Establishment of the First International Standard for Nucleic Acid Amplification Technology (NAT) Assays for HCV RNA

Abstract

Sample AA was accepted as the candidate standard and assigned a titre of 10(5) international units (IU)/ml. The International Standard consists of a batch of vials each containing 50,000 IU/vial. Preliminary studies indicated that the material is stable at +4 degrees C and +20 degrees C for up to 200 days.

Use and interpretation of virological tests for hepatitis C

“…The World Health Organization (WHO) has now established an international standard for universal standardization of HCV RNA quantification units. 35 An IU for HCV RNA has been arbitrarily defined using this standard. 35,36 It does not represent the actual number of viral particles in a sample, but rather the amount of HCV RNA.…”

APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing

“…Inhouse testing with traditional endpoint PCR for viral loads, which is used widely across the Asia-Pacific region, is not encouraged due to its limited dynamic range compared with commercial, sensitive PCR assays [166]. Such assays should be calibrated to the World Health Organization (WHO) International Standard [167].…”

An Overview of the Laboratory Assay Systems and Reactives Used in the Diagnosis of Hepatitis C Virus (HCV) Infections

“…NAT assays are used to detect and quantify HCV RNA. 8,18,40 HCV RNA assay systems can be divided into two groups: qualitative and quantitative HCV RNA.…”