{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T18:34:44Z","timestamp":1792002884616,"version":"4.4.0"},"reference-count":10,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2023,4,27]],"date-time":"2023-04-27T00:00:00Z","timestamp":1682553600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Roche Molecular Systems","award":["Study number: RD005106"],"award-info":[{"award-number":["Study number: RD005106"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2023,4,1]]},"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the clinical performance of the novel PivNG primers and probes set (PivNG test) used in the cobas omni Utility Channel for supplemental testing of<jats:italic>Neisseria gonorrhoeae<\/jats:italic>(NG).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Oropharyngeal, urogenital and rectal samples were self-collected during routine testing at Barts Health sexual health clinics, London, UK. Samples were tested by the cobas CT\/NG test and PivNG cobas omni Utility Channel test on cobas 6800\/8800 Systems. Supplemental testing was carried out with the Xpert CT\/NG test. PivNG overall percent agreements, positive percent agreements (PPAs)\/negative percent agreements (NPAs) and positive\/negative predictive values were calculated for each sample type. Microscopy and\/or culture data were included for a randomised subset of concordant\/discordant results, and a composite reference standard (cobas CT\/NG, Xpert CT\/NG and culture results) adjusted for partial verification bias was used to determine PivNG PPA and NPA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 447 evaluable samples with valid results from all three assays (cobas CT\/NG, PivNG and Xpert CT\/NG), 288 (64.4%) were NG-positive by both PivNG and cobas CT\/NG; 117 (26.2%) were NG-negative in both tests; and 42 (9.4%) had discordant results (with NG-negative supplementary Xpert) CT\/NG results in 40\/42 instances). Of 19 PivNG\/Xpert CT\/NG-discordant samples, 11 were confirmed NG-positive by microscopy and\/or culture results. PivNG PPA and NPA were 100% and 91% for oropharyngeal swabs, 100% and 100% for vaginal swabs, 100% and 100% for male urine samples, and 100% and 97% for rectal swabs, respectively, compared with the partially adjusted composite reference standard.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>PivNG is a reliable supplementary test with high sensitivity for confirming NG infection when used in conjunction with the cobas CT\/NG test and samples collected in cobas PCR Media. Moreover, the PivNG test offers a convenient, high-throughput solution for supplemental NG testing of various sample types, with the potential to reduce the number of indeterminate reports.<\/jats:p><\/jats:sec>","DOI":"10.1136\/sextrans-2022-055576","type":"journal-article","created":{"date-parts":[[2023,4,28]],"date-time":"2023-04-28T17:21:43Z","timestamp":1682702503000},"page":"416-419","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["PivNG primers and probes set used in the cobas omni Utility Channel is a reliable supplemental test for detection of<i>Neisseria gonorrhoeae<\/i>in oropharyngeal, urogenital and rectal specimens collected in cobas PCR Media"],"prefix":"10.1136","volume":"99","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4744-8542","authenticated-orcid":false,"given":"Mark","family":"Hopkins","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodney","family":"Arcenas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xose","family":"Couto-Parada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lewinski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merlin","family":"Njoya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deva","family":"Perinpanathan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rizwaan","family":"Sheriff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avneet","family":"Hansra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Selena","family":"Singh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,4,28]]},"reference":[{"key":"2024102610500794000_99.6.416.1","unstructured":"WHO . Sexually transmitted infections (STIs). 2021. Available: https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/sexually-transmitted-infections-(stis)"},{"key":"2024102610500794000_99.6.416.2","doi-asserted-by":"crossref","DOI":"10.3390\/pathogens9020091","article-title":"The laboratory diagnosis of Neisseria gonorrhoeae: current testing and future demands","volume":"9","author":"Meyer","year":"2020","journal-title":"Pathogens"},{"key":"2024102610500794000_99.6.416.3","doi-asserted-by":"publisher","DOI":"10.1177\/0956462419886775"},{"key":"2024102610500794000_99.6.416.4","unstructured":"England Public Health . Guidance for the detection of gonorrhoea in england. 2021. Available: https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/972388\/Guidance_for_the_detection_of_gonorrhoea_in_England_2021.pdf"},{"key":"2024102610500794000_99.6.416.5","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1556\/1886.2017.00018","article-title":"High-throughput testing of urogenital and extragenital specimens for detection of Chlamydia trachomatis and Neisseria gonorrhoeae with cobas\u00ae CT\/NG","volume":"7","author":"Marlowe","year":"2017","journal-title":"Eur J Microbiol Immunol (Bp)"},{"key":"2024102610500794000_99.6.416.6","unstructured":"Integrated DNA Technologies . Microbial identification assays. 2022. Available: https:\/\/eu.idtdna.com\/pages\/products\/reagents-and-kits\/microbial-detection\/microbial-identification-assays"},{"key":"2024102610500794000_99.6.416.7","doi-asserted-by":"crossref","DOI":"10.1128\/JCM.01996-18","article-title":"Evaluation of the performance of the cobas CT\/NG test for use on the COBAS 6800\/8800 systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in male and female urogenital samples","volume":"57","author":"Van Der Pol","year":"2019","journal-title":"J Clin Microbiol"},{"key":"2024102610500794000_99.6.416.8","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2013-051410"},{"key":"2024102610500794000_99.6.416.9","doi-asserted-by":"publisher","DOI":"10.2353\/jmoldx.2006.050045"},{"key":"2024102610500794000_99.6.416.10","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01976-14"}],"container-title":["Sexually Transmitted Infections"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/sextrans-2022-055576","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,26]],"date-time":"2024-10-26T17:50:24Z","timestamp":1729965024000},"score":1,"resource":{"primary":{"URL":"https:\/\/sti.bmj.com\/lookup\/doi\/10.1136\/sextrans-2022-055576"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,4,28]]},"references-count":10,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,8,17]]},"published-print":{"date-parts":[[2023,9]]}},"alternative-id":["10.1136\/sextrans-2022-055576"],"URL":"https:\/\/doi.org\/10.1136\/sextrans-2022-055576","relation":{},"ISSN":["1368-4973","1472-3263"],"issn-type":[{"value":"1368-4973","type":"print"},{"value":"1472-3263","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,4,28]]}}}