A Preliminary Evaluation of the Gonozyme® Test

Abstract

Gonozyme® is a solid-phase enzyme immunoassay that detects antigens of Neisseria gonorrhoeae in clinical specimens. The test was 100% sensitive and 96.8% specific when applied to 71 urethral specimens from men with symptomatic urethritis, and 89.5% specific for 19 urethral specimens from men examined after eradication of gonorrhea by antibiotics. For cervical specimens obtained before therapy from 368 women with gonorrhea, the Gonozyme® test had a sensitivity of 88.5% and a specificity of 94.3%. The test was 100% specific when used for testing of 37 cervical specimens obtained after therapy of gonorrhea. The predictive values of a positive Gonozyme® test were 90.5% for cervical specimens from women attending sexually transmitted disease clinic and 97% for urethral specimens from men with urethritis. The predictive values of negative Gonozyme® tests in these same circumstances were 100% for urethral specimens and 93.6% for cervical specimens.