ArticleJournal of clinical virology : the official publication of the Pan American Society for Clinical Virology2017
Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections.
Article in Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed.
- Cost-Effectiveness of the I'm Ready HIV Self-Testing Programme Among High-Risk Populations in Canada.Journal of the International AIDS Society · 2026Article
- A handheld HIV detection platform using paper-based sample preparation and real-time isothermal amplification.Microsystems & nanoengineering · 2024Article
- Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening.Journal of medical virology · 2024Article
- 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
- Rapid tests should be used with caution for HIV-1 primary infection screening.Medical microbiology and immunology · 2024Article
- Findings from a novel and scalable community-based HIV testing approach to reduce the time required to complete point-of-care HIV testing in South Africa.BMC health services research · 2021Article
- Multi-volume hemacytometer.Scientific reports · 2021Article
- Aspects of Point-of-Care Diagnostics for Personalized Health Wellness.International journal of nanomedicine · 2021Review
- Performance evaluation of the MedMira reveal G4 LAB S/P and POC HIV antibody rapid screening tests using plasma and whole blood specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Could HIV-1 RNA Testing be an Option as the Second Step in the HIV Diagnostic Algorithm?Sexually transmitted diseases · 2020Article
- Performance evaluation of four point-of-care HIV tests using unprocessed specimens.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2020Article
- Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT.JMIR research protocols · 2020Article
- Field performance of the INSTI HIV-1/-2 antibody test in two South African antenatal clinics.Journal of medical virology · 2019Article
- Field evaluation of a dual rapid Human Immunodeficiency Virus and treponemal syphilis rapid test in community-based clinics in Los Angeles and New York.Diagnostic microbiology and infectious disease · 2019Article
- Performance and usability evaluation of the INSTI HIV self-test in Kenya for qualitative detection of antibodies to HIV.PloS one · 2018Article
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Authors and funding
7 authors.
Funding
Abstract
backgroundThe flow-through INSTI™ HIV-1/HIV-2 Rapid Antibody (INSTI) test is a 60s FDA-approved test for HIV-1 and HIV-2 antibody testing using whole blood and plasma.
objectiveWe evaluated the performance of INSTI using plasma and simulated whole blood specimens. STUDY
designINSTI's performance in plasma specimens from commercial seroconversion panels was assessed by estimating the relative sensitivity using a 50% cumulative frequency analysis and by comparing its performance with other FDA-approved rapid tests (RTs). INSTI was further evaluated using 320 HIV-1 plasma specimens collected during a cross-sectional study and with 107 HIV-1 and 24 HIV-2 simulated whole blood specimens. Sensitivity and specificity were calculated using 615 known HIV-1 group M/O and 80 HIV-2 (Western blot (WB)-positive), and 497 HIV-negative plasma specimens, respectively.
resultsIn HIV-1 seroconversion panels, INSTI became reactive 9days before a positive WB. When compared to FDA-approved antibody-based lateral flow RTs, INSTI detected significantly more early infections. Among HIV-1-infected cross-sectional plasma samples, INSTI detected 23 (27%) of 85 Architect-positive/Multispot-negative or indeterminate specimens. For plasma specimens, the sensitivity was 99.84% for HIV-1 and 100% for HIV-2, and the specificity was 99.80%. Using simulated whole blood from seroconverters, INSTI performed similarly to plasma.
conclusionsINSTI performed significantly better than antibody-based lateral flow RTs during early stages of seroconversion. Sensitivity and specificity were within the manufacturer's reported ranges. Considering the observed test performance and the almost immediate results, INSTI is an accurate option to detect HIV-1/HIV-2 antibodies in point-of-care settings where lab testing is not feasible.
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