Evaluation of the Gen-Probe PACE II assay for the direct detection of Neisseria gonorrhoeae in endocervical specimens.

Evaluation of a non-isotopic DNA-rRNA hybridization assay [Probe Assay-Chemiluminescence Enhanced System (PACE II, Gen-Probe, San Diego, CA)] for the direct detection of Neisseria gonorrhoeae from clinical specimens was compared with culture. Culture and probe tests were performed on 795 endocervical specimens. Results demonstrated that total positives by culture were 18 (2.3% of total); both culture and the DNA-rRNA assay agreed in all cases but four. The PACE II yielded four hybridization-positive results with negative companion cultures. The sensitivity, specificity, and positive and negative predictive values for PACE II were 100%, 99.5%, and 82%, and 100%, respectively. The four discrepant results were resolved using a competitive nucleic acid hybridization assay with recalculated sensitivity, specificity, and positive and negative predictive values of 100, 99.7, and 91.6 and 100%, respectively. Overall, the DNA-rRNA assay offered a number of advantages over culture. The assay was more rapid, able to be performed directly on clinical specimens, and provided superior transport stability.