Field evaluation of capillary blood and oral-fluid HIV self-tests in the Democratic Republic of the Congo

Abstract

Background HIV self-testing (HIVST) is an additional approach to increasing uptake of HIV testing services. The practicability and accuracy of and the preference for the capillary blood self-test (Exacto Test HIV) versus the oral fluid self-test (OraQuick HIV self-test) were compared among untrained individuals in the Democratic Republic of the Congo (DRC). Methods This multicenter cross-sectional study (2019) used face-to-face, tablet-based, structured questionnaires in a facility-based HIVST approach. Volunteers from the general public who were at high risk of HIV infection, who were between 18 and 49 years of age, and who had signed an informed consent form were eligible for the study. The successful performance and correct interpretation of the self-test results were the main outcomes of the practicability evaluation. The successful performance of the HIV self-test was conditioned by the presence of the control band. The sensitivity and specificity of the participant-interpreted results compared to the laboratory results were estimated for accuracy. Preference for either type of self-test was assessed. Logistic regression models were used to examine factors associated with participants' preference. Results A total of 528 participants were included in this survey. The rate of successful performance of the HIV self-tests was high, with the blood test (99.6%) and the oral-fluid test (99.4%) yielding an absolute difference of 0.2%

Analytical Performance of the Exacto Test HIV Self-Test: A Cross-Sectional Field Study in the Democratic Republic of the Congo

“…Taken together, the excellent performance and usability characteristics of Exacto Test HIV (Biosynex) self-test make the kit a viable option for HIV self-testing in the DRC. The accuracy of the Exacto Test HIV can be compromised by misinterpreted results, regardless of the quality of the test itself [ 11 , 13 ]. This is likely due to visual disturbances, especially for positive results with a low-intensity test band or practical difficulties incorrectly reading self-test results among some individuals, such as those with little education or visual impairments [ 9 , 11 , 14 ].…”

“…The accuracy of the Exacto Test HIV can be compromised by misinterpreted results, regardless of the quality of the test itself [ 11 , 13 ]. This is likely due to visual disturbances, especially for positive results with a low-intensity test band or practical difficulties incorrectly reading self-test results among some individuals, such as those with little education or visual impairments [ 9 , 11 , 14 ]. However, the use of video instruction using local languages will be needed to improve the usability of the self-test and the interpretation of self-test results.…”

“…The test requires a volume of 2.5 μL of capillary blood with 2 drops of buffer or 5 μL of plasma or serum without buffer. The Exacto Test HIV (Biosynex) self-test kits consisted of a test cassette, diluent vial, pipette, alcohol wipe, compress, lancet, dressing, and A3 printed instruction for use with explanatory pictures in French, Lingala, and Swahili languages, as previously described [ 9 , 11 ].…”

“…In brief, untrained participants were asked to conduct the HIV self-test by themselves and to interpret their self-test result in a private setting supervised by an observer (physician or nurse), using instructions for use in their preferred language. The observer was responsible for recording observations concerning the performance of the test, the interpretation of results, and the participants’ impressions, as previously reported [ 11 ]. For method comparison in the field, serological HIV testing was carried out according to the parallel national algorithm of the DRC using Alere Determine HIV-1/2 (Alere Medical Co. Ltd.) and Uni-Gold HIV (Trinity Biotech Manufacturing Ltd.; PNLS 2016).…”

Self-testing for HIV, HBV, and HCV using finger-stick whole-blood multiplex immunochromatographic rapid test: A pilot feasibility study in sub-Saharan Africa

“…HIV self-testing is an innovative strategy to make testing more accessible, confidential, and available at non-traditional venues, such as pharmacies and community venues, as well as in homes, as it offers a discreet, convenient, and empowering way to test [12][13][14]. HIV self-testing has demonstrated high acceptability, feasibility, and accuracy in various untrained populations in sub-Saharan Africa [15][16][17][18][19][20]. The WHO currently considers HIV self-testing to be a strategy that could revolutionize HIV testing to control HIV/AIDS by 2030 [14].…”