Evaluation of the Vidas Chlamydia test to detect and verify Chlamydia trachomatis in urogenital specimens.

Abstract

The Vidas Chlamydia test (CHL) is an automated enzyme-linked immunofluorescence assay for the detection of Chlamydia trachomatis. Positive and equivocal results are confirmed with a blocking assay. A mouse monoclonal antibody directed against the chlamydial lipopolysaccharides was used for the test. The CHL assay is widely used in Europe, but U.S. experience with it is limited. Three clinical test sites (The Arlington Hospital, Arlington, Va., Indiana University, Indianapolis, and the University of California, San Francisco) compared CHL with tissue culture (TC) for the identification of chlamydia in urogenital specimens (2,453 females and 850 males). True positives (TP) were defined as either TC positive or TC negative and CHL positive by a positive direct fluorescent-antibody assay or PCR test. Overall prevalence was 5.5% for females, 10.3% for male urethral swabs, and 10.7% for combined male TC urethral swabs and CHL with first catch urine (FCU) specimens. Compared to TP, CHL and TC had sensitivities of 89.6 and 94.1% with female cervical swabs and 90.9 and 86.4% with male urethral swabs, respectively. CHL sensitivity was 81.2 for male FCU specimens and 77.7% for matching male TC swabs. There were relatively few false-positive results, with all specificities being >99.4%. With the blocking assay, Vidas CHL specificity was >99.7%. However, male FCU specimen sensitivity was compromised because 9.2% (7 of 76) of the TP were initially positive but were not confirmed. An improvement in the Vidas blocking assay is needed before we can recommend its use with male urine. Alternatively, one could argue that the specificity of the test is so high that a confirmatory assay is not needed. For male and female swabs, the Vidas CHL assay has a performance that is similar to that of TC.