The FDA has cleared the Amplicor CT/NG Test for C. trachomatis and N. gonorrhoeae in microwell plate format using PCR technology. The microwell plate test provides greater sensitivity than traditional culture tests, so more positive specimens can be detected. The format is suited for high-throughput reference and public health labs.
The test was cleared with male and female urine claims (female urine testing for chlamydia only), and female endocervical and male urethral swabs. In January, the National Committee on Quality Assurance added chlamydia screening to its HEDIS 2000 to spur to routine screening for these diseases.
Like the automated version of this dual test, the Cobas Amplicor CT/NG test, result integrity is built into the Amplicor CT/NG Test with Amperase (uracil-N-glycosylase, UNG) the contamination control, and the optional Internal Control that ensures there is no inhibition to amplification. Roche Diagnostics
