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Background: While the Roche Cobas CT/NG v2.0 Test is approved for testing from urine, vaginal swabs, endocervical swabs, and cervical Pap specimens, performance of rectal and oropharyngeal samples has not been reported. We conducted an evaluation of this test using extra-genital specimens and measured the impact to patient care when testing extra-genital sites in accordance with prior sexual history.
Methods: Rectal and oropharyngeal swab specimens were dual-collected from each patient and placed into either APTIMA transport media, and tested by APTIMA COMBO 2® Assay (Hologic, San Diego, CA), or Cobas PCR media (Cobas), and tested 3 times by the Cobas CT/NG v2.0 Test (Roche Diagnostics, Indianapolis, IN). In a separate clinical assessment, patients were interviewed about their sexual practices prior to collection of extra-genital specimen(s) and urine. All urine, oropharyngeal and rectal specimens in this analysis were collected in Cobas PCR media and run with the Cobas CT/NG v2.0 Test.
Results: Method correlation of 76 paired rectal swabs showed an overall percent agreement of 93% for CT and 99% for NG. Method correlation of 132 paired oropharyngeal swabs showed an overall percent agreement of 98% for CT and 98% for NG. Rectal and oropharyngeal cobas swabs were highly reproducible for CT and NG (98-99% accuracy). For the clinical assessment, 170 patients were positive for CT/NG by either rectal or oropharyngeal swab. Of these, 96 co-collected urine specimens were negative for CT/NG, suggesting that 56% of patients would have been missed for CT/NG infection if FDA-approved urine collection had been tested alone.
Conclusions:
This study has called attention the differences in sexual practices and the need to test according to those practices. We have found that testing for CT/NG from extra-genital sites have been beneficial in diagnosing infections that would have been ordinarily missed by the traditional FDA-approved urine collected specimens.