Products
3 - BD ProbeTec™ ET Reagents »
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CT/GC Assays
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| » Clinical performance of the BD ProbeTec™ ET CT/GC Assays The BD ProbeTec™ ET amplified DNA assays allow direct, qualitative detection of CT and GC DNA in endocervical swabs, male urethral swabs, and male and female urine specimens (with and without preservative) that are collected from either symptomatic or asymptomatic patients. Prior to product launch, extensive clinical studies were performed to validate performance. The original clinical trial data are published in our package insert, which can be found on-line at www.bd.com/ds/technicalCenter/inserts/pkgInserts.asp and these data show that for endocervical and urethral swabs, the sensitivity and specificity for CT were 93.7 and 97%, respectively, while for GC they were 97.7 and 98.8%. Similarly, urine specimen performance using the Urine Preservative Transport (UPT) tube was tested in a prospective clinical agreement study at four clinical sites, and overall percent agreement with the reference method for CT and GC was 98% for both male and female specimens. This data was used for the FDA and CE clearance of the assay that became available as of 1999. Since product launch, numerous independent studies on the BD ProbeTec™ ET System have been published substantiating the package insert data. The results of several of these studies are summarized in the following table:
Author CT Sensitivity CT Specificity GC Sensitivity GC Specificity Van Dyck et al., * 94% / 100% 100% / 100% 88.9% / 94.5% 100% / 100% Fuller et al. 98% 100% 99% 100% Gaydos et al. 96% 100% - - Chan et al. 95.3% 99.3% 100% 99.7% Levett et al. 97.95% 99.50% 95.8% 100% Laura Dean et al. 95.81% 99.81% - - Kudesia et al. - - 98.1% 100% * Two datasets.
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