TestPack Chlamydia for chlamydial detection in physicians' offices.

Chlamydia trachomatis is widely recognized as the most prevalent sexually transmitted disease. It is often asymptomatic and can lead to serious sequelae, including infertility and ectopic pregnancy. For this reason, testing of patients at risk is a necessary health care measure. This study compared TestPack Chlamydia to Chlamydiazyme for the direct detection of chlamydial antigen in endocervical specimens. One thousand three hundred seventy-six patients seen in 47 private practice offices of obstetrician-gynecologists and family practitioners were screened. TestPack Chlamydia, a 25-minute enzyme immunoassay, had a specificity of 98.6% and sensitivity of 90% when compared with Chlamydiazyme, a four-hour laboratory test. The overall prevalence of chlamydial infection in this population was 3.6%. The prevalence among patients less than or equal to 24 years of age was 7.6% higher among subgroups with symptoms and other identified risk factors. The positive predictive value of TestPack Chlamydia (83.7%) makes it an accurate assay for testing women at risk for chlamydial infections.