RE: A must read...3 Aug 2021 05:03
'The use of Affimers as detection molecules also provides additional benefits due to their low production cost and consistent batch uniformity. In our hands, these tests present 100% specificity for CCHFV NP and their LOD is 15 ng of recombinant CCHFV NP/strip. There are no previous studies describing the LOD needed for LFA devices to successfully detect CCHFV NP in acute patient samples, nor reference antigen preparation standards for hemorrhagic fever viral NPs [34]. But different types of point-of-care diagnostic tests have shown the ability to detect hemorrhagic fever viral NPs in virus isolates and patient samples, such is the case for Lassa virus [35], Ebola virus [36] or RVFV [37]. In order to determine if the sensitivity of our current device is sufficient to detect CCHFV NP in real patient samples, it will need to be experimentally tested and optimized using patient samples under high-level biosafety containment. Nonetheless, the results presented in this study serve as proof of concept for the use of Affimers in LFAs and represent the first prototype point-of-care diagnostic test for the detection of recombinant CCHFV NP in sera described to date. These findings represent a possible starting point for the future development of Affimer-based diagnostic assays for the detection of CCHFV NP, contributing to the preparedness for potential future outbreak scenarios.'