In order to demonstrate the reliability of UriSwab, a trial was conducted using urine samples that had previously returned a detected result for Chlamydia trachomatis and/or Neisseria gonorrhoeae. Urine specimens (115 samples) were received from sexual health clinics and tested using the Roche Cobas 4800 CT/NG method. Concurrently, the urine samples were pipetted directly on to the sponge applicator of the UriSwab, simulating micturition, and the urine harvested from the UriSwab was tested using the Roche Cobas 4800 method. Of the 87 standard urine specimens that were C. trachomatis detected, 85 (98%) were also detected in the corresponding UriSwab specimen (sensitivity 97.7%, specificity 95.7%). Of the 34 standard specimens that were N. gonorrhoeae detected, 33 (97%) were also detected in the corresponding UriSwab specimen (sensitivity 97.1%, specificity 100%). The performance of the UriSwab in this trial was comparable with the testing of neat first-catch urine specimens for both C. trachomatis and N. gonorrhoeae.
Keywords: Chlamydia trachomatis; Neisseria gonorrhoeae; UriSwab; diagnosis, urine; nucleic acid amplification test; sexually transmitted infections; specimen collection.