Abstract

[TMA] assay, APTIMA Combo 2 [AC2], is available for the detection of CT and GC RNA in clinical specimens and positives can be confirmed in alternate individual TMA tests [ACT and AGC]. We evaluated the utility of performing AC2 testing for GC on specimens submitted for GC culture or CT TMA. Methods: From March to August 2008, a total of 81,405 samples from men and women attending doctors’ offices, in Ontario, were inoculated onto modified Thayer-Martin medium and a second sample collected for TMA was tested for GC RNA by AC2 [Gen-Probe] by direct tube sampling [DTS 1600] or on the TIGRIS instrument [group A]. A second group of swabs [n = 14,667] which had no GC culture ordered but were submitted for CT testing in AC2 were tested for GC RNA [group B]. A proportion of AC2-GC positive samples with sufficient volume [n = 66] were retrieved and retested by AGC [confirmatory testing]. Results: The GC prevalence rate by culture was 0.2% [6.0% men/ 0.09% women]. Ninety-nine percent of the samples were from women. The AC2 test for GC in group A detected all culture positives and 67 additional positives from the culture-negative group, increasing the prevalence rate to 0.25. Seventy-five AC2-GC positives were found in group B. Confirmatory testing of representative samples from Groups A and B with AGC found 97% [64/66] positive. Conclusion: Sixty-seven extra cases of N. gonorrhoeae infections were diagnosed by AC2 testing samples submitted for culture. GC positives were also found in 75 (0.5%) of samples submitted for AC2 CT testing without an order for GC. Ninety-seven percent of samples retested by an AGC test confirmed positive. AC2 testing enabled identification and treatment of 142 cases of gonorrhea which would have been reported negative or would not have been investigated.

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