Multicenter Evaluation of AMPLICOR and Automated COBAS AMPLICOR CT/NG Tests for Neisseria gonorrhoeae

摘要: The fully automated COBAS AMPLICOR CT/NG and semiautomated tests were evaluated in a multicenter trial for their ability to detect Neisseria gonorrhoeae infections. Test performance compared that of culturing was 2,192 matched endocervical swab urine specimens obtained from women 1,981 urethral men. Culture-negative, PCR-positive tested positive confirmatory PCR test an alternative target sequence within the N. 16S rRNA gene considered be true positives. overall prevalences gonorrhea 6.6% 20.1% formats yielded concordant results 98.8% exhibited virtually identical sensitivities specificities. follow are format. With infected patient as reference standard, resolved 92.4% 64.8% female specimens. There no significant differences these rates between with without symptoms. Among symptomatic men, 94.1% 98.1% swabs; asymptomatic 42.3 73.1%, respectively. In comparison, 84.8% specimens, 92.7% male only 46.2% When analyzed if single had been performed on specimen type, sensitivity always higher. specificities 99.5% 99.8% 98.9% 99.9% internal control revealed 2.1% inhibitory when initially tested. Nevertheless, valid 99.2% because 60.0% not second aliquot high specificity men thus is well suited diagnosing screening infection.