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

Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, Gauteng, South Africa

National Priority Program, National Health Laboratory Service, Johannesburg 2000, Gauteng, South Africa

Author to whom correspondence should be addressed.

Academic Editor: Alessandro Russo

Diagnostics 2021, 11(2), 160; https://doi.org/10.3390/diagnostics11020160

Received: 30 November 2020 / Revised: 17 January 2021 / Accepted: 19 January 2021 / Published: 22 January 2021

(This article belongs to the Special Issue HIV Diagnosis, Treatment, and Care)

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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 web portal for analysis. A total of 275 quality assessment specimens (57 verification panels and two EQA cycles) were tested. All participating laboratories met study verification criteria (n = 171 specimens) with an overall concordance correlation coefficient (ρ_c) of 0.997 (95% confidence interval (CI): 0.996 to 0.998) and a mean bias of −0.019 log copies per milliliter (cp/mL) (95% CI: −0.044 to 0.063). The overall EQA ρ_c (n = 104 specimens) was 0.999 (95% CI: 0.998 to 0.999), with a mean bias of 0.03 log cp/mL (95% CI: 0.02 to 0.05). These panels are suitable for use in quality monitoring of Xpert^® HIV-1 VL and are applicable to laboratories in remote settings. View Full-Text

Keywords: HIV viral load; external quality assessment; verification; quality; thermostable; PrimeStore MTM0

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Noble, L.D.; Scott, L.E.; Bongwe, A.; Da Silva, P.; Stevens, W.S. The Development of a Standardized Quality Assessment Material to Support Xpert^® HIV-1 Viral Load Testing for ART Monitoring in South Africa. Diagnostics 2021, 11, 160. https://doi.org/10.3390/diagnostics11020160

AMA Style

Noble LD, Scott LE, Bongwe A, Da Silva P, Stevens WS. The Development of a Standardized Quality Assessment Material to Support Xpert^® HIV-1 Viral Load Testing for ART Monitoring in South Africa. Diagnostics. 2021; 11(2):160. https://doi.org/10.3390/diagnostics11020160

Chicago/Turabian Style

Noble, Lara Dominique, Lesley Erica Scott, Asiashu Bongwe, Pedro Da Silva, and Wendy Susan Stevens. 2021. "The Development of a Standardized Quality Assessment Material to Support Xpert^® HIV-1 Viral Load Testing for ART Monitoring in South Africa" Diagnostics 11, no. 2: 160. https://doi.org/10.3390/diagnostics11020160

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

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