Standardized hepatitis C virus RNA panels for nucleic acid testing assays

Background: Methods for the quantification of hepatitis C virus (HCV) RNA are useful in the clinical management of infected patients. However, the introduction of assays based upon various nucleic acid testing (NAT) technologies, each utilizing a different set of standards, creates the potential for misinterpretation of patient results. Objective: In order to address the need for worldwide standardization of these assays, a HCV RNA quantification panel (NAP™ HCV-RNA) calibrated against the World Health Organization (WHO) First International Standard for HCV RNA was prepared. The eight-member HCV RNA quantification panel was evaluated utilizing a variety of commercially available and in-house NAT technologies. Study design: NAP™ HCV-RNA panels were tested and analyzed using the methods and data reduction protocols specific to each NAT technology employed in this study (bDNA, TMA and two PCR methods). Proprietary units of measure from each assay were compared to WHO International Units (IU) for each panel member (0, 50, 500, 5000, 50 000, 200 000, 500 000 and 2 000 000 IU/ml). Results: Evaluation of the NAP™ HCV-RNA in a variety of NAT procedures demonstrated linearity across the range of target concentrations detected in each assay and R 2 values ranged from 0.9929 to 0.9995 across the four technologies. As expected, the correspondence of assay specific proprietary units to IU differed depending upon the technology utilized. Conclusions: NAP™ HCV-RNA provides a consistent, standardized method for comparing results across laboratories and technologies and is useful in ensuring the quality of NAT testing for HCV RNA, independent of the methodology used.