of results of assays performed under the same standardized and calibration conditions was excellent. Fibrotest and Actitest reference ranges in blood donors were (mean±SE) 0.075±0.004 and 0.068±0.004, respectively. The low intra-laboratory and intra-patient variability in Fibrotest and Actitest results confirm Fibrotest and Actitest reliability.
Copyright © 2004 by Walter de Gruyter GmbH & Co. KG
Articles in the same Issue
- Phage-displayed recombinant single-chain antibody fragments with high affinity for cholesteryl ester transfer protein (CETP): cDNA cloning, characterization and CETP quantification
- Stem cell factor and macrophage-colony stimulating factor in patients with pancreatic cancer
- Modulation of plasma fibrinogen levels in acute-phase response after hepatectomy
- Anti-nucleosome, anti-chromatin, anti-dsDNA and anti-histone antibody reactivity in systemic lupus erythematosus
- Expression of activation molecules in neutrophils, monocytes and lymphocytes from patients with unstable angina treated with stent implantation
- Acid ribonuclease and alkaline ribonuclease isoenzymes in plasma of patients with decreased glomerular filtration rate
- Is calcium oxalate nucleation in postprandial urine of males with idiopathic recurrent calcium urolithiasis related to calcium phosphate nucleation and the intensity of stone formation? Studies allowing insight into a possible role of urinary free citrate and protein
- Significance of consecutive international normalized ratio (INR) outcomes using statistical control rules in long-term anticoagulated patients. Optimization of laboratory monitoring and interpretation of borderline measurements
- Clinical trials and p-values, beware of the extremes
- Age dependence of serum β-N-acetylhexosaminidase (NAG) activity
- Elevated plasma total homocysteine in centenarians
- New methodology of influential point detection in regression model building for the prediction of metabolic clearance rate of glucose
- Intra-laboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors
- The glutathione S-transferase polymorphisms in a control population and in Alzheimer's disease patients
- Near-patient testing for infection using urinalysis and immuno-chromatography strips
- Long-distance mountain biking does not disturb the measurement of total, free or complexed prostate-specific antigen in healthy men
- Development of a new colorimetric method for protein S activity measurement
- Re.: Correction to the IFCC primary reference method for the measurement of catalytic activity concentration of enzymes at 37C- part 2: reference procedure for the measurement of creatine kinase. Clin Chem Lab Med 2002;40:635-42
- Meetings and Awards
Articles in the same Issue
- Phage-displayed recombinant single-chain antibody fragments with high affinity for cholesteryl ester transfer protein (CETP): cDNA cloning, characterization and CETP quantification
- Stem cell factor and macrophage-colony stimulating factor in patients with pancreatic cancer
- Modulation of plasma fibrinogen levels in acute-phase response after hepatectomy
- Anti-nucleosome, anti-chromatin, anti-dsDNA and anti-histone antibody reactivity in systemic lupus erythematosus
- Expression of activation molecules in neutrophils, monocytes and lymphocytes from patients with unstable angina treated with stent implantation
- Acid ribonuclease and alkaline ribonuclease isoenzymes in plasma of patients with decreased glomerular filtration rate
- Is calcium oxalate nucleation in postprandial urine of males with idiopathic recurrent calcium urolithiasis related to calcium phosphate nucleation and the intensity of stone formation? Studies allowing insight into a possible role of urinary free citrate and protein
- Significance of consecutive international normalized ratio (INR) outcomes using statistical control rules in long-term anticoagulated patients. Optimization of laboratory monitoring and interpretation of borderline measurements
- Clinical trials and p-values, beware of the extremes
- Age dependence of serum β-N-acetylhexosaminidase (NAG) activity
- Elevated plasma total homocysteine in centenarians
- New methodology of influential point detection in regression model building for the prediction of metabolic clearance rate of glucose
- Intra-laboratory analytical variability of biochemical markers of fibrosis (Fibrotest) and activity (Actitest) and reference ranges in healthy blood donors
- The glutathione S-transferase polymorphisms in a control population and in Alzheimer's disease patients
- Near-patient testing for infection using urinalysis and immuno-chromatography strips
- Long-distance mountain biking does not disturb the measurement of total, free or complexed prostate-specific antigen in healthy men
- Development of a new colorimetric method for protein S activity measurement
- Re.: Correction to the IFCC primary reference method for the measurement of catalytic activity concentration of enzymes at 37C- part 2: reference procedure for the measurement of creatine kinase. Clin Chem Lab Med 2002;40:635-42
- Meetings and Awards
