Acute Dengue Fever Causes False-Positive Reactivity in OraQuick Rapid HIV-1/2 Antibody Test

Mao, Alice R.; Obi-Gwacham, Chidera; Hill, Tamsey; Ryan, Catherine; Hendricks, Arthur; McKellar, Mehri

doi:10.1097/qai.0b013e3181f5b291

Cited by 6 publications

(3 citation statements)

References 7 publications

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“…There are few studies that address the cost of oral based testing in the field; however, the slow uptake of oral HIV testing by resource constrained countries may be due to the cost per test, which is higher than most blood based tests [ 14 ]. Moreover, oral fluid based HIV testing performance and sensitivity in the developing countries [ 15 - 20 ] and cross reactivity with other infections like dengue fever [ 21 ] are still being published.…”

Section: Introductionmentioning

confidence: 99%

Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia

et al. 2012

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BackgroundZambia’s national HIV testing algorithm specifies use of two rapid blood based antibody assays, Determine®HIV-1/2 (Inverness Medical) and if positive then Uni-GoldTM Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick® ADVANCE® Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick®.MethodsThis was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick® test using oral fluid versus two blood-based rapid HIV tests, Determine® and Uni-GoldTM. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine® and if positive, then Uni-GoldTM (Determine®/Uni-GoldTM); based on current algorithm, 2) Determine® and if positive, then OraQuick® (Determine®/OraQuick®), 3) OraQuick® and if positive, then Determine® (OraQuick®/Determine®), 4) OraQuick® and if positive, then Uni-GoldTM (OraQuick®/Uni-GoldTM). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1–30%.Results4,458 participants received both a Determine® and OraQuick® test. The sensitivity and specificity of the OraQuick® test were 98.7 (95%CI, 97.5–99.4) and 99.8 (95%CI, 99.6–99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine®/Uni-GoldTM, Determine®/OraQuick®, OraQuick®/Determine®, and OraQuick®/Uni-GoldTM, respectively, for an HIV prevalence of 15%.ConclusionsAn alternative HIV testing algorithm could include OraQuick® test which had a high sensitivity and specificity. The current Determine®/Uni-GoldTM testing algorithm is the least expensive when compared to Determine®/OraQuick®, OraQuick®/Determine®, and OraQuick®/Uni-GoldTM in the Zambian setting. From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.

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Section: Introductionmentioning

confidence: 99%

Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia

et al. 2012

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“…More work is needed to develop fully comprehensive external quality assurance (EQA) systems for oral fluid RDTs. False-positive results have been described for OFTs, particularly in the context of pregnancy and concomitant infections [ 12 , 13 ]. With respect to sensitivity, subsets where oral-based RDTs should be used with caution because of reports of lower than expected sensitivity [ 14 ] are patients at high risk of acute HIV infection [ 15 ] and those established on ART.…”

Section: Discussionmentioning

confidence: 99%

Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

et al. 2016

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ObjectivesTo evaluate the effect of storing commonly used rapid diagnostic tests above manufacturer-recommended temperature (at 37°C), and the accuracy of delayed reading of oral fluid kits with relevance to HIV self-testing programmes.DesignA quality assurance study of OraQuick (OraSure), Determine HIV 1/2™ (Alere) and Uni-Gold™ (Recombigen®).MethodsConsecutive adults (≥18y) attending Ndirande Health Centre in urban Blantyre, Malawi in January to April 2012 underwent HIV testing with two of each of the three rapid diagnostic test kits stored for 28 days at either 18°C (optimally-stored) or at 37°C (pre-incubated). Used OraQuick test kits were stored in a laboratory for delayed day 1 and subsequent monthly re-reading was undertaken for one year.ResultsOf 378 individuals who underwent parallel testing, 5 (1.3%) were dropped from the final analysis due to discordant or missing reference standard results (optimally-stored Determine and Uni-Gold). Compared to the diagnostic reference standard, OraQuick had a sensitivity of 97.2% (95% CI: 93.6–99.6). There were 7 false negative results among all test kits stored at 37°C and three false negatives among optimally stored kits. Excellent agreement between pre-incubated tests and optimally-stored tests with Kappa values of 1.00 for Determine and Uni-Gold; and 0.97 (95% CI: 0.95; 1.00) for OraQuick were observed. There was high visual stability on re-reading of OraQuick, with only 1/375 pre-incubated and 1/371 optimally-stored OraQuick kits changing from the initial result over 12 months.ConclusionErroneous results observed during HIV testing in low income settings are likely to be due to factors other than suboptimal storage conditions. Re-reading returned OraQuick kits may offer a convenient and accurate quality assurance approach, including in HIV self-testing programmes.

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“…19 Reports from tropical countries with rapid fingerstick HIV test screening programs show false positives in people with malaria, sleeping sickness, dengue fever, and schistosomiasis. 20 –23 In addition, false positives have been found among pregnant women (younger and nulliparous women were more likely to be false positives) and a patient with angioimmunoblastic T-cell lymphoma. 24,25…”

Section: Introductionmentioning

confidence: 99%

Factors Associated with False-Positive Results from Fingerstick OraQuick ADVANCE Rapid HIV 1/2 Antibody Test

Rifkin

Owens

Greenwald

2012

Journal of the International Association of Physicians in AIDS

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Acute Dengue Fever Causes False-Positive Reactivity in OraQuick Rapid HIV-1/2 Antibody Test

Cited by 6 publications

References 7 publications

Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia

Field comparison of OraQuick® ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia

Initial Accuracy of HIV Rapid Test Kits Stored in Suboptimal Conditions and Validity of Delayed Reading of Oral Fluid Tests

Factors Associated with False-Positive Results from Fingerstick OraQuick ADVANCE Rapid HIV 1/2 Antibody Test

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