BMJ  2007;335:188 (28 July), doi:10.1136/bmj.39210.582801.BE (published 1 June 2007)

Research

Limitations of rapid HIV-1 tests during screening for trials in Uganda: diagnostic test accuracy study

¹ Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD 21205, USA, ² Johns Hopkins University, Bloomberg School of Public Health, Baltimore and Mailman School of Public Health, Columbia University, NY, USA, ³ Rakai Health Sciences Program, Uganda Virus Research Institute, Entebbe, Uganda, ⁴ Makerere University, Institute of Public Health, Kampala, Uganda, ⁵ National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Entebbe, Uganda, ⁶ School of Medicine, Makerere University, Uganda

Objective To evaluate the limitations of rapid tests for HIV-1.

Design Diagnostic test accuracy study.

Setting Rural Rakai, Uganda.

Participants 1517 males aged 15-49 screened for trials of circumcision for HIV prevention.

Main outcome measures Sensitivity, specificity, negative predictive values, and positive predictive values of an algorithm using three rapid tests for HIV, compared with the results of enzyme immunoassay and western blotting as the optimal methods.

Results Rapid test results were evaluated by enzyme immunoassay and western blotting. Sensitivity was 97.7%. Among 639 samples where the strength of positive bands was coded if the sample showed positivity for HIV, the algorithm had low specificity (94.1%) and a low positive predictive value (74.0%). Exclusion of 37 samples (5.8%) with a weak positive band improved the specificity (99.6%) and positive predictive value (97.7%).

Conclusion Weak positive bands on rapid tests for HIV should be confirmed by enzyme immunoassay and western blotting before disclosing the diagnosis. Programmes using rapid tests routinely should use standard serological assays for quality control.

Trial registration Clinical Trials NCT00425984 [ClinicalTrials.gov] .

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