title: Finger-stick whole blood HIV-1/-2 home-use tests are more sensitive than oral fluid-based in-home HIV tests.
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.
  
  
  CONCLUSIONS
  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.
authors: CHR d'Orléans - La Source, Infectious and Tropical Diseases Department, Orléans, France.
authors: Marie
authors: M
authors: Jaspard
authors: CHU de Poitiers, Infectious and Tropical Diseases Department, Poitiers, France.
authors: Gwenaël
authors: G
authors: Le Moal
authors: CH de La Rochelle, Infectious Diseases Department, La Rochelle, France.
authors: Mariam
authors: M
authors: Saberan-Roncato
authors: CHU de Poitiers, Infectious and Tropical Diseases Department, Poitiers, France.
authors: David
authors: D
authors: Plainchamp
authors: CHR d'Orléans - La Source, Infectious and Tropical Diseases Department, Orléans, France.
authors: Aurélie
authors: A
authors: Langlois
authors: CH de La Rochelle, Infectious Diseases Department, La Rochelle, France.
authors: Pascale
authors: P
authors: Camps
authors: CHR d'Orléans - La Source, Laboratory of Microbiology, Orléans, France.
authors: Aurélie
authors: A
authors: Guigon
authors: CHR d'Orléans - La Source, Infectious and Tropical Diseases Department, Orléans, France.
authors: Laurent
authors: L
authors: Hocqueloux
authors: CHR d'Orléans - La Source, Infectious and Tropical Diseases Department, Orléans, France.
authors: Thierry
authors: T
authors: Prazuck
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D000328:Adult; D016022:Case-Control Studies; D005260:Female; D005385:Fingers / Q000098:blood supply*; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D008297:Male; D011933:Reagent Kits, Diagnostic; D012463:Saliva / Q000821:virology*; D012646:Self Administration; D012680:Sensitivity and Specificity
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic