The Development of a Standardized Quality Assessment Material to Support Xpert® HIV-1 Viral Load Testing for ART Monitoring in South Africa
| Autor: | Pedro Da Silva, Lara Noble, Wendy S. Stevens, Lesley Scott, Asiashu Bongwe |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty PrimeStore MTM0 viruses 030106 microbiology Clinical Biochemistry Human immunodeficiency virus (HIV) medicine.disease_cause Plasma viral load 03 medical and health sciences 0302 clinical medicine HIV viral load Internal medicine External quality assessment Medicine biochemistry Viral rna 030212 general & internal medicine lcsh:R5-920 business.industry Quality assessment virus diseases thermostable external quality assessment Confidence interval Concordance correlation coefficient quality business verification lcsh:Medicine (General) Viral load |
| Zdroj: | Diagnostics, Vol 11, Iss 160, p 160 (2021) Diagnostics Volume 11 Issue 2 |
| ISSN: | 2075-4418 |
| Popis: | 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 (&rho c) of 0.997 (95% confidence interval (CI): 0.996 to 0.998) and a mean bias of &minus 0.019 log copies per milliliter (cp/mL) (95% CI: &minus 0.044 to 0.063). The overall EQA &rho 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. |
| Databáze: | OpenAIRE |
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