{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T18:45:14Z","timestamp":1792176314914,"version":"4.4.0"},"reference-count":34,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:00:00Z","timestamp":1791849600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["K23AI182453"],"award-info":[{"award-number":["K23AI182453"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Int J STD AIDS"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Few studies have evaluated the field performance of novel point-of-care molecular assays for\n                      <jats:italic toggle=\"yes\">Chlamydia trachomatis<\/jats:italic>\n                      and\n                      <jats:italic toggle=\"yes\">Neisseria gonorrhoeae<\/jats:italic>\n                      . We aimed to assess the performance, feasibility and acceptability of the prototype OraSure CT\/NG assay (InteliQuick, OraSure Technologies Inc., USA) among clinics in Peru.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Between May and June 2025, we recruited men and women from three clinics in Lima. Participants self-collected rectal and vaginal or penile meatal swabs and provided urine samples, while clinic staff collected pharyngeal swabs. We compared results of the prototype OraSure CT\/NG assay with reference testing using the Xpert CT\/NG assay (Cepheid, USA) on rectal, pharyngeal, and vaginal swabs as well as male urine, and the Aptima Combo 2 CT\/NG assay (Hologic, USA) on penile meatal swabs and male urine. We applied an intention-to-diagnose framework, calculating explanatory scientific accuracy, which permits repeat testing on invalid specimens, and pragmatic application accuracy which classifies invalid results as false positives or negatives. We calculated the positive (PPA) and negative percent agreement (NPA) for each anatomic site and used closed-ended surveys to assess acceptability and feasibility among laboratory personnel.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      We enrolled 157 participants. Of 470 specimens tested by the OraSure CT\/NG assay, 92.3% yielded a valid result on the first attempt (99.1% after repeated testing). Among symptomatic participants, PPA for\n                      <jats:italic toggle=\"yes\">N. gonorrhoeae<\/jats:italic>\n                      was 100.0% (penile meatal), 72.7% (pharyngeal), and 69.2% (rectal), while for\n                      <jats:italic toggle=\"yes\">C. trachomatis<\/jats:italic>\n                      the PPA was 50.0% (penile meatal), 33.3% (pharyngeal), and 85.7% (rectal). NPA remained &gt;90% across all sites. Seven of eight clinic laboratory personnel rated the assay as easy to use and compatible with existing clinic workflows.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The OraSure CT\/NG assay showed consistently high NPA and was acceptable to users, while the PPA varied by pathogen and specimen type.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/09564624261496936","type":"journal-article","created":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T07:35:22Z","timestamp":1791876922000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Field Performance and usability of a novel molecular point-of-care assay for\n                    <i>C<\/i>\n                    <i>hlamydia trachomatis<\/i>\n                    and\n                    <i>Neisseria gonorrhoeae<\/i>\n                    detection"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-6466-1811","authenticated-orcid":false,"given":"Francesca","family":"Vasquez","sequence":"first","affiliation":[{"name":"Universidad Peruana Cayetano Heredia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacklynn","family":"Okereke","sequence":"additional","affiliation":[{"name":"Harvard University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silver K.","family":"Vargas","sequence":"additional","affiliation":[{"name":"Universidad Peruana Cayetano Heredia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelika A.","family":"Konda","sequence":"additional","affiliation":[{"name":"Universidad Peruana Cayetano Heredia"},{"name":"University of Southern California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E. Michael","family":"Reyes-Diaz","sequence":"additional","affiliation":[{"name":"Universidad Peruana Cayetano Heredia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najla","family":"Refat","sequence":"additional","affiliation":[{"name":"\u00d6rebro University"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magnus","family":"Unemo","sequence":"additional","affiliation":[{"name":"\u00d6rebro University"},{"name":"University College London (UCL)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6922-7364","authenticated-orcid":false,"given":"Jeffrey D.","family":"Klausner","sequence":"additional","affiliation":[{"name":"University of Southern California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4077-3476","authenticated-orcid":false,"given":"Lao-Tzu","family":"Allan-Blitz","sequence":"additional","affiliation":[{"name":"Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, USA"},{"name":"University of California Los Angeles"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,13]]},"reference":[{"key":"e_1_3_8_2_2","volume-title":"Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum (syphilis), and new recommendations on syphilis testing and partner services","author":"World Health Organization","year":"2024","unstructured":"World Health Organization. Updated recommendations for the treatment of Neisseria gonorrhoeae, Chlamydia trachomatis and Treponema pallidum (syphilis), and new recommendations on syphilis testing and partner services. World Health Organization, 2024. Available at: https:\/\/www.who.int\/publications\/i\/item\/9789240090767 (accessed 5 March 2026)."},{"key":"e_1_3_8_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)02240-7"},{"key":"e_1_3_8_4_2","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-052950"},{"key":"e_1_3_8_5_2","doi-asserted-by":"publisher","DOI":"10.1080\/14737159.2021.1952074"},{"key":"e_1_3_8_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11904-025-00736-1"},{"key":"e_1_3_8_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2025-056673"},{"key":"e_1_3_8_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/1751-7915.70153"},{"key":"e_1_3_8_9_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkac242"},{"key":"e_1_3_8_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/msphere.00677-24"},{"key":"e_1_3_8_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30734-9"},{"key":"e_1_3_8_12_2","doi-asserted-by":"publisher","DOI":"10.1089\/lgbt.2014.0056"},{"key":"e_1_3_8_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01171-20"},{"key":"e_1_3_8_14_2","doi-asserted-by":"publisher","DOI":"10.1097\/QCO.0000000000000585"},{"key":"e_1_3_8_15_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-019-41963-y"},{"key":"e_1_3_8_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11904-025-00728-1"},{"key":"e_1_3_8_17_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000001457"},{"key":"e_1_3_8_18_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2016-012799"},{"key":"e_1_3_8_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-024-09019-3"},{"key":"e_1_3_8_20_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0286666"},{"key":"e_1_3_8_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(25)00070-2"},{"key":"e_1_3_8_22_2","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2023.1067554"},{"key":"e_1_3_8_23_2","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2025-056613"},{"key":"e_1_3_8_24_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2016.07.018"},{"key":"e_1_3_8_25_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-55241-z"},{"key":"e_1_3_8_26_2","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.rr7004a1"},{"key":"e_1_3_8_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.lanmic.2025.101214"},{"key":"e_1_3_8_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2352-3018(23)00299-0"},{"key":"e_1_3_8_29_2","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.15569.4"},{"key":"e_1_3_8_30_2","unstructured":"Centers for Disease Control and Prevention. CDC\u2019s 2019 antibiotic resistance threats report: drug-resistant Neisseria gonorrhoeae. Available at: https:\/\/stacks.cdc.gov (2019) (accessed 5 March 2026)."},{"key":"e_1_3_8_31_2","volume-title":"Enhanced gonococcal antimicrobial surveillance programme (EGASP): gonorrhoea treatment optimization, 2025 report","author":"World Health Organization","year":"2025","unstructured":"World Health Organization. Enhanced gonococcal antimicrobial surveillance programme (EGASP): gonorrhoea treatment optimization, 2025 report. World Health Organization, 2025. Available at: https:\/\/iris.who.int\/server\/api\/core\/bitstreams\/ed59e063-8034-4886-8fd5-41785ee836d6\/content (accessed 5 March 2026)."},{"key":"e_1_3_8_32_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12913-023-10478-8"},{"key":"e_1_3_8_33_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0215380"},{"key":"e_1_3_8_34_2","volume-title":"Point-of-care tests for sexually transmitted infections: target product profiles","author":"World Health Organization","year":"2023","unstructured":"World Health Organization. Point-of-care tests for sexually transmitted infections: target product profiles. World Health Organization, 2023. Available at: https:\/\/www.who.int\/publications\/i\/item\/9789240077102 (accessed 14 August 2026)."},{"key":"e_1_3_8_35_2","volume-title":"Consolidated guidelines on HIV testing services, 2019","author":"World Health Organization","year":"2020","unstructured":"World Health Organization. Consolidated guidelines on HIV testing services, 2019. 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