Performance of Celera RUO integrase resistance assay across multiple HIV-1 subtypes.

ABSTRACT:

Background

HIV-1 sequence variation is a major obstacle to developing molecular based assays for multiple subtypes. This study sought to independently assess performance characteristics of the ViroSeq™ HIV-1 Integrase RUO Genotyping Kit (Celera, US) for samples of multiple different HIV-1 subtypes.

Methods

264 samples were tested in the validation, 106 from integrase inhibitor naïve patients' sent for routine HIV-1 drug resistance testing after failing a 1st- or 2nd-line regimen, and 158 samples from an external virology quality assurance program (VQA). For the latter, 53 unique VQA samples were tested in two to five different laboratories to assess assay reproducibility. For all assays, viral RNA was extracted using the ViroSeq extraction module, reverse transcribed, and am

SUBMITTER: Wallis CL 

PROVIDER: S-EPMC5292360 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature