Performance of serological and molecular tests within acute HIV infection

Fransen, Katrien; Baetselier, Irith De; Rammutla, Elizabeth; Ahmed, Khatija; Owino, Frederick; Agingu, Walter; Venter, Gustav; Deese, Jennifer; Damme, Lut Van; Crucitti, Tania

doi:10.1016/j.jcv.2017.03.010

Cited by 8 publications

(8 citation statements)

References 11 publications

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“…Specific analysis of p24Ag detection showed that this RST appears to be well adapted to various strains (except HIV-2, in accordance with the manufacturer's instructions), although we did not evaluate analytical sensitivity. Our data are in accordance with recent results showing that this test can shorten serological windows [ [47] , [48] , [49] ]. Nonetheless, this needs to be confirmed on a larger scale and compared to other 4G RSTs, such as the WHO prequalified SD Bioline test, recently evaluated using a serum matrix [ 49 , 50 ].…”

Section: Discussionsupporting

confidence: 93%

“…Our data are in accordance with recent results showing that this test can shorten serological windows [ [47] , [48] , [49] ]. Nonetheless, this needs to be confirmed on a larger scale and compared to other 4G RSTs, such as the WHO prequalified SD Bioline test, recently evaluated using a serum matrix [ 49 , 50 ]. Here, we performed a comparison with the BioTechMed non-CE-marked/FDA-approved/WHO prequalified test, sold as a 4G SF by a web-based vendor; finally, this test detected fewer PHI samples than three 3G tests (29 versus 30, 31, and 36) and none of the p24Ag samples reconstituted from viral supernatants.…”

Section: Discussionsupporting

confidence: 93%

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HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors

et al. 2018

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BackgroundRapid tests for HIV testing are essential tools to achieve the 90-90-90 target of the World Health Organization. Many tests are available, some directly from websites. Evaluation of the performance of rapid tests, under close to real-life usage, is therefore needed to ensure accurate diagnosis in the context of the recommendation for their more widespread use.MethodNine third- (3G) or fourth-generation (4G) rapid screening tests or self-tests (two bought on websites), were evaluated on an extensive panel of 200 HIV-negative and 312 HIV-positive samples, representative of a wide variety of clinical situations and HIV genetic diversity. A whole blood reconstitution protocol was designed to simulate real-life usage of these tests in community-based and private settings.FindingsThe specificity was high (98.5–100%) and sensitivity excellent (100%) for samples from patients chronically infected with the pandemic strains. The performance for infrequent situations with a major epidemiological and clinical impact, such as infection with divergent viruses or primary infection, was highly variable, depending on the test. One of the two 4G tests allowed detection of additional positive samples from early stages of infection, whereas the second (sold as a 4G test on a website) corresponded in reality to a 3G test.InterpretationOur study showed that not all tests are equal for the detection of major HIV variants or early stages of HIV infection; adding the detection of specific p24Ag improved the latter point. This study also showed, for the first time, that buying through web-based vendors can be risky, due to the varying performance of the tests and questionable sales practices. Our results are of particular importance in the context of the increasing use of rapid tests in an “outside laboratory” settings.FundSanté Publique France, COREVIH – Normandie, and Rouen University Hospital.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 93%

HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors

et al. 2018

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“…To our knowledge, this is one of the few studies evaluating the SD Combo assay using serum samples. Fransen et al (2016) studied the performance of the test on 35 acute infection samples and showed that the SD Bioline had sensitivity of 29.4% (95% CI 15.1–47.5) and specificity 100% (89.9–100)[ 13 ]. In this evaluation the SD Combo showed also low performance in acute infection samples (sensitivity = 61.5%, 95% CI 31.6%– 86.1%).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection

Stafylis

Klausner

2017

PLoS ONE

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BackgroundFourth generation assays detect simultaneously antibodies for HIV and the p24 antigen, identifying HIV infection earlier than previous generation tests. Previous studies have shown that the Alere Determine HIV-1/2 Combo has lower than anticipated performance in detecting antibodies for HIV and the p24 antigen. Furthermore, there are currently very few studies evaluating the performance of Standard Diagnostics BIOLINE HIV Ag/Ab Combo.ObjectiveTo evaluate the performance of the Alere Determine HIV-1/2 Combo and the Standard Diagnostics BIOLINE HIV Ag/Ab Combo in a panel of frozen serum samples.Study designThe testing panel included 133 previously frozen serum specimens from the UCLA Clinical Microbiology & Immunoserology laboratory. Reference testing included testing for HIV antibodies by a 3rd generation enzyme immunoassay followed by HIV RNA detection. Antibody negative and RNA positive sera were also tested by a laboratory 4th generation HIV Ab/Ag enzyme immunoassay.ResultsReference testing yielded 97 positives for HIV infection and 36 negative samples. Sensitivity of the Alere test was 95% (88–98%), while the SD Bioline sensitivity was 91% (83–96%). Both assays showed 100% (90–100%) specificity. No indeterminate or invalid results were recorded. Among 13 samples with acute infection (HIV RNA positive, HIV antibody negative), 12 were found positive by the first assay and 8 by the second. The antigen component of the Alere assay detected 10 acute samples, while the SD Bioline assay detected only one.ConclusionsBoth rapid assays showed very good overall performance in detecting HIV infection in frozen serum samples, but further improvements are required to improve the performance in acute infection.

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“…However, the rapid combination antibody/antigen tests such as the Alere HIV 1/2 Combo or SD Bioline HIV Ag/Ab Combo has been found to have reduced sensitivity in acute infection, although they may still increase the number of individuals with acute and early infections detected over and above what would be detected by third-generation testing alone. [ 11 – 13 ]…”

Section: Introductionmentioning

confidence: 99%

The accuracy of HIV rapid testing in integrated bio-behavioral surveys of men who have sex with men across 5 Provinces in South Africa

et al. 2017

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We describe the accuracy of serial rapid HIV testing among men who have sex with men (MSM) in South Africa and discuss the implications for HIV testing and prevention.This was a cross-sectional survey conducted at five stand-alone facilities from five provinces.Demographic, behavioral, and clinical data were collected. Dried blood spots were obtained for HIV-related testing. Participants were offered rapid HIV testing using 2 rapid diagnostic tests (RDTs) in series. In the laboratory, reference HIV testing was conducted using a third-generation enzyme immunoassay (EIA) and a fourth-generation EIA as confirmatory. Accuracy, sensitivity, specificity, positive predictive value, negative predictive value, false-positive, and false-negative rates were determined.Between August 2015 and July 2016, 2503 participants were enrolled. Of these, 2343 were tested by RDT on site with a further 2137 (91.2%) having definitive results on both RDT and EIA. Sensitivity, specificity, positive predictive value, negative predictive value, false-positive rates, and false-negative rates were 92.6% [95% confidence interval (95% CI) 89.6–94.8], 99.4% (95% CI 98.9–99.7), 97.4% (95% CI 95.2–98.6), 98.3% (95% CI 97.6–98.8), 0.6% (95% CI 0.3–1.1), and 7.4% (95% CI 5.2–10.4), respectively. False negatives were similar to true positives with respect to virological profiles.Overall accuracy of the RDT algorithm was high, but sensitivity was lower than expected. Post-HIV test counseling should include discussions of possible false-negative results and the need for retesting among HIV negatives.

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Performance of serological and molecular tests within acute HIV infection

Cited by 8 publications

References 11 publications

HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors

HIV rapid screening tests and self-tests: Be aware of differences in performance and cautious of vendors

Evaluation of two 4th generation point-of-care assays for the detection of Human Immunodeficiency Virus infection

The accuracy of HIV rapid testing in integrated bio-behavioral surveys of men who have sex with men across 5 Provinces in South Africa

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