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Comparative Study
. 2014 Jun 27;9(6):e101148.
doi: 10.1371/journal.pone.0101148. eCollection 2014.

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

Marie Jaspard  1 , Gwenaël Le Moal  2 , Mariam Saberan-Roncato  3 , David Plainchamp  2 , Aurélie Langlois  1 , Pascale Camps  3 , Aurélie Guigon  4 , Laurent Hocqueloux  1 , Thierry Prazuck  1
Affiliations
Comparative Study

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

Marie Jaspard et al. PLoS One. .

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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Conflict of interest statement

Competing Interests: The authors declare that no competing interests exist with any firm and there is no conflict of interest.

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