Assessment of enzyme immunoassay and immunofluorescence tests for detection of Chlamydia trachomatis.

Two rapid diagnostic tests for Chlamydia trachomatis (Microtrak, Syva Co., Palo Alto, Calif.; and Chlamydiazyme, Abbott Laboratories, North Chicago, Ill.) were evaluated in comparison with growth of the organism in tissue culture for 2,030 urogenital specimens from men and women. Neither test performed as well as culture, which detected 296 of 310 positive specimens. The overall sensitivity and specificity for Microtrak were 73 and 99%; corresponding values for Chlamydiazyme were 83 and 98%. The majority of false-negative results with both rapid tests occurred when cultures contained less than 10 inclusions per cover slip. There were also areas of unconfirmed reactivity for both tests that led us to suggest that a reporting category of "suspicious" be developed for certain test results. For Microtrak, the suspicious result is a slide containing fewer than 10 elementary bodies; for Chlamydiazyme, it is any absorbance reading less than 0.4. Creation of a "suspicious" category would lower the sensitivity for Chlamydiazyme considerably, to 64%, and increase the positive predictive value for females to 95%. Although this may result in the underreading of some specimens from males, the tests could then be used with greater confidence in females for whom testing is essential for appropriate treatment.