Laboratory evaluation of the MedMira Multiplo Complete Syphilis (TP/nTP) Antibody Test using paired serum and simulated whole-blood specimens

Syphilis cases have been on the rise in Canada, and rapid point-of-care test (POCT) options may aid in timely diagnosis and treatment, thereby preventing further spread of infection. This study provides a laboratory evaluation of the performance of the MedMira Multiplo Complete Syphilis (TP/nTP) Antibody Test in comparison with the current conventional testing methods. Two operators independently performed testing in a blinded manner using 130 paired serum and simulated blood specimens, with the results compared with the corresponding known conventional syphilis serology test results. Overall, among specimens known to be CMIA-positive and RPR-reactive, with a titre ≥1:8, the sensitivity and specificity of the POCT when tested with sera were 97.5% and 70%, respectively, for operator 1, and 100% and 61.1%, respectively, for operator 2. With simulated blood specimens and the same criteria, the sensitivity and specificity of the POCT were 95.0% and 82.2%, respectively, for operator 1, and 100.0% and 74.4%, respectively, for operator 2. Further evaluation in the field is necessary to determine the performance and acceptability of this device in clinical settings.