Frequency of false positive rapid HIV serologic tests in African men and women receiving PrEP for HIV prevention

Implications for programmatic roll-out of biomedical interventions

Patrick Ndase, Connie Celum, Lara Kidoguchi, Allan Ronald, Kenneth Fife, Elizabeth Bukusi, Deborah Donnell, Jared M. Baeten

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background: Rapid HIV assays are the mainstay of HIV testing globally. Delivery of effective biomedical HIV prevention strategies such as antiretroviral pre-exposure prophylaxis (PrEP) requires periodic HIV testing. Because rapid tests have high (>95%) but imperfect specificity, they are expected to generate some false positive results. Methods: We assessed the frequency of true and false positive rapid results in the Partners PrEP Study, a randomized, placebo-controlled trial of PrEP. HIV testing was performed monthly using 2 rapid tests done in parallel with HIV enzyme immunoassay (EIA) confirmation following all positive rapid tests. Results: A total of 99,009 monthly HIV tests were performed; 98,743 (99.7%) were dual-rapid HIV negative. Of the 266 visits with ≥1 positive rapid result, 99 (37.2%) had confirmatory positive EIA results (true positives), 155 (58.3%) had negative EIA results (false positives), and 12 (4.5%) had discordant EIA results. In the active PrEP arms, over two-thirds of visits with positive rapid test results were false positive results (69.2%, 110 of 159), although false positive results occurred at <1% (110/65,945) of total visits. Conclusions When HIV prevalence or incidence is low due to effective HIV prevention interventions, rapid HIV tests result in a high number of false relative to true positive results, although the absolute number of false results will be low. Program roll-out for effective interventions should plan for quality assurance of HIV testing, mechanisms for confirmatory HIV testing, and counseling strategies for persons with positive rapid test results.

Original languageEnglish
Article numbere0123005
JournalPLoS One
Volume10
Issue number4
DOIs
StatePublished - Apr 17 2015

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Serologic Tests
immunologic techniques
disease control
HIV
Testing
Enzymes
enzyme immunoassays
testing
Immunoenzyme Techniques
Quality assurance
Assays
Pre-Exposure Prophylaxis
counseling
placebos
quality control
Counseling
Randomized Controlled Trials
Placebos

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

Frequency of false positive rapid HIV serologic tests in African men and women receiving PrEP for HIV prevention : Implications for programmatic roll-out of biomedical interventions. / Ndase, Patrick; Celum, Connie; Kidoguchi, Lara; Ronald, Allan; Fife, Kenneth; Bukusi, Elizabeth; Donnell, Deborah; Baeten, Jared M.

In: PLoS One, Vol. 10, No. 4, e0123005, 17.04.2015.

Research output: Contribution to journalArticle

Ndase, Patrick ; Celum, Connie ; Kidoguchi, Lara ; Ronald, Allan ; Fife, Kenneth ; Bukusi, Elizabeth ; Donnell, Deborah ; Baeten, Jared M. / Frequency of false positive rapid HIV serologic tests in African men and women receiving PrEP for HIV prevention : Implications for programmatic roll-out of biomedical interventions. In: PLoS One. 2015 ; Vol. 10, No. 4.
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abstract = "Background: Rapid HIV assays are the mainstay of HIV testing globally. Delivery of effective biomedical HIV prevention strategies such as antiretroviral pre-exposure prophylaxis (PrEP) requires periodic HIV testing. Because rapid tests have high (>95{\%}) but imperfect specificity, they are expected to generate some false positive results. Methods: We assessed the frequency of true and false positive rapid results in the Partners PrEP Study, a randomized, placebo-controlled trial of PrEP. HIV testing was performed monthly using 2 rapid tests done in parallel with HIV enzyme immunoassay (EIA) confirmation following all positive rapid tests. Results: A total of 99,009 monthly HIV tests were performed; 98,743 (99.7{\%}) were dual-rapid HIV negative. Of the 266 visits with ≥1 positive rapid result, 99 (37.2{\%}) had confirmatory positive EIA results (true positives), 155 (58.3{\%}) had negative EIA results (false positives), and 12 (4.5{\%}) had discordant EIA results. In the active PrEP arms, over two-thirds of visits with positive rapid test results were false positive results (69.2{\%}, 110 of 159), although false positive results occurred at <1{\%} (110/65,945) of total visits. Conclusions When HIV prevalence or incidence is low due to effective HIV prevention interventions, rapid HIV tests result in a high number of false relative to true positive results, although the absolute number of false results will be low. Program roll-out for effective interventions should plan for quality assurance of HIV testing, mechanisms for confirmatory HIV testing, and counseling strategies for persons with positive rapid test results.",
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