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Article

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

1
Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2000, Gauteng, South Africa
2
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)
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 (ρc) 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 ρc (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 HIV viral load; external quality assessment; verification; quality; thermostable; PrimeStore MTM0
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MDPI and ACS Style

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 D., Lesley E. Scott, Asiashu Bongwe, Pedro Da Silva, and Wendy S. 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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