BACKGROUND AND OBJECTIVES: The nonisotopic DNA probe assay (PACE 2) was evaluated for the detection of Neisseria gonorrhoeae in urethral and endocervical specimens and compared quantitatively and qualitatively using recommended culture methods. GOAL OF THIS STUDY: To evaluate whether culture methods could be replaced by the DNA probe assay for the diagnosis of N. gonorrhoeae. STUDY DESIGN: A total of 502 men and women were studied, including 42 non-registered and 132 legally registered prostitutes and 115 male and 213 female STD patients. RESULTS: The overall concordance of culture and the PACE 2 assay was 98.4%. Of the tested persons, 9.6% were positive for N. gonorrhoeae by culture technique compared with 11.2% using the DNA probe assay. All samples that were positive in culture were positive in the Gen-Probe test. Of samples positive in Gen-Probe, 14.3% (8/56) were negative in culture. Three of these results were determined false-positives and five were true positives when evaluated by further analysis. The sensitivity and specificity were 90.6% and 100%, for the culture technique, and 100% and 99.3% for the DNA probe assay, respectively, when compared with true positive and negative results. CONCLUSION: The data indicate that the DNA probe assay serves as a suitable screening and diagnostic test for the diagnosis of N. gonorrhoeae in symptomatic and in asymptomatic men and women. When the performance of culture technique is not possible or unreliable, the DNA probe assay can be used for testing those at high risk for gonorrhea. In borderline cases with a low value of RLU, the DNA test should be confirmed to avoid false positive results, especially in women.
BACKGROUND AND OBJECTIVES: The nonisotopic DNA probe assay (PACE 2) was evaluated for the detection of Neisseria gonorrhoeae in urethral and endocervical specimens and compared quantitatively and qualitatively using recommended culture methods. GOAL OF THIS STUDY: To evaluate whether culture methods could be replaced by the DNA probe assay for the diagnosis of N. gonorrhoeae. STUDY DESIGN: A total of 502 men and women were studied, including 42 non-registered and 132 legally registered prostitutes and 115 male and 213 female STD patients. RESULTS: The overall concordance of culture and the PACE 2 assay was 98.4%. Of the tested persons, 9.6% were positive for N. gonorrhoeae by culture technique compared with 11.2% using the DNA probe assay. All samples that were positive in culture were positive in the Gen-Probe test. Of samples positive in Gen-Probe, 14.3% (8/56) were negative in culture. Three of these results were determined false-positives and five were true positives when evaluated by further analysis. The sensitivity and specificity were 90.6% and 100%, for the culture technique, and 100% and 99.3% for the DNA probe assay, respectively, when compared with true positive and negative results. CONCLUSION: The data indicate that the DNA probe assay serves as a suitable screening and diagnostic test for the diagnosis of N. gonorrhoeae in symptomatic and in asymptomatic men and women. When the performance of culture technique is not possible or unreliable, the DNA probe assay can be used for testing those at high risk for gonorrhea. In borderline cases with a low value of RLU, the DNA test should be confirmed to avoid false positive results, especially in women.