Validity and cost-effectiveness of the Gonozyme test in the diagnosis of gonorrhea.

Although bacterial culture is considered to provide the most definitive diagnosis of gonorrhea, it has limitations when specimens must be transported long distances. A study was carried out to evaluate the validity and cost-effectiveness of an alternative method of diagnosing gonorrhea, the Gonozyme test, a commercially available enzyme immunoassay. Urogenital specimens from 100 men and 100 women with symptoms suggestive of or a history of exposure to gonorrhea were tested for the presence of Neisseria gonorrhoeae by means of bacterial culture and for gonococcal antigen with the Gonozyme test. The specimens from the men were also examined by means of microscopy of Gram-stained smears. The sensitivity and specificity of the Gonozyme test with reference to culture results were 95.6% and 97.4% respectively in the men and 84.2% and 98.7% in the women. The predictive value of a positive result was 91.6% in the men and 94.1% in the women, and the predictive value of a negative result 98.6% in the men and 96.3% in the women. The cost-effectiveness of the Gonozyme test was higher than that of bacterial culture in this population, which had a high prevalence rate of gonorrhea (23% in the men and 19% in the women). The Gonozyme test would be an adequate alternative to culture for the diagnosis of gonorrhea and contact tracing in areas far from diagnostic laboratories.