Dataset Information

Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, & m-PIMA HIV-1/2 Viral Load in South African Clinics.

ABSTRACT:

Background

We aimed to evaluate the analytic performance of 3 rapid HIV viral load assays: the novel Xpert HIV-1 VL XC (Xpert XC), Xpert HIV-1 VL (Xpert VL), and m-PIMA HIV-1/2 VL (m-PIMA).

Setting

Two South African clinics.

Methods

We conducted a prospective diagnostic accuracy study. Site-laboratory technicians and nurses used the Xpert XC, Xpert VL, and m-PIMA to test plasma samples from people with HIV receiving antiretroviral therapy. We compared results with the Roche cobas HIV-1 reference assay. We determined accuracy to detect viraemia at the World Health Organization (WHO) failure threshold of 1000 copies/mL on all 3 assays, and 50 and 200 copies/mL on the Xpert assays. We assessed the agreement using Bland-Altman plots.

Results

We enrolled 140 participants (98 [70%] women, median age 37 years), who provided 189 paired samples at one or more timepoints. We tested 174 samples with the Xpert XC, 188 with the Xpert VL, and 128 with the m-PIMA. At 1000 copies/mL, sensitivity and specificity (95% confidence intervals) were 97% (82 to 100) and 98% (93 to 99) (Xpert XC), 100% (87 to 100) and 96% (91 to 98) (Xpert VL), and 92% (72 to 99) and 99% (93 to 100) (m-PIMA) respectively. At 50 copies/mL, sensitivity and specificity were 93% (81 to 98) and 96% (91 to 99) (Xpert XC), and 95% (84 to 99) and 95% (90 to 98) (Xpert VL) respectively. Mean bias was -0.10 (-0.54 to 0.34) log10 copies/mL (Xpert XC), 0.07 (-0.37 to 0.52) log10 copies/mL (Xpert VL), and -0.26 (-0.83 to 0.31) log10 copies/mL (m-PIMA).

Conclusions

In these South African clinics, the accuracy of all 3 assays was clinically acceptable to detect viraemia at the WHO failure threshold, whereas both Xpert assays were also accurate at detecting low-level viraemia.

SUBMITTER: Dorward J

PROVIDER: S-EPMC7613592 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, & m-PIMA HIV-1/2 Viral Load in South African Clinics.

Dorward Jienchi J Naidoo Jessica J Moodley Pravikrishnen P Sookrajh Yukteshwar Y Samsunder Natasha N Sayed Fathima F Naicker Nivashnee N Fanshawe Thomas T Drain Paul K PK Lessells Richard J RJ Hayward Gail G Butler Christopher C CC Garrett Nigel N

Journal of acquired immune deficiency syndromes (1999) 20220613 2

<h4>Background</h4>We aimed to evaluate the analytic performance of 3 rapid HIV viral load assays: the novel Xpert HIV-1 VL XC (Xpert XC), Xpert HIV-1 VL (Xpert VL), and m-PIMA HIV-1/2 VL (m-PIMA).<h4>Setting</h4>Two South African clinics.<h4>Methods</h4>We conducted a prospective diagnostic accuracy study. Site-laboratory technicians and nurses used the Xpert XC, Xpert VL, and m-PIMA to test plasma samples from people with HIV receiving antiretroviral therapy. We compared results with the Roche ...[more]

PMID: 36094486

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Project description:BackgroundWe examined the epidemiology and transmission potential of HIV population viral load (VL) in 12 sub-Saharan African countries.MethodsWe analyzed data from Population-based HIV Impact Assessments (PHIAs), large national household-based surveys conducted between 2015 and 2019 in Cameroon, Cote d'Ivoire, Eswatini, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe. Blood-based biomarkers included HIV serology, recency of HIV infection, and VL. We estimated the number of people living with HIV (PLHIV) with suppressed viral load (<1,000 HIV-1 RNA copies/mL) and with unsuppressed viral load (viremic), the prevalence of unsuppressed HIV (population viremia), sex-specific HIV transmission ratios (number female incident HIV-1 infections/number unsuppressed male PLHIV per 100 persons-years [PY] and vice versa) and examined correlations between a variety of VL metrics and incident HIV. Country sample sizes ranged from 10,016 (Eswatini) to 30,637 (Rwanda); estimates were weighted and restricted to participants 15 years and older.ResultsThe proportion of female PLHIV with viral suppression was higher than that among males in all countries, however, the number of unsuppressed females outnumbered that of unsuppressed males in all countries due to higher overall female HIV prevalence, with ratios ranging from 1.08 to 2.10 (median: 1.43). The spatial distribution of HIV seroprevalence, viremia prevalence, and number of unsuppressed adults often differed substantially within the same countries. The 1% and 5% of PLHIV with the highest VL on average accounted for 34% and 66%, respectively, of countries' total VL. HIV transmission ratios varied widely across countries and were higher for male-to-female (range: 2.3-28.3/100 PY) than for female-to-male transmission (range: 1.5-10.6/100 PY). In all countries mean log10 VL among unsuppressed males was higher than that among females. Correlations between VL measures and incident HIV varied, were weaker for VL metrics among females compared to males and were strongest for the number of unsuppressed PLHIV per 100 HIV-negative adults (R2 = 0.92).ConclusionsDespite higher proportions of viral suppression, female unsuppressed PLHIV outnumbered males in all countries examined. Unsuppressed male PLHIV have consistently higher VL and a higher risk of transmitting HIV than females. Just 5% of PLHIV account for almost two-thirds of countries' total VL. Population-level VL metrics help monitor the epidemic and highlight key programmatic gaps in these African countries.

Dataset Information

Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, & m-PIMA HIV-1/2 Viral Load in South African Clinics.

Background

Setting

Methods

Results

Conclusions

Publications

Diagnostic Accuracy of the Rapid Xpert HIV-1 Viral Load XC, Xpert HIV-1 Viral Load, & m-PIMA HIV-1/2 Viral Load in South African Clinics.

Similar Datasets

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