{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T09:57:39Z","timestamp":1773655059428,"version":"3.50.1"},"reference-count":0,"publisher":"Australian Centre for Disease Control","license":[{"start":{"date-parts":[[2003,9,30]],"date-time":"2003-09-30T00:00:00Z","timestamp":1064880000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Commun Dis Intell (2018)"],"abstract":"<jats:p>The Roche Cobas Amplicor\u00ae\u00a0Chlamydia trachomatis\/Neisseria gonorrhoeae\u00a0polymerase chain reaction (PCR) assay can simultaneously detect both\u00a0C. trachomatis\u00a0and\u00a0N. gonorrhoeae,\u00a0and has been cleared by United States Food and Drug Administration (FDA) for the testing of endocervical and urethral swabs and urine specimens. The Amplicor\u00a0N. gonorrhoeae\u00a0PCR target sequence is known to be present in some strains of commensal\u00a0Neisseria\u00a0species, including\u00a0N. cinerea\u00a0and\u00a0N. subflava,\u00a0necessitating the use of a second PCR assay to confirm positive results. This study analyses the performance of the assay on 7,007 unselected specimens submitted to the laboratory for the PCR diagnosis of\u00a0N. gonorrhoeae\u00a0and\u00a0C. trachomatis;\u00a0compares the PCR assay with culture for the detection of\u00a0N. gonorrhoeae;\u00a0examines the performance of the assay with specimens from different body sites; and briefly compares two confirmatory PCR assays. Confirmation rates for an initial Amplicor\u00a0N. gonorrhoeae\u00a0positive result varied widely by specimen type, ranging from 86.2 per cent for penile\/urethral swabs to 5.6 per cent for oropharyngeal swabs, indicating all positive Amplicor\u00a0N. gonorrhoeae\u00a0results should be confirmed by a second method to maintain adequate specificity. Overall there was 98.1 per cent agreement between the confirmed PCR assay and culture, with confirmed PCR showing a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 81.7 per cent, 99.5 per cent, 92.7 per cent and 98.5 per cent respectively, compared with\u00a0N. gonorrhoeae\u00a0culture. When confirmed\u00a0C. trachomatis\/N. gonorrhoeae\u00a0PCR assay performance was analysed against culture using only FDA-cleared specimens (553 penile\/ urethral swabs, urines and cervical\/vaginal swabs), sensitivity, specificity, PPV and NPV and percent agreement were 96.7 per cent, 99.8 per cent, 98.9 per cent, 99.4 per cent and 99.3 per cent respectively. No significant differences were found between the two confirmatory PCR assays used during the study period. Limitations of Amplicor for the detection of\u00a0N. gonorrhoeae\u00a0and the appropriate use of combined\u00a0C. trachomatis\/N. gonorrhoeae\u00a0PCR in a routine diagnostic setting are discussed.\u00a0Commun Dis Intell\u00a02003;27:373-379.<\/jats:p>","DOI":"10.33321\/cdi.2003.27.64","type":"journal-article","created":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T00:43:36Z","timestamp":1749602616000},"page":"373-379","source":"Crossref","is-referenced-by-count":2,"title":["An assessment of the Roche Amplicor\u00ae Chlamydia trachomatis\/Neisseria gonorrhoeae multiplex PCR assay in routine diagnostic use on a variety of specimen types"],"prefix":"10.33321","volume":"27","author":[{"given":"David","family":"Leslie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Franca","family":"Azzato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norbert","family":"Ryan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet","family":"Fyfe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"18788","published-online":{"date-parts":[[2003,9,30]]},"container-title":["Communicable Diseases Intelligence"],"original-title":[],"link":[{"URL":"https:\/\/ojs.cdi.cdc.gov.au\/index.php\/cdi\/article\/download\/2444\/3324","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ojs.cdi.cdc.gov.au\/index.php\/cdi\/article\/download\/2444\/3324","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T00:43:43Z","timestamp":1749602623000},"score":1,"resource":{"primary":{"URL":"https:\/\/ojs.cdi.cdc.gov.au\/index.php\/cdi\/article\/view\/2444"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2003,9,30]]},"references-count":0,"URL":"https:\/\/doi.org\/10.33321\/cdi.2003.27.64","relation":{},"ISSN":["2209-6051"],"issn-type":[{"value":"2209-6051","type":"electronic"}],"subject":[],"published":{"date-parts":[[2003,9,30]]}}}