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Performance of a rapid and simple HIV testing algorithm in a multicenter phase III microbicide clinical trial

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dc.contributor.author Crucitti, T.
dc.contributor.author Taylor, D.
dc.contributor.author Beelaert, G.
dc.contributor.author Fransen, K.
dc.contributor.author Van Damme, L.
dc.date.accessioned 2011-10-05T09:46:33Z
dc.date.available 2011-10-05T09:46:33Z
dc.date.issued 2011
dc.identifier.issn 1556-679X
dc.identifier.doi http://dx.doi.org/10.1128/CVI.05069-11
dc.identifier.other ITG-M1A
dc.identifier.other ITG-M3B
dc.identifier.other ITG-M4A
dc.identifier.other MICRO
dc.identifier.other U-ARLAB
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other Abstract
dc.identifier.other UPD38
dc.identifier.uri http://hdl.handle.net/10390/6680
dc.description.abstract A multi-test sequential algorithm based on Rapid/Simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples from patients after their enrollment in the trial. The specimens were tested in a serial procedure using three different rapid tests (Determine HIV-1/2 (Abbott), SD Bioline HIV 1/2 3.0 (Standard Diagnostics), and Uni-Gold HIV (Trinity Biotech)). In the event of discordant results between the Determine HIV 1/2 and SD Bioline HIV 1/2 3.0 tests, a third assay (i.e., Uni-Gold HIV) determined the final outcome. When the final outcome was positive, a second specimen was collected and tested with the same algorithm, only if a positive result was obtained with this sample the participant was informed of her positive serostatus. A total of 5734 post-enrollment specimens obtained from 1398 women were tested. Forty-six women tested positive according to the testing algorithm performed on the first collected specimen. Confirmatory testing results obtained at the ITM confirmed that 42 women were truly infected. Two out of four initial false positives tested negative upon testing of a second blood specimen. The other two tested false positive twice using specimens collected on the same day. A high percentage of specimens reactive with the Determine HIV-1/2 assay only were observed in the study site in Kampala. This result did not appear to be associated with pregnancy or malaria infection. HIV testing algorithms including only R/S assays are suitable for use in clinical trials, provided that adequate quality assurance procedures are in place. en
dc.language English en
dc.subject Viral diseases en
dc.subject HIV en
dc.subject AIDS en
dc.subject Testing en
dc.subject Performance en
dc.subject Rapid diagnostic tests en
dc.subject Assays en
dc.subject Algorithms en
dc.subject Laboratory network en
dc.subject Microbicides en
dc.subject Prevention en
dc.subject Confirmation en
dc.subject False-positive en
dc.subject Clinical trials en
dc.subject Women en
dc.subject Uganda en
dc.subject Africa, East en
dc.title Performance of a rapid and simple HIV testing algorithm in a multicenter phase III microbicide clinical trial en
dc.type Article en
dc.citation.issue 9 en
dc.citation.jtitle Clinical and Vaccine Immunology en
dc.citation.volume 18 en
dc.citation.pages 1480-1485 en
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/21752945
dc.citation.jabbreviation Clin Vaccine Immunol en


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