Journal Article

A prospective multi-site study to evaluate the performance and usability of an oral fluid-based HIV self-test in Canada

Nkala, Nontobeko P., Jeyarajah, Nirubini, McBain, Kristin, Vassal, Anne-Fanny, Chan, Arlene, Tharao, Wangari, Ireland, Laurie, Lo Hog Tian, Jason M., McFarland, Abbey, Selfridge, Marion, Thomas, Rejean, Fraser, Chris, Tran, Vanessa, Rourke, Sean B., Lepage, Martin, Halpenny, Roberta, Galli, Richard A., Maraj, Darshanand, da Silva, Mark, Starr, Jared, Payne, Mike, Loutfy, Mona, Mazzulli, Tony

2025

Overview

Background Blood and oral fluid-based HIV self-tests are important for reaching the undiagnosed living with HIV. The study objectives were to evaluate the oral fluid-based OraQuick® HIV Self-Test (HIV-ST) performance in comparison to laboratory reference testing; determine if laypersons can correctly perform the HIV-ST; document if intended users can successfully interpret pre-made contrived positive, negative, and invalid results; and document if intended users can understand the key messages in the product labeling. Methods This prospective study enrolled consenting adult intended users of HIV self-testing from six community health centres in four Canadian provinces between June 2022 and January 2024. Positive and negative agreement was determined by comparing the results of the HIV self-tests with the results of the laboratory-based “gold standard” Abbott Alinity HIV Antigen/Antibody Combo test. Descriptive statistics were used to summarize usability self-test procedure steps. Results Overall, 951 participants were recruited and consented with 911 available for all analyses. With respect to sociodemographics: 84% of participants were between 18–45 years of age, 73% had at least a college education, 48% were Cis-male, 45% were employed; and 26% identified as White, 23% as African, Caribbean or Black, 5% as Indigenous [First Nations, Métis or Inuit], 33% as Asian, and 6% as LatinX. Primary efficacy analysis on the 911 who completed HIV-ST revealed a single confirmed positive participant and a negative percent agreement of 100% (880/880, 95% CI: 99.9–100%) with the comparator method. For usability determination, the average success rate for “critical” steps for completing the test was 94.1%. Approximately 97% of participants found the instructions easy to follow and 98% of participants reported they would use the test again. Of the 465 participants who interpreted the strong positive, weak positive, negative, and invalid pre-made contrived results, the average of correct interpretations ranged from 59–97% Conclusions A licensed oral fluid-based HIV self-test in Canada can present an accurate, easy-to-use, and less invasive alternative to blood-based HIV testing. The addition of an oral-fluid self-test along with the current licensed blood-based HIV self-test could help reach the undiagnosed with HIV in Canada and positively impact HIV testing rates overall by offering individuals a choice of self-testing devices.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acceptance / Accuracy / Adolescent / Adult / Antibodies / Antigens / Autoantigens / Biostatistics / Blood / Canada / Colleges & universities / Diagnosis / Documents / Environmental Health / Epidemiology / Female / HIV / HIV infection / HIV Infections - diagnosis / HIV testing / HIV Testing - methods / Home medical tests / Human immunodeficiency virus / Humans / Laboratories / Male / Medicine / Medicine & Public Health / Middle Aged / Oral fluid-based HIV self-test / OraQuick / Performance evaluation / Prospective Studies / Public Health / Regulatory approval / Saliva - virology / Salivary diagnostics / Self Care - methods / Self testing / Statistical analysis / Statistical tests / Test procedures / Testing / Usability / Vaccine / Young Adult