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Reliability of HIV rapid diagnostic tests for self-testing compared with testing by health-care workers: a systematic review and meta-analysis

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Figueroa, Carmen, Johnson, Cheryl, Ford, Nathan, Sands, Anita, Dalal, Shona, Meurant, Robyn, Prat, Irena, Hatzold, Karin +2 more·2018·The Lancet HIV
DOI 10.1016/s2352-3018(18)30044-4PMC PMC5986793
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Abstract

Background The ability of individuals to use HIV self-tests correctly is debated. To inform the 2016 WHO recommendation on HIV self-testing, we assessed the reliability and performance of HIV rapid diagnostic tests when used by self-testers. Methods In this systematic review and meta-analysis, we searched PubMed, PopLine, and Embase, conference abstracts, and additional grey literature between Jan 1, 1995, and April 30, 2016, for observational and experimental studies reporting on HIV self-testing performance. We excluded studies evaluating home specimen collection because patients did not interpret their own test results. We extracted data independently, using standardised extraction forms. Outcomes of interest were agreement between self-testers and health-care workers, sensitivity, and specificity. We calculated κ to establish the level of agreement and pooled κ estimates using a random-effects model, by approach (directly assisted or unassisted) and type of specimen (blood or oral fluid). We examined heterogeneity with the I 2 statistic. Findings 25 studies met inclusion criteria (22 to 5662 participants). Quality assessment with QUADAS-2 showed studies had low risk of bias and incomplete reporting in accordance with the STARD checklist. Raw proportion of agreement ranged from 85·4% to 100%, and reported κ ranged from fair (κ 0·277, p<0·001) to almost perfect (κ 0·99, n=25). Pooled κ suggested almost perfect agreement for both types of approaches (directly assisted 0·98, 95% CI 0·96–0·99 and unassisted 0·97, 0·96–0·98; I 2 =34·5%, 0–97·8). Excluding two outliers, sensitivity and specificity was higher for blood-based rapid diagnostic tests (4/16) compared with oral fluid rapid diagnostic tests (13/16). The most common error that affected test performance was incorrect specimen collection (oral swab or finger prick). Study limitations included the use of different reference standards and no disaggregation of results by individuals taking antiretrovirals. Interpretation Self-testers can reliably and accurately do HIV rapid diagnostic tests, as compared with trained health-care workers. Errors in performance might be reduced through the improvement of rapid diagnostic tests for self-testing, particularly to make sample collection easier and to simplify instructions for use. Funding The Bill & Melinda Gates Foundation and Unitaid.

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Authors
Figueroa, C., Johnson, C., Ford, N., Sands, A., Dalal, S., Meurant, R., Prat, I., Hatzold, K., Urassa, W., & Baggaley, R.
Affiliations
  • World Health Organization (CH)
  • London School of Hygiene & Tropical Medicine (GB)
Corresponding author
Figueroa, Carmen
ORCID
Venue
The Lancet HIV
Publisher
Elsevier BV
Published
2018-06
Volume
5
Issue
6
Pages
e277-e290
ISSN
2352-3018 (ISSN-L)
DOI
10.1016/s2352-3018(18)30044-4
PMC
PMC5986793
OpenAlex
W2799484760
Cited by
226
References
1
Citations by year
2026: 14 · 2025: 20 · 2024: 41 · 2023: 25 · 2022: 26 · 2021: 33 · 2020: 34 · 2019: 20 · 2018: 13
FWCI
3.67
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet HIV (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Funders
Bill and Melinda Gates Foundation (PO#10140-0-600)
Topics
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 detection and testing
  • Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords
HIV self-testing, rapid HIV testing, test reliability, sensitivity and specificity, blood testing
MeSH terms
Point-of-Care Testing, Diagnostic Tests, Routine, Humans, Self Care, Sensitivity and Specificity, Serologic Tests, Reproducibility of Results, HIV Infections

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