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.