Assessment of an enzyme immunoassay for diagnosing gonorrhea

Gonozyme, a nonculture enzyme immunoassay for the detection of Neisseria gonorrhoeae antigens from urogenital swab specimens, was approved by the FDA and introduced in the United States in 1982. This assay was compared to standard culture for N. gonorrhoeae in a number of independent studies. In 1983 a modification of the original Gonozyme was developed to improve the specificity of the assay. This modification, which has now replaced the original Gonozyme, was evaluated in clinical studies at eight sites in the U.S.