A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa

Abstract

Only 20% of people with hepatitis C virus (HCV) know their status. In low-income countries diagnosis is under 10%. Self-testing for HCV antibodies (HCVST) could expand the coverage of HCV testing services. Currently, there are no stringent regulatory authority (SRA) approved HCVSTs, therefore lay-user usability of three prototype kits was assessed. This was a cross-sectional observational study conducted with 171 (CareStart n = 60, Bioline n = 52, First Response n = 59) participants. Participants were given one of the three HCVST kits with only instructions for use (IFU) and asked to perform the test in front of a professional trained in rapid diagnostic tests (RDT). Usability indices were calculated based on the correctness of performing each step of the product-specific process followed by contrived results interpretation and a post-test interview. The usability index was 93.9% for CareStart, 90.7% for Bioline and 94.9% for First Response. Most errors were on incorrect handwashing, sample collection and transfer to the test device. An average of 93.1% of contrived results were correctly interpreted, with most errors related to interpreting invalid results. Most participants (n = 167) stated they would visit a clinic after a positive result. With negative results, nearly half (28/60 (46.7%)) stated they should condomize, while just over two-thirds of participants that used Bioline (35/52 (67.3%)) and First Response (38/59 (64.4%)) said they should re-test. Most participants (n = 162) found the devices easy to use. Participants liked that self-testing was fast, private and convenient, however there were some confusion with IFU steps and pictures, finger-pricking with the lancet, collecting blood after the finger-prick, and transferring the sample/buffer. Prototype HCVST kits exhibit high usability and result interpretation by lay-users, and should be considered for SRA approval.

Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study

“…Increasing access to HCV testing among high-risk groups in low-and middle-income countries is essential to achieve WHO viral hepatitis elimination goals by 2030. Recently published reports showed high usability and acceptability of HCV self-testing in the general population in Egypt, South Africa and Rwanda [36,40,41] as well as in high-risk populations in Vietnam [37]. We conducted the first study to assess the usability and acceptability of self-testing for HCV among PWID in Kenya.…”

Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa

“…Both these studies indicate that the idea of performing self-tests for sexually transmitted infections can be attractive to users irrespective of their economic context. Already, evidence suggests that the use of pregnancy self-tests remains consistent [27] and, more recently, hepatitis C virus self-test studies are reporting high usability and performance [28,29]. These examples indicate an increasing acceptance of the use of self-tests for identifying the presence of widespread health conditions.…”

Rapid Diagnostics for Hepatitis B and C Viruses in Low- and Middle-Income Countries

“…Rapid tests that are performed within health facilities staffed by health professionals are POC tests, which permit rapid diagnosis and treatment or entry into care in a single visit (54). Self-testing strategies which remove the requirement to undergo POC testing at a healthcare facility have been assessed in LMIC regions and have shown advantages of ease of use, convenience, and privacy; however, provision of testing instructions, at the point of sale (pharmacy or hospital) is likely required to minimize confusion and ensure the procedure is followed correctly (55,56). The major limitations of most POC tests in LMIC involve procurement, distribution and handling of POC tests, training of personnel, and regulatory protocols which may hinder access in certain LMIC (32).…”