The Development of a Standardized Quality Assessment Material to Support Xpert^® HIV-1 Viral Load Testing for ART Monitoring in South Africa.

ABSTRACT: The tiered laboratory framework for human immunodeficiency virus (HIV) viral load monitoring accommodates a range of HIV viral load testing platforms, with quality assessment critical to ensure quality patient testing. HIV plasma viral load testing is challenged by the instability of viral RNA. An approach using an RNA stabilizing buffer is described for the Xpert^® HIV-1 Viral Load (Cepheid) assay and was tested in remote laboratories in South Africa. Plasma panels with known HIV viral titres were prepared in PrimeStore molecular transport medium for per-module verification and per-instrument external quality assessment. The panels were transported at ambient temperatures to 13 testing laboratories during 2017 and 2018, tested according to standard procedures and uploaded to a w

SUBMITTER: Noble LD 

PROVIDER: S-EPMC7911816 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature