ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2020
Performance evaluation of four point-of-care HIV tests using unprocessed specimens.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 15 citations in OpenAlex.
- Translational opportunities in aptamer and nanobody lateral flow assays within the WHO REASSURED framework.Sensors & diagnostics · 2026Review
- Performance evaluation of a novel RapiSafe HIV Ag/Ab combi rapid test for the detection of HIV antigen and antibodies.Frontiers in cellular and infection microbiology · 2025Article
- Evaluation of a point-of-care rapid HIV antibody test with insights into acute HIV symptomatology in a population with low prevalence.Journal of clinical microbiology · 2024Article
- Unique Needs for the Implementation of Emergency Department Human Immunodeficiency Virus Screening in Adolescents.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2020Article
- Highlights From the 2019 HIV Diagnostics Conference: Optimizing Testing for HIV, STIs, and HCV.Sexually transmitted diseases · 2020Article
- Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT.JMIR research protocols · 2020Article
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundThe performance of recently approved point-of-care (POC) HIV tests should be assessed using unprocessed specimens.
objectiveTo evaluate the sensitivity and specificity of four POC HIV tests using whole blood (WB) and two using oral fluid (OF) among persons recruited from health clinics in Seattle, Washington, during September 2015-September 2017. STUDY
designParticipants were tested with the POC tests, additional plasma and serum were collected for laboratory testing, and participant- reported use of antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) was recorded. Participants testing negative on all tests could reenroll every 90 days. Specimens from persons previously diagnosed with HIV infection as well as from those who were newly diagnosed during the study were included in the sensitivity estimate. Sensitivity and specificity were calculated based on HIV status determined by laboratory testing.
resultsOf 1,256 visits, 179 were from persons with HIV infection; 120 of these were taking ART. Among 1,077 visits from participants not diagnosed with HIV, PrEP use was reported at 155 (14.4%) visits. Sensitivity was similar among POC WB tests (95.53%-97.21%; p>0.05). Among participants on ART, sensitivity was lower for the same test performed on OF compared to WB (p<0.003). Specificity was high for all tests (99.44%- 100.00%); we did not detect specificity differences with PrEP use.
conclusionsThese POC tests displayed relatively high sensitivity and specificity using unprocessed specimens, suggesting their effectiveness in identifying HIV infections whenever laboratory-based testing is not feasible. Nonetheless, clients with recent risk should retest to rule out the possibility of a false-negative result.
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