Abstract
The Kodak Surecell™ Chlamydia Test Kit is a monoclonal-polyclonal antibody based, membrane antigen binding enzyme immunoassay. The unique test cell (patent issued) is divided into three separate wells, labeled "1-2-3". Each test cell incorporates a separate positive and negative control for each patient sample. Interference from endogenous whole blood, white blood cells, and mucus has been eliminated. The test requires approximately 21 minutes to run 1 to 6 tests. A multi-center evaluation of the test was run to determine clinical performance characteristics relative to standard culture techniques and a direct fluorescent antibody (DFA) test. The detection of antigen and cell culture results were compared for samples taken simultaneously on 496 patients. Compared to culture, the test showed 87.3% sensitivity and 97.5% specificity with a prevalence rate of 27%. In addition, compared to the DFA test, on 234 samples, the sensitivity was 96.3% and the specificity was 97.1% with a prevalence rate of 11.5%.
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