Identification of material for development of indigenous HCV standard for qualitative nucleic acid amplification techniques, a make in India initiative

Background: The WHO HCV NAT international standard is being used by manufacturers of molecular in vitro diagnostics (IVDs), blood transfusion units, quality evaluation authorities and diagnostic laboratories in the validation of HCV NAT assays and to calibrate secondary reference materials. First WHO HCV NAT international standard was established in 1997 and even after 18 years of its establishment, we do not see the availability of indigenous HCV NAT standard in India. All versions of HCV NAT international standard comprised of HCV genotype-1 as per its dominancy in western countries. The purpose of this study is to identify suitable material for development of indigenous HCV NAT standard consisting of HCV genotype-3, which is dominant in larger part of India.