ArticlePloS one2018
Performance and usability evaluation of the INSTI HIV self-test in Kenya for qualitative detection of antibodies to HIV.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Article
- Accuracy of and preferences for blood-based versus oral-fluid-based HIV self-testing in Malawi: a cross-sectional study.BMC infectious diseases · 2024Article
- Impact of HIV self-testing for oral pre-exposure prophylaxis scale-up on drug resistance and HIV outcomes in western Kenya: a modelling study.The lancet. HIV · 2024Article
- Seroprevalence and risk factors associated with hepatitis C: a cross-sectional study of persons who inject drugs in Puerto Rico, 2018.BMC public health · 2023Article
- Acceptability, feasibility, and accuracy of blood-based HIV self-testing: A cross-sectional study in Ho Chi Minh City, Vietnam.PLOS global public health · 2023Article
- HIV self-testing in the real world is acceptable for many: post-test participant feedback from the GetaKit study in Ottawa, Canada.Journal of research in nursing : JRN · 2022Article
- 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
- Values and preferences for hepatitis C self-testing among the general population and healthcare workers in Rwanda.BMC infectious diseases · 2021Article
- Acceptability and usability of HIV self-tests in two European countries: findings from surveys of clients at non-governmental organisations in Lithuania and Italy.BMC infectious diseases · 2021Article
- An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada.BMC public health · 2021Article
- A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa.Diagnostics (Basel, Switzerland) · 2021Article
- Challenges of HIV Self-Test Distribution for Index Testing When HIV Status Disclosure Is Low: Preliminary Results of a Qualitative Study in Bamako (Mali) as Part of the ATLAS Project.Frontiers in public health · 2021Article
- Implementation outcomes of HIV self-testing in low- and middle- income countries: A scoping review.PloS one · 2021Article
- SMARTtest: A Smartphone App to Facilitate HIV and Syphilis Self- and Partner-Testing, Interpretation of Results, and Linkage to Care.AIDS and behavior · 2020Article
- Evaluation of a mobile application to support HIV self-testing in Johannesburg, South Africa.Southern African journal of HIV medicine · 2020Article
- Usability assessment of seven HIV self-test devices conducted with lay-users in Johannesburg, South Africa.PloS one · 2020Article
- Bringing HIV Self-Testing to Scale in the United States: a Review of Challenges, Potential Solutions, and Future Opportunities.Journal of clinical microbiology · 2019Review
- Field performance of the INSTI HIV-1/-2 antibody test in two South African antenatal clinics.Journal of medical virology · 2019Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHIV testing is often undermined by lack of confidentiality, stigma, shortage of counselors and long distances to testing centers. Self-testing has the potential to circumvent these constraints.
objectiveTo determine the performance and usability characteristics of the INSTI® HIV-1/HIV-2 Self-Test.
methodsThe performance evaluation was a cross sectional study and the usability a mixed methods study. For method comparison, Bioelisa HIV-1+2 Ag/Ab test was used as the reference test. When the test results were discrepant, results from Alere Determine™ HIV-1/2 and First Response HIV-1-2 Antibody tests were used for confirmation of status.
resultsSensitivity of the INSTI HIV Self-Test was 98.99% (95% CI 96.05-99.75%), and specificity 98.15% (95% CI 95.63-99.23%). The concordance was therefore 97.27%. A total of 354 participants took part in the usability study. Of those, 343 (98.00%) found instructions for use easy to follow, 330 (94.29%) found the finger prick device easy to use, 303 (86.57%) were confident while performing the test, 342 (97.71%) felt result interpretation was easy, while 304 (86.86%) declared results within the recommended five minutes. Three hundred and forty two (342, 97.71%) were willing to use the test again while 344 (98.29%) would recommend the kit to a sexual partner. None of the 350 participants quit the process at any stage. Three hundred and eighteen (318, 91.12%) participants felt the test needed no further improvement. All 91 lay users correctly identified cartridges that showed positive, negative and invalid results. Only 31 (34.07%) participants correctly identified weak positive dummy test results.
conclusionThe excellent performance and usability characteristics of INSTI HIV-1/HIV-2 self-test make the kit a viable option for HIV self-testing. To improve the identification of weak positive results, the manufacturer should indicate on the IFU that even a faint test spot should be interpreted as positive.
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