Analytical performance verification of a high throughput system for Hepatitis B and Hepatitis C viral load quantifications.

ABSTRACT:

Objective

To verify the analytical performance of cobas® HBV PCR and cobas® HCV PCR assays with Abbott m2000 RealTime System as the reference method.

Design

De-identified residual, archived patient specimens, and College of American Pathologists (CAP) proficiency testing samples were used. Analytical parameters verified were accuracy, precision, limit of detection (LOD), linear range, and cross-contamination. Experiments were designed in accordance with Clinical Laboratories Standards Institute (CLSI) guidelines and CAP standards. Analysis of accuracy was done through regression plots and Bland Altman analyses. Precision was analyzed through coefficient of variation and ANOVA; LOD through probit analysis; and linear range through polynomial fit analysis.

Results

The r

SUBMITTER: Aijaz J 

PROVIDER: S-EPMC10462671 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature