HIVST PRODUCTS. As of December 2020, there are four WHO prequalified (PQ) HIVST products: the INSTI HIV Self-Test (Bioanalytical, Canada); the Mylan HIV Self-Test (Mylan, Atomo Diagnostics, Australia); and the OraQuick HIV Self-Test (OraSure Technologies, USA) and the SURE CHECK HIV 1/2 Assay (Chembio, USA), and several others may be expected to come to market.19 An additional six HIV self-tests have been approved by a stringent regulatory authority in one of the founding member countries of the International Medical Device Regulators Forum (IMDRF) or recommended for procurement by the Unitaid/GF EPRD.20 Additional locally manufactured HIVST kits with national-level approval have emerged in some countries (six products identified), including Belarus, Brazil and Nigeria. The quality and performance of these products are largely unknown. There are other HIV self-tests under development, using either whole blood specimens, oral fluid specimens or urine specimens. Despite this encouraging progress toward international approvals, manufacturers remain concerned that in some countries the regulatory process remains opaque, with a lack of clarity about which authorities are responsible for the registration of HIVST products and lengthy in-country validation and registration processes for products even after they have achieved WHO PQ status. Table 1 lists those that have either been prequalified by WHO, approved by a regulatory authority in one of founding-member countries of the International Medical Device Regulators Forum or eligible for procurement on recommendation of the Unitaid/Global Fund EPRD.
HIVST PRODUCTS. Selection of which HIVST products to use must first take account of the regulatory situation in the country, whether there are already regulations governing the use of medical devices or, if not, which substitute regulatory body’s decisions will be used instead. Your situational analysis and additional operational research should also have generated data on the preferences of your target populations for various different types of test kits and culture-specific issues, which will influence product choices. Regardless of the final decision, all HIVST products should have been assessed and approved by a recognized national authority and/or an international body such as WHO, or a founding member of the Global Harmonization Task Force on Medical Devices. This will ensure the procurement of quality HIVST products without expensive and lengthy in- country validation studies. Choose products with acceptable specifications, including adequate sensitivity (proportion of people with the disease correctly identified as reactive by the test) and specificity (proportion of people without the disease correctly identified as non- reactive) of above 95%. HIVST products should be highly sensitive and specific, so that the results are accurate, be simple to use; include all necessary consumables; provide results that are easy to read/interpret within a short period of time and contain clear pictorial instructions and support tools (including information on what to do and where to go after self-testing. HIVST kits should be easy to use. Sample preparation should be simple and only a small number of operator steps, especially timed steps, should be required to perform the test. Each step for HIV testing, from the specimen collection to interpreting the final result, is critical for ensuring a correct result. The more steps, the greater the risk is for user error, which may in turn increase the risk of an incorrect test result. Collecting and transferring specimen has been shown to be particularly prone to error for self-testers, resulting in test system failures, invalid results and suboptimal performance. Thus, an HIV RDT for self-testing with few steps, or ideally one single step, could substantially reduce the risk of a number of user errors. An ideal RDT for self-testing should provide a result in one to twenty minutes and have a read-window where results are stable for more than 60 minutes, after which they give an invalid result. Result windows should be clear and easy t...
