Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies

Abstract

In diverse settings in four studies, the OraQuick test showed high sensitivity and specificity for HIV antibody in whole blood and oral fluid specimens. Slightly more false-positive and false-negative results occurred with oral fluid than with whole blood, but performance with both specimen types was similar to, or better than, that of conventional EIAs.

Oral fluid-based rapid HIV testing: issues, challenges and research directions

“…Although, the majority of these rapid tests utilize whole blood, plasma and finger stick blood specimens, a few tests employ nonconventional specimens, such as saliva, oral mucosal fluid and urine [4,5]. Oral fluid-based rapid tests have potential advantages over blood-based rapid tests because of their convenience, noninvasiveness, ease of specimen collection, cultural acceptance, high accuracy and rapidity [4,[6][7][8].…”

“…These studies have evaluated various outcomes, such as diagnostic accuracy, client preference, acceptability, uptake and cost-and time-effectiveness [13][14][15][16][17]. It is now an established fact that diagnostic accuracy of oral rapid point-of-care tests is high and that their test results are consistent across developed and developing countries [7,13,18]. However, although accuracy is very high, oral fluid test results are considered preliminary.…”

“…For example, in 2005, there were reports of falsepositive results with the oral OraQuick test from selected clinics in New York city and San Francisco in the USA [18]. However, subsequent investigations by the CDC were unable to clarify whether the quality of kits or inadequate quality control was responsible for the false-positive results [7,18]. By contrast, more recently, a study from India showed 100% sensitivity and specificity of the oral fluid-based OraQuick RAPID HIV1/2 test, demonstrating excellent performance of oral fluid testing even in a rural setting in India [13].…”

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

“…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.…”

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.…”