Mpox (Monkeypox) diagnostic kits - September 2024

To better describe the current diagnostic alternatives for diagnosing mpox, a search was conducted on the FIND initiative website, the global alliance for diagnostics. As of September 1, 2024, the FIND website lists 131 mpox diagnostic tests. The majority of 98 (74.8%) tests are based on DNA detection using NAATs, while 18 (13.7%) tests detect mpox antigens, 13 (9.9%) tests detect anti-mpox antibodies, 1 (0.8%) test detects both mpox antigens and anti-mpox antibodies and 1 (0.8%) test detects both mpox DNA and RNA. The kits for detecting mpox antigens or anti-mpox antibodies are predominantly RDT (29/31; 93.5%), with the remainder laboratory-based immunoassays (2/31; 6.5%). Importantly, most of these kits, whether NAATs or immunoassays, do not differentiate between Clades I and II, with only two tests capable of specifically detecting DNA of the more aggressive Clade Ib. Overall, 93 (71.0%) of the mpox tests were classified as "regulatory achieved" and 28 (21.4%) tests as "research use only" (RUO), and only five (3.8%) tests - all NAATs - have reached the validation stage.