Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests

Several countries have recently recommended the expansion of anti-human immunodeficiency virus (HIV) antibody testing, including self-testing with rapid tests using oral fluid (OF). Several tests have been proposed for at-home use, but their diagnostic accuracy has not been fully evaluated. To evalu...

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Bibliographic Details
Published in:	PloS one Vol. 9; no. 6; p. e101148
Main Authors:	Jaspard, Marie, Le Moal, Gwenaël, Saberan-Roncato, Mariam, Plainchamp, David, Langlois, Aurélie, Camps, Pascale, Guigon, Aurélie, Hocqueloux, Laurent, Prazuck, Thierry
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 27-06-2014 Public Library of Science (PLoS)
Subjects:	Accuracy Acquired immune deficiency syndrome Adult Adults AIDS AIDS Serodiagnosis - methods Analysis Antibodies Antiretroviral agents Antiretroviral drugs Antiretroviral therapy Antiviral agents Biology and Life Sciences Blood Case-Control Studies Diagnostic systems Drug therapy Emergency medical care Female Fingers - blood supply Health surveillance HIV HIV Antibodies - blood HIV Infections - diagnosis HIV tests HIV-1 - immunology HIV-2 - immunology Human immunodeficiency virus Humans Immunoglobulins Infections Infectious diseases Laboratory tests Male Marketing Medical diagnosis Medical personnel Medical tests Medicine and health sciences Mens health Patients Public health Reagent Kits, Diagnostic Saliva - virology Savings banks Self Administration Sensitivity and Specificity Sex ratio Sexually transmitted diseases STD Tropical diseases Viruses Workers
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Summary:	Several countries have recently recommended the expansion of anti-human immunodeficiency virus (HIV) antibody testing, including self-testing with rapid tests using oral fluid (OF). Several tests have been proposed for at-home use, but their diagnostic accuracy has not been fully evaluated. To evaluate the performance of 5 rapid diagnostic tests for the detection of anti-HIV-1/2 antibodies, with 4 testing OF and 1 testing whole blood. Prospective multi-center study in France. HIV-infected adults and HIV-uninfected controls were systematically screened with 5 at-home HIV tests using either OF or finger-stick blood (FSB) specimens. Four OF tests (OraQuick Advance Rapid HIV-1/2, Chembio DPP HIV 1/2 Assay, test A, and test B) and one FSB test (Chembio Sure Check HIV1/2 Assay) were performed by trained health workers and compared with laboratory tests. In total, 179 HIV-infected patients (M/F sex ratio: 1.3) and 60 controls were included. Among the HIV-infected patients, 67.6% had an undetectable HIV viral load in their plasma due to antiretroviral therapy. Overall, the sensitivities of the OF tests were 87.2%, 88.3%, 58.9%, and 28% (for OraQuick, DPP, test A, and test B, respectively) compared with 100% for the FSB test Sure Check (p<0.0001 for all comparisons). The OraQuick and DPP OF tests' sensitivities were significantly lower than that of the FSB-based Sure Check (p<0.05). The sensitivities of the OF tests increased among the patients with a detectable HIV viral load (>50 copies/mL), reaching 94.8%, 96.5%, 90%, and 53.1% (for OraQuick, DPP, test A, and test B, respectively). The specificities of the four OF tests were 98.3%, 100%, 100%, and 87.5%, respectively, compared with 100% for the FSB test. An evaluation of candidates for HIV self-testing revealed unexpected differences in performance of the rapid tests: the FSB test showed a far greater reliability than OF tests.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 Competing Interests: The authors declare that no competing interests exist with any firm and there is no conflict of interest. Conceived and designed the experiments: TP GL LH. Performed the experiments: MJ TP AL AG DP MR PC. Analyzed the data: MJ TP LH. Wrote the paper: TP MJ LH.
ISSN:	1932-6203 1932-6203
DOI:	10.1371/journal.pone.0101148