False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes.

Shanks, Leslie; Klarkowski, Derryck; O'Brien, Daniel P.

doi:10.1371/journal.pone.0059906

Cited by 113HIV/AIDS Research and InterventionsClinical Laboratory Practices and Quality ControlHIV Research and Treatment

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False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes.

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Shanks, Leslie, Klarkowski, Derryck, O'Brien, Daniel P.·2013·PLoS ONE

DOI 10.1371/journal.pone.0059906PMC PMC3603939

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Abstract

BACKGROUND: Access to HIV diagnosis is life-saving; however the use of rapid diagnostic tests in combination is vulnerable to wrongly diagnosing HIV infection when both screening tests give a false positive result. Misclassification of HIV patients can also occur due to poor quality control, administrative errors and lack of supervision and training of staff. Médecins Sans Frontières discovered in 2004 that HIV negative individuals were enrolled in some HIV programmes. This paper describes the result of an audit of three sites to review testing practices, implement improved testing algorithms and offer re-testing to clients enrolled in the HIV clinic. FINDINGS: In the Democratic Republic of Congo (DRC), Burundi and Ethiopia patients were identified for HIV retesting. In total, 44 false-positive patients were identified in HIV programmes in DRC, two in Burundi and seven in Ethiopia. Some of those identified had been abandoned by partners or started on anti-retroviral therapy or prophylaxis. Despite potential damage to programme reputations, no impact in terms of testing uptake occurred with mean monthly testing volumes stable after introduction of re-testing. In order to prevent the problem, training, supervision and quality control of testing procedures were strengthened. A simple and feasible confirmation test was added to the test algorithm. Prevalence of false positives after introducing the changes varied from zero percent (95% CI 0%-8.2%) to 10.3 percent (95% CI: 7.2%-14.1%) in Burundi and DRC respectively. CONCLUSION: False HIV diagnoses were found in a variety of programme settings and had devastating individual consequences. We re-tested individuals in our programmes while instituting improved testing procedures without a negative impact on test uptake. Considering the importance of correct diagnosis to the individual, as well as the resources needed to care for someone with HIV, it is critical to ensure that all patients registered in HIV programmes are accurately diagnosed.

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The high rate of RDT biological false positives is not unexpected in a low transmission setting because these tests are optimized for sensitivity at the expense of specificity.
“This high rate of RDT biological false positives is not unexpected in a low transmission setting as these tests are optimized for sensitivity at the expense of specificity 20.”
From Audit of antenatal screening for syphilis and HIV in migrant and refugee women on the Thai-Myanmar border: a descriptive study (2015) · cites this paper as [20]

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Authors: Shanks, L., Klarkowski, D., & O'Brien, D. P.
Affiliations: Médecins Sans Frontières (NL)
The Royal Melbourne Hospital (AU)
Corresponding author: Shanks, Leslie
ORCID: O'Brien, Daniel P.
Venue: PLoS ONE
Publisher: Public Library of Science (PLoS)
Published: 2013-03-20
Volume: 8
Issue: 3
Pages: e59906
ISSN: 1932-6203 (ISSN-L)
DOI: 10.1371/journal.pone.0059906
PMC: PMC3603939
OpenAlex: W1998715001
Cited by: 110
References: 16
Citations by year: 2026: 2 · 2025: 5 · 2024: 7 · 2023: 5 · 2022: 7 · 2021: 10 · 2020: 5 · 2019: 6 · 2018: 8 · 2017: 19 · 2016: 8 · 2015: 18 · 2014: 6 · 2013: 4
FWCI: 8.72
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
creativecommons.org/licenses/by/4.0/ (unspecified)
Locations: PLoS ONE (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Minerva Access (University of Melbourne) (submittedVersion, cc-by)
DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Medecins Sans Frontieres Field Research (Medecins Sans Frontieres) (submittedVersion, other-oa)
Figshare (submittedVersion, cc-by)
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords: rapid diagnostic tests, HIV retesting, confirmatory testing, HIV testing algorithms, Médecins Sans Frontières, resource-limited settings, HIV testing uptake, Democratic Republic of the Congo, Burundi, Ethiopia
MeSH terms: Algorithms, Burundi, Ethiopia, False Positive Reactions, Humans, Mass Screening, Sensitivity and Specificity, Democratic Republic of the Congo, Reproducibility of Results, HIV Infections, Prevalence, Molecular Diagnostic Techniques, Clinical Audit

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False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes.

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