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. 2007 Jan 31;2(1):e185.
doi: 10.1371/journal.pone.0000185.

Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test

Krishna Jafa  1 , Pragna Patel, Duncan A Mackellar, Patrick S Sullivan, Kevin P Delaney, Tracy L Sides, Alexandra P Newman, Sindy M Paul, Evan M Cadoff, Eugene G Martin, Patrick A Keenan, Bernard M Branson; OraQuick Study Group
Affiliations

Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test

Krishna Jafa et al. PLoS One. .

Abstract

Background: In March 2004, the OraQuick rapid HIV antibody test became the first rapid HIV test approved by the US Food and Drug Administration for use on oral fluid specimens. Test results are available in 20 minutes, and the oral fluid test is non-invasive. From August 2004-June 2005, we investigated a sudden increase in false-positive results occurring in a performance study of OraQuick oral-fluid rapid HIV tests in Minnesota.

Methodology/principal findings: In a field investigation, we reviewed performance study data on oral-fluid and whole-blood OraQuick rapid HIV test device lots and expiration dates and assessed test performance and interpretation with oral-fluid and whole-blood specimens by operators who reported false-positive results. We used multivariate logistic regression to evaluate client demographic and risk characteristics associated with false-positive results. Next, we conducted an incidence study of false-positive OraQuick rapid HIV tests in nine US cities and tested both oral-fluid and finger-stick whole-blood specimens from clients; reactive tests were confirmed with Western blot. Sixteen (4.1%) false-positive oral-fluid results occurred in the performance study from April 15, 2004 through August 31, 2004 with unexpired devices from six test lots among 388 HIV-uninfected clients (specificity, 95.9%; 95% CI: 93.4-97.6). Three test operators who had reported false-positive results performed and interpreted the test according to package-insert instructions. In multivariate analysis, only older age was significantly associated with false-positive results (adjusted odds ratio = 4.5, 95% CI: 1.2-25.7). In the incidence study, all valid oral-fluid and whole-blood results from 2,268 clients were concordant and no false-positive results occurred (100% specificity).

Conclusions/significance: The field investigation did not identify a cause for the increase in false-positive oral-fluid results, and the incidence study detected no false-positive results. The findings suggest this was an isolated cluster; the test's overall performance was as specified by the manufacturer.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1
Epidemic curve of false-positive OraQuick rapid HIV antibody test results, oral fluid, by Month and Lot, University of Minnesota study, July 2002 through August 2004.
See this image and copyright information in PMC

References

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