Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeaeinfection in syndromic management settings: a cross-sectional performance evaluation

A rapid and affordable point-of-care test is a priority for Neisseria gonorrhoeaecontrol. WHO and Foundation for Innovative New Diagnostics (FIND) have a target product profile for a non-molecular N gonorrhoeaerapid point-of-care test that requires a clinical sensitivity of greater than 80% and a specificity over 95% to be considered useful in syndromic management; test turnaround time should be 30 min or under, and the test should cost less than US$3. A novel lateral flow assay (LFA) was developed to achieve that profile.