Finger-Stick Whole Blood HIV-1/-2 Home-Use Tests Are More Sensitive than Oral Fluid-Based In-Home HIV Tests

被引:31
作者
Jaspard, Marie [1 ]
Le Moal, Gwenael [2 ]
Saberan-Roncato, Mariam [3 ]
Plainchamp, David [2 ]
Langlois, Aurelie [1 ]
Camps, Pascale [3 ]
Guigon, Aurelie [4 ]
Hocqueloux, Laurent [1 ]
Prazuck, Thierry [1 ]
机构
[1] CHR, Source Infect & Trop Dis Dept, Orleans, France
[2] CHU Poitiers, Infect & Trop Dis Dept, Poitiers, France
[3] CH Rochelle, Dept Infect Dis, La Rochelle, France
[4] CHR, Source Lab Microbiol, Orleans, France
关键词
IMMUNODEFICIENCY-VIRUS TYPE-1; ANTIRETROVIRAL THERAPY; ANTIBODY TESTS; INFECTION; DIAGNOSIS; PERFORMANCE;
D O I
10.1371/journal.pone.0101148
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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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