{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:18:42Z","timestamp":1791919122931,"version":"4.3.4"},"reference-count":14,"publisher":"BMJ","funder":[{"name":"Global AMR Innovation Fund"},{"name":"UK International Development via FIND"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Sex Transm Infect"],"accepted":{"date-parts":[[2026,1,25]]},"abstract":"\n Objectives<\/jats:title>\n \n Neisseria gonorrhoeae<\/jats:italic>\n infection is a global health concern. An affordable and rapid point-of-care test is essential to optimise clinical care and could be used to detect and treat asymptomatic infection. Previously, a novel lateral flow assay for\n N. gonorrhoeae<\/jats:italic>\n infection (NG LFA) met WHO test performance requirements in a symptomatic population. This study aimed to determine the performance of the NG LFA for detection of\n N. gonorrhoeae<\/jats:italic>\n in people without symptoms.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n In this cross-sectional study, we evaluated a novel\n N. gonorrhoeae<\/jats:italic>\n lateral flow assay in urine from 500 asymptomatic men and vaginal swabs from 400 asymptomatic women in South Africa. Individuals visiting four primary healthcare facilities in the Buffalo City district, South Africa were enrolled if they were adults (18\u201349 years) and did not report any genitourinary symptoms, regardless of the reason for visiting the facility. First-void urine specimens and nurse-collected vaginal swabs were tested onsite with the NG-LFA and compared with the Xpert CT\/NG assay. Discordant specimens were further investigated.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Between March and July 2023, we enrolled 500 male and 400 female participants. The median age of male participants was 21 years (range: 18\u201349 years), and female participants, 32 years (range: 18\u201349 years). In urine specimens, NG-LFA sensitivity was 80.6% (Wilson 95%\u2009CI 63.7 to 90.8) and 81.8% in vaginal swab specimens (65\u00b76\u201391.4). The specificity was 94.2% in urine specimens (91.8 to 96.0) and 98.1% in vaginal specimens (96.1 to 99.1). All NG-LFA positive\/Xpert negative cases were negative for\n N. gonorrhoeae<\/jats:italic>\n or other\n Neisseria<\/jats:italic>\n species in additional molecular testing.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The NG LFA in vaginal swab specimens met WHO criteria for a screening test in low-resource settings. The NG LFA in male urine specimens met sensitivity criteria but did not meet the criteria for specificity.<\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/sextrans-2025-056673","type":"journal-article","created":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T18:20:18Z","timestamp":1770661218000},"page":"sextrans-2025-056673","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Cross-sectional evaluation of a lateral flow assay for point-of-care detection of\n Neisseria gonorrhoeae<\/i>\n in asymptomatic individuals at primary healthcare facilities in South Africa"],"prefix":"10.1136","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2124-7275","authenticated-orcid":false,"given":"Remco P H","family":"Peters","sequence":"first","affiliation":[{"name":"Research Unit, Foundation for Professional Development, East London, South Africa"},{"name":"Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa"},{"name":"Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey D","family":"Klausner","sequence":"additional","affiliation":[{"name":"University of Southern California, Keck School of Medicine, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura T","family":"Mazzola","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2795-0343","authenticated-orcid":false,"given":"Mildred Mandisa","family":"Mdingi","sequence":"additional","affiliation":[{"name":"Research Unit, Foundation for Professional Development, East London, South Africa"},{"name":"Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Blumel","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9331-6300","authenticated-orcid":false,"given":"Hyunsul","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ranjana M S","family":"Gigi","sequence":"additional","affiliation":[{"name":"Research Unit, Foundation for Professional Development, East London, South Africa"},{"name":"Department of Social and Preventive Medicine, University of Bern, Bern, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Daniels","sequence":"additional","affiliation":[{"name":"Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsey","family":"De Vos","sequence":"additional","affiliation":[{"name":"Research Unit, Foundation for Professional Development, East London, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2776-6458","authenticated-orcid":false,"given":"Paul C","family":"Adamson","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, University of California Los Angeles, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Birgitta","family":"Gleeson","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cecilia","family":"Ferreyra","sequence":"additional","affiliation":[{"name":"Foundation for Innovative New Diagnostics, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,2,9]]},"reference":[{"key":"2026020910201312000_sextrans-2025-056673v1.1","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.18.228486"},{"key":"2026020910201312000_sextrans-2025-056673v1.2","doi-asserted-by":"crossref","DOI":"10.1002\/jia2.25343","article-title":"Diagnosing sexually transmitted infections in resource-constrained settings: challenges and ways forward","volume":"22 Suppl 6","author":"Wi","year":"2019","journal-title":"J Int AIDS Soc"},{"key":"2026020910201312000_sextrans-2025-056673v1.3","doi-asserted-by":"crossref","unstructured":"Peters RPH , Manguro G , Ong\u2019wen PA , et al . Point-of-care testing to strengthen sexually transmitted infection case management in resource-constrained settings. Sex Transm Infect 2025. doi:10.1136\/sextrans-2025-056833","DOI":"10.1136\/sextrans-2025-056833"},{"key":"2026020910201312000_sextrans-2025-056673v1.4","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0237424","article-title":"Developing target product profiles for Neisseria gonorrhoeae diagnostics in the context of antimicrobial resistance: An expert consensus","volume":"15","author":"Ferreyra","year":"2020","journal-title":"PLoS One"},{"key":"2026020910201312000_sextrans-2025-056673v1.5","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1097\/OLQ.0000000000001913","article-title":"Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care","volume":"51","author":"Gleeson","year":"2024","journal-title":"Sex Transm Dis"},{"key":"2026020910201312000_sextrans-2025-056673v1.6","doi-asserted-by":"crossref","first-page":"657","DOI":"10.1016\/S0140-6736(23)02240-7","article-title":"Novel lateral flow assay for point-of-care detection of Neisseria gonorrhoeae infection in syndromic management settings: a cross-sectional performance evaluation","volume":"403","author":"Peters","year":"2024","journal-title":"Lancet"},{"key":"2026020910201312000_sextrans-2025-056673v1.7","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0286666","article-title":"Usability of a novel lateral flow assay for the point-of-care detection of Neisseria gonorrhoeae: A qualitative time-series assessment among healthcare workers in South Africa","volume":"18","author":"de Vos","year":"2023","journal-title":"PLoS One"},{"key":"2026020910201312000_sextrans-2025-056673v1.8","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2018.23.50.1800253"},{"key":"2026020910201312000_sextrans-2025-056673v1.9","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0205863","article-title":"Adult gonorrhea, chlamydia and syphilis prevalence, incidence, treatment and syndromic case reporting in South Africa: Estimates using the Spectrum-STI model, 1990-2017","volume":"13","author":"Kularatne","year":"2018","journal-title":"PLoS One"},{"key":"2026020910201312000_sextrans-2025-056673v1.10","doi-asserted-by":"crossref","unstructured":"Mukui I , Peacock S , Donnell D , et al . High prevalence and incidence of curable sexually transmitted infections among young women using oral HIV pre-exposure prophylaxis in sub-Saharan Africa: results from the INSIGHT Cohort study. Sex Transm Infect 2025.:sextrans-2025-056625. doi:10.1136\/sextrans-2025-056625","DOI":"10.1136\/sextrans-2025-056625"},{"key":"2026020910201312000_sextrans-2025-056673v1.11","unstructured":"World Health Organization . Point-of-care tests for sexually transmitted infections: target product profiles. 2023. Available: https:\/\/www.who.int\/publications\/i\/item\/9789240077102 [Accessed 8 Jan 2024]."},{"key":"2026020910201312000_sextrans-2025-056673v1.12","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pgph.0003839","article-title":"Evaluation of a novel point-of-care lateral flow assay screening for Neisseria gonorrhoeae infection among pregnant women in Zimbabwe","volume":"5","author":"Martin","year":"2025","journal-title":"PLOS Glob Public Health"},{"key":"2026020910201312000_sextrans-2025-056673v1.13","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1093\/cid\/ciac974","article-title":"Same-Day Treatment Following Point-of-Care Sexually Transmitted Infection Testing in Different Healthcare Settings in South Africa","volume":"76","author":"Mdingi","year":"2023","journal-title":"Clin Infect Dis"},{"key":"2026020910201312000_sextrans-2025-056673v1.14","doi-asserted-by":"crossref","first-page":"2133","DOI":"10.1016\/S0140-6736(25)00983-3","article-title":"Innovations in the biomedical prevention, diagnosis, and service delivery of HIV and other sexually transmitted infections","volume":"406","author":"Peters","year":"2025","journal-title":"Lancet"}],"container-title":["Sexually Transmitted Infections"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/sextrans-2025-056673","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T18:20:20Z","timestamp":1770661220000},"score":1,"resource":{"primary":{"URL":"https:\/\/sti.bmj.com\/lookup\/doi\/10.1136\/sextrans-2025-056673"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,9]]},"references-count":14,"alternative-id":["10.1136\/sextrans-2025-056673"],"URL":"https:\/\/doi.org\/10.1136\/sextrans-2025-056673","relation":{},"ISSN":["1368-4973","1472-3263"],"issn-type":[{"value":"1368-4973","type":"print"},{"value":"1472-3263","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,9]]}}}