Impact of reference standard sensitivity on accuracy of rapid antigen detection assays and a leukocyte esterase dipstick for diagnosis of Chlamydia trachomatis infection in first-void urine specimens from men.

A total of 128 previously frozen first-void urine (FVU) specimens from selected asymptomatic men were centrifuged and tested by three Chlamydia trachomatis rapid antigen detection tests and with a leukocyte esterase (LE) dipstick. When the results were compared to those of a reference standard of positivity determined by the Chlamydiazyme enzyme immunoassay as confirmed by a blocking assay, the sensitivities of the Testpack Chlamydia (Abbott), Clearview Chlamydia (Unipath), and Surecell Chlamydia (Kodak) tests and the LE dipstick test were 76.4, 76.4, 67.3, and 88.6%, respectively. Use of the ligase chain reaction (LCR), whose results were confirmed by direct fluorescent-antibody staining of elementary bodies, as the reference standard reduced the sensitivities to 70.9, 67.7, 62.9, and 87.5%, respectively. The specificities by use of LCR as the reference standard were 95.5, 95.5, 100, and 92.4%, respectively. These rapid chlamydial antigen tests performed reasonably well with FVU specimens, but the simple LE dipstick test, which had the highest sensitivity, would have enabled treatment of the greatest number of infected male patients.