Evaluation of the performance of a qPCR-based assay for HIV-1 viral load determination.

ABSTRACT:

Objective

According to the YY/T 1182-2010 standard of the People's Republic of China on nucleic acid amplification test reagents (kits) for medical industry, the accuracy, precision, linear range, and analytic sensitivity of HIV-1 standardized quality control products should be assessed. The Geneway HIV-1 Nucleic Acid Detection Kit from China has been successfully registered with the National Medical Products Administration. Here, we aimed to assess for the first time its detection performance.

Methods

The accuracy, precision, analytic sensitivity, and linearity of the Geneway HIV-1 nucleic acid quantification test kit were analyzed using a series of diluted standard control samples of HIV-1 negative plasma. Clinical plasma samples were collected from 163 HIV-infected patien

SUBMITTER: Lin B 

PROVIDER: S-EPMC11642942 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature