Performance Evaluation of In Vitro Screening and Diagnostic Kits for Hepatitis C Virus Infection.

ABSTRACT:

Aim

A reliable kit with high sensitivity and specificity is indispensable for diagnosing hepatitis C virus (HCV) infection. Detection kits for anti-HCV antibodies (anti-HCV) are used for screening, and quantification kits for HCV RNA and HCV antigen (Ag) are used for the definite diagnosis of HCV infection or the evaluation of the pathological condition of and therapeutic effects in patients with chronic hepatitis C. Several kits are currently available for these purposes and are provided for clinical use in Japan. In this study, we aimed to evaluate the performance of these kits.

Methods

We used International Standards for HCV RNA and HCV Ag and a regional reference panel to evaluate the performance of thirteen anti-HCV, five HCV RNA, and two HCV Ag kits.

Results

All

SUBMITTER: Murayama A 

PROVIDER: S-EPMC8851425 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature