Limulus lysate assay in detection of gonorrhea in women from a low-incidence population.

An evaluation of the limulus amebocyte lysate assay for detection of gonococcal endotoxin in cervical secretions was undertaken in 48 women from an ambulatory population with a low incidence of gonococcal infection. When cervical secretions were diluted 1 : 2,000, positive limulus amebocyte lysate assay results were obtained in four women (100%) with culture-proved gonococcal infection, and negative results were obtained in 25 of 44 women (57%) with culture-negative specimens. The limulus amebocyte lysate assay was not sufficiently specific in a low-incidence, largely asymptomatic population to be recommended as a rapid diagnostic procedure (60 minutes) in such a group. Standardization of sampling technique, size, and reagent preparation and elimination of vaginal contamination of cervical secretions may produce a limulus amebocyte lysate test with more consistent performance characteristics in varied populations. Since the predictive value of a test varies with the prevalence of the disease in the populations tested, a test proposed for use in a population with a low likelihood of disease must be tested in such a population.