Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing

Abstract

The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the manufacturer and evaluate quality assurance procedures.

Rapid Detection of HIV-1 and 2 Antibodies by using Oral Fluid: A Multicentric Pilot Study in India

“…These findings are in accordance with a previous study done in rural population in India, 25 although there were conflicting reports of lower sensitivity and specificity of oral fluid-based tests elsewhere with high incidence of false-positive and false-negative results. 17,18,21,26,27 As depicted in our study, the OraQuick test using oral fluid seemed to be of patient's preference than the blood-based test as it was a painless, simple and noninvasive procedure. This was also the test administrator's preference over the conventional blood-based tests as it was rapid, safe with least occupational exposures, easier sample collection and simple to perform.…”

“…It can also be used for oral fluids and serum. 7,9,[15][16][17][18][19] Oral rapid point of care HIV tests score over blood tests in their quality, rapidity, convenience, ease of sample collection and feasibility 15 . While these aspects were tested elsewhere, there is no known data from the dental set-up in India.…”

Saliva Testing as a Practical Tool for Rapid HIV Screening

“…A number of brief narrative reviews published between 1994-2006 have focused predominantly on the description of oral rapid test technologies, although this early work has not evaluated diagnostic accuracy. Two more recent systematic reviews on diagnostic accuracy have been conducted (Wesolowski, 2006;Pai, 2007). These include a review undertaken by the CDC as part of a post-marketing surveillance of one rapid test (Wesolowski, 2006) and a systematic review focused exclusively on performance of all rapid tests in pregnant women (Pai, 2007).…”

“…Two more recent systematic reviews on diagnostic accuracy have been conducted (Wesolowski, 2006;Pai, 2007). These include a review undertaken by the CDC as part of a post-marketing surveillance of one rapid test (Wesolowski, 2006) and a systematic review focused exclusively on performance of all rapid tests in pregnant women (Pai, 2007). A recent meta-analysis has evaluated OMT, saliva based rapid and point of care tests in at-risk populations worldwide from 1986-2011 (Balram & Pai, 2010).…”

Scope of Rapid HIV Testing in Urban U.S. Hospitals

“…Since November 2007, four have been approved for point-of-care use by trained staff in nonclinical settings under the 1988 Clinical Laboratory Improvement Amendments (CLIA). [6][7][8][9][10][11][12] All reactive rapid test results require confirmatory testing. 13 Rapid HIV testing in hospitals has been shown to be easy to use, to increase rates of results receipt, to be acceptable to patients, and to increase quality of care.…”