Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study

摘要: A national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification precore/core mutants. The panel consisted 12 DNA-positive samples VLs from 2.8 9.1 log(10) copies/ml, different genotypes (A F), and 3 mutant 9 wild-type at nucleotide 1896. coefficients variation mean ranged 2.4% 10.4% Cobas Monitor assay, 1.8% 5.5% TaqMan 48, 1.5 26.2% RealArt PCR, 0 7% branched DNA (bDNA). assay underestimated genotype F samples, differences ranging 1.4 2.4 copies/ml. accuracies determinations 33% 100%, those precore 25 100%. This showed some drawbacks two widely used assays: has a narrow dynamic range underestimates sample bDNA shows poor sensitivity may fail identify patients low VLs. With higher performance terms analytical combined larger an ability quantify main equally, real-time PCR methods appear more appropriate for accurate monitoring quantification. Furthermore, clinical implications genotyping determination mutants need be clearly stated justify standardization these methods.