Establishment and Characterization of the First Chinese National Standard for Nucleic Acid Amplification Technology Assays for Hepatitis E Virus Nucleic Acid Detection.

ABSTRACT: The detection of hepatitis E virus (HEV) RNA is the gold standard for HEV infection diagnosis. In order to address the quality control requirements for HEV RNA detection kits within China, we aimed to establish the first Chinese national standard for HEV RNA detection through a collaborative study. The candidate standard was quantified using digital PCR (dPCR). A total of five laboratories were invited to determine the estimated mean value of this national standard relative to the World Health Organization International Standard (WHO IS). Additionally, four commercial kits were used to assess the applicability of the candidate standard. The stability was determined by freeze-thaw cycles and storage at 37 °C, 25 °C and 4 °C. The estimated mean value of this national standard relative to the

SUBMITTER: Li M 

PROVIDER: S-EPMC10610164 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature