A laboratory-based evaluation of the BioStar Optical ImmunoAssay point-of-care test for diagnosing Neisseria gonorrhoeae infection

The development of gonococcal point-of-care tests (POCTs) has been challenging due to the relatively monomorphic nature of the Neisseria genus. The BioStar Optical ImmunoAssay (OIA) POCT for diagnosing Neisseria gonorrhoeae infection detects a specific epitope on the L7/L12 ribosomal protein, which reduces cross-reactivity with other neisseriae, and produces a highly specific test. A laboratory-based evaluation of this POCT was performed to determine its analytical sensitivity and specificity. A panel of N. gonorrhoeae (n=158) and non-gonococcal Neisseria (n=62) isolates were examined. The OIA GC POCT positively reacted with 99.4% of N. gonorrhoeae isolates and produced no reaction with 88.7% of non-gonococcal Neisseria isolates. It cross-reacted with six strains of N. meningitidis and one non-speciated Neisseria sp., but failed to produce a positive result with one isolate of N. gonorrhoeae. The OIA GC POCT required a bacterial suspension of similar to 6.4x10(5) c.f.u. N. gonorrhoeae ml(-1) and similar to 6.2x10(6) c.f.u. N. meningitidis ml(-1) to produce a reactive result. The OIA POCT detected the majority of N. gonorrhoeae (99.4%) isolates examined.