Collaborative study to calibrate hepatitis C virus genotypes 2-6 against the HCV International Standard, 96/790 (genotype 1).
OBJECTIVE
A major requirement of a hepatitis C virus (HCV) RNA nucleic acid amplification technology (NAT) assay validation is the ability of the assay to detect the six major genotypes of HCV with equivalent sensitivities. The aim of this study was to characterize and calibrate an HCV genotype panel for use in such studies.


METHODS
Panels consisting of the first International Standard (IS) for HCV RNA NAT assays (96/790; HCV genotype 1a) and isolates of genotypes 2-6 were sent to 17 laboratories worldwide which use a variety of NAT tests, both qualitative and quantitative. The HCV RNA content of each panel member was determined and the mean titre calculated in International Units/ml (IU/ml).


RESULTS
The calculated mean titres (calibrated against the HCV International Standard), in log10 IU/ml, of the genotype 2-6 samples were 3.99, 3.81, 4.14, 4.18 and 4.61, respectively.


CONCLUSIONS
An HCV genotype panel, calibrated in IU/ml, has been established and should be valuable for assay validation. All the genotypes were detected by all the assays used, but it was not possible to demonstrate that the genotypes were detected with equal efficiencies.
Saldanha
J
J
Division of Virology, National Institute for Biological Standards and Control, South Mimms, Herts., UK.
Heath
A
A
D002138:Calibration; D003299:Cooperative Behavior; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006801:Humans; D007391:International Cooperation; D021141:Nucleic Acid Amplification Techniques / Q000592:standards; D012367:RNA, Viral / Q000032:analysis* / Q000592:standards; D012015:Reference Standards; D012680:Sensitivity and Specificity
D012367:RNA, Viral