10.7.3What are the diagnostic tests available for detection of HIV infection and how do they compare in terms of specificity, sensitivity and cost-effectiveness?

StudyRef.PopulationInterventionOutcomesResultsCommentsStudy typeEL
Balano, 1998614Rapid HIV screening during labourPerformance of rapid HIV 1 antibody testingSensitivity 99.9%
Specificity 99.6%
Positive predictive value exceeds 50% only when prevalence of HIV 1 exceeds 0.5%
Letter
This paper only reported the performance of this test, i.e. did not investigate the test’s performance itself
PHLS AIDS Diagnosis Working Group, 1992415HIV testing algorithmInitial assay (EIA or rapid tests). If reaction is positive, further testing with different assays (two). If both confirmatory tests are nonreactive, issue negative report. If confirmatory tests are reactive, one more test with a new specimen should be obtained to ensure no procedural errors have occurredAvailable EIAs or rapid tests have similar and adequate sensitivity to be used singly to generate a negative report (unless HIV-2 assay is also needed)
HIV culture and tests for p24 antigen are not of much value in diagnostic testing, as they may be insensitive, non-specific and expensive tests
In a low prevalence population such as the UK, high specificity and reasonable sensitivity are importantReport from PHLS AIDS Diagnosis Working GroupIV
Postma et al., 1999615Performance of ELISA as initial test for HIV as specified for use in cost effectiveness modelSensitivity 100%
Specificity 99.9%
Unclear, but these values seem to be as reported from the manufacturer
Van Doornum, 1998414Serum specimens from 31,232 pregnant women in Amsterdam between 1988 and 1995Two ELISA approach (with membrane spot assay to discriminate between infection with HIV-1 or HIV-2 ) vs. Western blot analysisEvaluation of confirmatory strategy of two-ELISA approach and resolution of indeterminate results with NASBA and SIA42 sera that were available for analysis which gave positive or borderline results by ELISA and indeterminate or negative results by Western blot
All initially reactive samples (tested by EIA) were retested by a second ELISA (based on a different principle) and the initial screening assay
Confirmation of reactivity with a second EIA, enhanced with a membrane spot assay to discriminate between HIV-1 and HIV-2, was necessary and useful for endorsing a negative result and confirming possible cases of HIV 2 infection
The importance of requesting a new specimen upon reactive confirmation results to ensure against procedural errors was also demonstrated.
EV3
Samson and King, 1998413Literature review to compile evidence-based guidelines on HIV screening in pregnancyRecommendations on HIV testing in pregnant womenThird generation EIA kits have sensitivity 99.4%–100% and specificity 99–100%
Combined EIA and Western blot protocol has sensitivity 99% and specificity 99.99%
These are guidelines for Canada

From: Evidence tables

Cover of Antenatal Care
Antenatal Care: Routine Care for the Healthy Pregnant Woman.
NICE Clinical Guidelines, No. 62.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2008 Mar.
Copyright © 2008, National Collaborating Centre for Women’s and Children’s Health.

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