{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,25]],"date-time":"2026-03-25T17:48:15Z","timestamp":1774460895096,"version":"3.50.1"},"reference-count":10,"publisher":"BMJ","issue":"6","funder":[{"DOI":"10.13039\/100005258","name":"National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100005258","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006229","name":"Oak Ridge Institute for Science and Education","doi-asserted-by":"publisher","award":["Not applicable"],"award-info":[{"award-number":["Not applicable"]}],"id":[{"id":"10.13039\/100006229","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the field performance of a multiplex PCR (M-PCR) assay for detection of herpes simplex virus (HSV)-1 and HSV-2, <jats:italic>Treponema pallidum<\/jats:italic> (<jats:italic>T. pallidum<\/jats:italic>) and <jats:italic>Haemophilus ducreyi<\/jats:italic> (<jats:italic>H. ducreyi<\/jats:italic>) in genital ulcer disease (GUD) specimens.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>GUD M-PCR was performed on 186 remnant specimens, previously collected for HSV testing, by four public health laboratories (PHLs) and the Laboratory Reference and Research Branch (LRRB) at the Centers for Disease Control and Prevention. The results from the PHLs were compared with those of LRRB, which served as the reference testing method, and percentage agreement was calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>HSV was detected in 31 of 52 (59.6%), 20 of 40 (50%), 43 of 44 (97.7%) and 19 of 50 (38.0%) specimens from PHL1, PHL2, PHL3 and PHL4, respectively. There were seven discrepant results for HSV, and the overall percent agreement between the PHLs and the LRRB was 94%\u2013100%, with a kappa value of 0.922, which demonstrates high agreement. <jats:italic>T. pallidum<\/jats:italic> was identified in 7 of 51 (13.7%) specimens from PHL1 with 94.1% agreement and in 2 of 40 (5.0%) specimens from PHL2 with 100% agreement. The LRRB identified three additional <jats:italic>T. pallidum<\/jats:italic>-positive specimens from PHL1. The kappa value (0.849) for <jats:italic>T. pallidum<\/jats:italic> testing suggests good agreement. Consistent with the LRRB results, no <jats:italic>T. pallidum<\/jats:italic> was detected in specimens from PHL3 and PHL4, and <jats:italic>H. ducreyi<\/jats:italic> was not detected at any of the study sites.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The GUD M-PCR assay performed well in four independent PHLs and 12 suspected syphilis cases were identified in this study. The M-PCR assay could provide improved diagnostic options for GUD infections in state and local PHLs.<\/jats:p><\/jats:sec>","DOI":"10.1136\/sextrans-2021-055081","type":"journal-article","created":{"date-parts":[[2021,12,6]],"date-time":"2021-12-06T18:25:57Z","timestamp":1638815157000},"page":"448-450","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Evaluation of a laboratory-developed multiplex real-time PCR assay for diagnosis of syphilis, herpes and chancroid genital ulcers in four public health laboratories in the USA"],"prefix":"10.1136","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6347-3890","authenticated-orcid":false,"given":"Munegowda","family":"Koralur","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng Y","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allan","family":"Pillay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brunie","family":"White","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin","family":"Pettus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kai-Hua","family":"Chi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joey","family":"Stringer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chukwuemika","family":"Aroh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trivikram","family":"Dasu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjib","family":"Bhattacharyya","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith","family":"Perkins","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jenny","family":"Chen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diana","family":"Riner","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marty","family":"Soehnlen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weiping","family":"Cao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne M","family":"Gaynor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ellen N","family":"Kersh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,12,6]]},"reference":[{"key":"2022101108551051000_98.6.448.1","first-page":"254","article-title":"Diagnosis and management of genital ulcers","volume":"85","author":"Roett","year":"2012","journal-title":"Am Fam Physician"},{"key":"2022101108551051000_98.6.448.2","unstructured":"Centers for Disease Control and Prevention . Sexually transmitted disease surveillance, 2019. Available: https:\/\/www.cdc.gov\/std\/statistics\/2019\/default.htm"},{"key":"2022101108551051000_98.6.448.3","unstructured":"Centers for Disease Control and Prevention . Sexually transmitted disease surveillance 2018. Atlanta: U.S. Department of Health and Human Services, 2019."},{"key":"2022101108551051000_98.6.448.4","doi-asserted-by":"publisher","DOI":"10.1086\/652785"},{"key":"2022101108551051000_98.6.448.5","doi-asserted-by":"crossref","first-page":"S4","DOI":"10.1093\/cid\/ciaa176","article-title":"Molecular and direct detection tests for Treponema pallidum subspecies pallidum: a review of the literature, 1964-2017","volume":"71","author":"Theel","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2022101108551051000_98.6.448.6","unstructured":"FDA . Nucleic acid based tests, 2021. Available: https:\/\/www.fda.gov\/medical-devices\/in-vitro-diagnostics\/nucleic-acid-based-tests [Accessed 7 Sep 2021]."},{"key":"2022101108551051000_98.6.448.7","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-61779-937-2_6"},{"key":"2022101108551051000_98.6.448.8","unstructured":"Quest Diagnostics . Treponema pallidum DNA, qualitative real-time PCR. Available: https:\/\/testdirectory.questdiagnostics.com\/test\/test-detail\/16595\/treponema-pallidum-dna-qualitative-real-time-pcr?cc=MASTER [Accessed 16 Aug 2021]."},{"key":"2022101108551051000_98.6.448.9","unstructured":"Seegene . Allplex\u2122 genital ulcer assay. simultaneous detection of 7 pathogens causing genital ulcer using real-time PCR. Available: https:\/\/www.seegene.com\/assays\/allplex_genital_ulcer_assay [Accessed 6 Jan 2021]."},{"key":"2022101108551051000_98.6.448.10","unstructured":"SpeeDx. PlexPCR\u00ae VHS . Detect and differentiate common lesion-causing pathogens, Herpes simplex virus (HSV-1&-2), Varicella zoster virus (VZV) & Treponema pallidum (Syphilis), in a single-well multiplex qPCR test. Simplify lesion diagnostics. Available: https:\/\/plexpcr.com\/products\/sexually-transmitted-infections\/plexpcr-vhs\/ [Accessed 6 Jan 2021]."}],"container-title":["Sexually Transmitted Infections"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/sextrans-2021-055081","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T15:56:30Z","timestamp":1665503790000},"score":1,"resource":{"primary":{"URL":"https:\/\/sti.bmj.com\/lookup\/doi\/10.1136\/sextrans-2021-055081"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,6]]},"references-count":10,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2022,8,22]]},"published-print":{"date-parts":[[2022,9]]}},"alternative-id":["10.1136\/sextrans-2021-055081"],"URL":"https:\/\/doi.org\/10.1136\/sextrans-2021-055081","relation":{},"ISSN":["1368-4973","1472-3263"],"issn-type":[{"value":"1368-4973","type":"print"},{"value":"1472-3263","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12,6]]}}}