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Analytical variability of the Fibrotest proteins
Maria Alessandra Rosenthal-Allieri1, Marie-Line Peritore, Albert Tran
1Laboratoire central d'Immunologie, CHU de Nice, Hôpital de l'Archet 1, Rte de St. Antoine de Ginestière, Nice, France. allieri@unice.fr
Clinical Biochemistry
|April 12, 2005
Summary
Analytical variability in Fibrotest (FT) proteins like haptoglobin, apolipoprotein A1, and alpha2 macroglobulin impacts routine use. Discrepancies persist even after standardization, highlighting the need for quality control programs.
Area of Science:
- Clinical chemistry
- Hepatology
- Biomarker analysis
Background:
- The Fibrotest (FT) is used to assess liver fibrosis, but its analytical variability is a concern for routine clinical application.
- Standardization efforts by the International Federation of Clinical Chemistry (IFCC) have improved some protein assays, yet data on FT protein transferability remain limited.
Purpose of the Study:
- To evaluate the analytical variability of key Fibrotest proteins: haptoglobin, apolipoprotein A1, and alpha2 macroglobulin.
- To assess the transferability of FT protein measurements between different autoanalyzer platforms.
Main Methods:
- Analysis of 112 sera from hepatitis C patients within the FIBROPACA study.
- Comparison of haptoglobin, apolipoprotein A1, and alpha2 macroglobulin measurements using Immage (Beckman-Coulter) and BNProspec (Dade-Behring) autoanalyzers.
Main Results:
- Haptoglobin measurements showed optimal concordance (correlation coefficient = 0.98).
- Apolipoprotein A1 measurements were 12% lower with Immage compared to BNProspec (correlation coefficient = 0.91).
- Alpha2 macroglobulin values were 40% higher with Immage than with BNProspec (correlation coefficient = 0.96).
Conclusions:
- Significant inter-technique analytical variability exists for Fibrotest proteins, particularly alpha2 macroglobulin and apolipoprotein A1.
- Even after IFCC standardization, discrepancies in protein assays necessitate ongoing monitoring.
- National and international quality control programs are recommended to ensure the analytical performance of protein assays used in Fibrotest.