Evaluation of the Hybrid Capture 2 CT/GC DNA tests and the GenProbe PACE 2 tests from the same male urethral swab specimens.

BACKGROUND: A previous study demonstrated that Digene's Hybrid Capture 2 (HC2) DNA tests for detection of and (CT/GC) could be performed using cervical swab specimens collected in GenProbe transport media with significantly greater sensitivity for the detection of than with the GenProbe PACE 2 system. GOAL: The goal was to assess the performance of HC2 tests in comparison with GenProbe PACE 2 tests for the detection of CT/GC in male urethral swab specimens. STUDY DESIGN: A total of 1,202 male urethral swab specimens were collected in GenProbe PACE transport medium. All specimens were first tested with the PACE 2 system, followed by masked HC2 CT/GC testing. The GenProbe AMPLIFIED CT Assay (AMP CT) and PCR/SHARP Signal System (SHARP) were used for adjudication of discrepant results. RESULTS: The prevalence rates for this population were 8.4% for and 14.6% for, based on the adjudicated results. The relative sensitivity and specificity for the detection of were 97.0% and 99.8% for HC2 and 69.3% and 98.3% for PACE 2, respectively. The relative sensitivities for the detection of were 98.9% for HC2 and 99.4% for PACE 2, with the same specificity of 99.9% for both tests. Agreement between the two testing methods was 95.4% for and 99.6% for. CONCLUSION: The HC2 test is compatible with the GenProbe collection medium, with significantly greater sensitivity than the GenProbe PACE 2 test for detecting and similar sensitivities for detecting.

Comparison of Digene hybrid capture 2 and conventional culture for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in cervical specimens.

Digene's Hybrid Capture 2 (HC2) CT/GC, CT-ID, and GC-ID DNA tests were evaluated by comparison to traditional culture methods for detecting Chlamydia trachomatis and Neisseria gonorrhoeae infections in 669 cervical specimens from high-risk female populations attending two sexually transmitted disease clinics. For detection of either or both infections, the HC2 CT/GC test algorithm had 93.8% sensitivity and 95.9% specificity compared to those of culture. After resolution of discrepant results by direct fluorescent-antibody (DFA) staining or PCR assay, the relative sensitivity and specificity of the HC2 CT/GC test algorithm increased to 94.8 and 99.8%, while the values for culture were 83.6% (McNemar's P value, 0.0062) and 100%, respectively. For detection of the individual pathogens, the relative sensitivities for the HC2 CT-ID and GC-ID tests were 97.2 and 92.2% and the specificities were greater than 99% compared to culture adjucated by DFA staining and PCR. Test performance varied at the two clinics: the HC2 CT/GC algorithm, CT-ID, and GC-ID tests had significantly higher sensitivities (McNemar's P value, <0.05) than that of culture for the population at one clinic as well as for the combined populations. At the other clinic, the HC2 tests performed as well as culture.