Evaluation of the rapid CLEARVIEW Chlamydia test for direct detection of chlamydiae from cervical specimens.

The CLEARVIEW Chlamydia test (Unipath, Mountain View, Calif.), a 30-min immunoassay, was compared to a standard tissue culture technique for the direct detection of chlamydiae from 677 cervical specimens obtained from 667 patients. For data analysis, 15 specimens were eliminated because of toxicity in the culture and 14 were eliminated because of failure of the extracted specimen to migrate in the CLEARVIEW test, one of the latter group being culture positive. Of the remaining 648 specimens, 40 were culture positive, of which 38 were detected by the CLEARVIEW test, and 12 specimens were positive only by the CLEARVIEW test. Therefore, the CLEARVIEW in comparison with culture was easier to perform, more rapid, and in this low prevalence (6.2%) population had a 95.0% sensitivity, 98.0% specificity, and 76.0% positive and 99.7% negative predictive values.