Evaluation of nucleic acid-based test (PACE 2C) for simultaneous detection of Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical specimens

Abstract

A nucleic acid-based test (Gen-Probe PACE 2C System) was evaluated for the ability to detect Chlamydia trachomatis and Neisseria gonorrhoeae from endocervical specimens in a single assay. Three swab samples, randomized for collection order, were obtained from each patient and tested by N. gonorrhoeae and C. trachomatis culture and by the PACE 2C probe assay. Fifty of 395 specimens were culture positive for N. gonorrhoeae (17 specimens), C. trachomatis (26 specimens), or both (7 specimens), of which PACE 2C testing detected 48 specimens. The PACE 2C assay was positive for 56 specimens, including 8 specimens not positive by culture. Of the total of 10 discrepancies between culture and PACE 2C results, resolution testing yielded four false-negative culture, four false-positive PACE 2C, and two false-negative PACE 2C results. The sensitivity, specificity, and positive and negative predictive values for PACE 2C after reevaluation were 96.3, 98.8, 92.9, and 99.4%, respectively. The overall sensitivities for C. trachomatis and N. gonorrhoeae culture were 89.2 and 88.9%, respectively. The prevalence rate for C. trachomatis was 9.4%, and that for N. gonorrhoeae was 6.8%. The Gen-Probe PACE 2C System is a reliable alternative for screening endocervical specimens for both C. trachomatis and N. gonorrhoeae in a single assay.

Comparison of ligase chain reaction and culture for detection of Neisseria gonorrhoeae in genital and extragenital specimens

“…Our data confirm previous results suggesting that nucleic acid amplification-based assays for N. gonorrhoeae show a specificity equivalent to that of culture, but a sensitivity only slightly higher than that of culture for the diagnosis of infection with this organism in men (2,5,10). The sensitivity of LCR applied to FVU from men was only slightly less than that of the same assay applied to urethral swabs, suggesting that gonococcal infection can reliably be detected by LCR assay of this specimen that is obtained by noninvasive means.…”

Multiplex PCR for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Genitourinary specimens

“…Nucleic acid amplification tests have generally been more sensitive than traditional tests for the detection of C. trachomatis (7,10,14,16,19,20,22,23), but they have not been extensively evaluated for N. gonorrhoeae. Although multiplex PCR (M-PCR) has been applied to the detection of multiple viruses in clinical specimens (1,21,27,29), this approach to diagnosis has only recently been applied for the detection of bacterial STDs (13,24). We report here the development of an M-PCR for the simultaneous detection of C. trachomatis and N. gonorrhoeae in genitourinary specimens and show that M-PCR is more sensitive than traditional tests for these STDs.…”

Evaluation of the Abbott LCx Assay for Detection of Neisseria gonorrhoeae in Endocervical Swab Specimens from Females

“…The enzyme immunoassay methods have reported sensitivities ranging from 60.8% (12) to 92.4% (5) when tested on female endocervical specimens and 62.5% (11) when tested on female urine specimens. The DNA probe assay has a reported sensitivity ranging from 96.3% (7) to 100% (10) and a specificity of greater than 99% (6,7,10,13). In several studies comparing culture to DNA probe assays, reported culture sensitivities have ranged from 88.9% (7) to 90.6% (10).…”

“…The DNA probe assay has a reported sensitivity ranging from 96.3% (7) to 100% (10) and a specificity of greater than 99% (6,7,10,13). In several studies comparing culture to DNA probe assays, reported culture sensitivities have ranged from 88.9% (7) to 90.6% (10). This suggests that molecular methods may be an improvement over traditional culture.…”