Background and objectives: The Digene Hybrid Capture II (HC II) CT/GC Test (Digene Corp., Beltsville, MD) is a new nucleic acid signal amplification-based test for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in specimens from the genital tract. For optimal results, the HC II CT/GC Test employs a special conical shaped brush for cervical specimen collection from nonpregnant women and swabs from pregnant women.
Goals: To validate a protocol for HC II C. trachomatis and N. gonorrhoeae testing of specimens collected for the GenProbe PACE 2 System.
Study design: Specimens were collected from 1,746 patients with a swab and placed in GenProbe transport media according to the manufacturer's recommended procedure. The specimens were first tested at two clinical laboratories by the PACE 2 system, and then blindly tested by HC II CT/GC using an adjusted cutoff value. Discrepant specimens were adjudicated by polymerase chain reaction (PCR), and the result common to two of the three testing methods (HC II, PACE 2, and PCR) was defined as the consensus result.
Results: Combining the data from both sites, the relative sensitivity of the HC II Test compared with the consensus result for the detection of 1,761 specimens for C. trachomatis and 1,750 specimens for N. gonorrhoeae was 100% for both organisms. The relative specificities for C. trachomatis and N. gonorrhoeae detection were 99.8% and 99.7%, respectively. The relative sensitivities of the PACE 2 CT and GC Systems were 86.5% and 87.1%, respectively, with relative specificities of 99.9% and 100%. The difference in sensitivity between HC II and PACE 2 for C. trachomatis detection was significant (P < 0.016).
Conclusion: The HC II CT/GC Test can be performed using specimens collected in GenProbe transport media and has a significantly greater sensitivity for C. trachomatis detection than the PACE 2 System.