{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T01:04:30Z","timestamp":1785546270004,"version":"3.56.0"},"reference-count":44,"publisher":"American Society for Microbiology","issue":"7","license":[{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T00:00:00Z","timestamp":1721088000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2024,7,16]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              Home sample collection for sexually transmitted infection (STI) screening options can improve access to sexual healthcare across communities. For\n              <jats:italic>Chlamydia trachomatis<\/jats:italic>\n              (CT) and\n              <jats:italic>Neisseria gonorrhoeae<\/jats:italic>\n              (NG), genital infections have classically been the focus for remote collection options. However, infections may go undiagnosed if sampling is limited to urogenital sites because some individuals only participate in oral and\/or anal intercourse. Here we evaluated samples for CT\/NG detection after several pre-analytical collection challenges. A paired provider to self-collection validation was performed on rectal [\n              <jats:italic>n<\/jats:italic>\n              = 162; 22 + for CT and 9 + for NG by provider-collected (PC)] and throat (\n              <jats:italic>N<\/jats:italic>\n              = 158; 2 + for CT and 11 + for NG by provider-collected) swabs. The positive percent agreement for CT and NG ranged from 90.9% to 100%. The discrepancies were more often positive on self-collected (SC) (\n              <jats:italic>n<\/jats:italic>\n              = 9 SC+\/PC\u2212;\n              <jats:italic>n<\/jats:italic>\n              = 1 PC+\/SC\u2212;\n              <jats:italic>n<\/jats:italic>\n              = 1 PC+\/SC Equiv.;\n              <jats:italic>n<\/jats:italic>\n              = 2 PC\u2212\/SC Equiv.). An empirical limit of detection (LoD) lower than the manufacturer\u2019s claim (0.031 vs 2.5 IFU\/mL for CT and 0.063 vs 124.8 CFU\/ml for NG, respectively) was used to challenge additional variables. Common hand contaminants, including soap, hand sanitizer, lotion, and sunscreen were added to known positive (3\u00d7 empirical LoD) or negative samples and did not influence detection. Samples at 2\u00d7 and 10\u00d7 the empirical LoD were challenged with extreme temperature cycling and extended room temperature storage. Detection was not affected by these conditions. These results indicate that remote self-collection is an appropriate method of sample acquisition for detecting extragenital CT\/NG infections. Additionally, they provide a foundation towards meeting the regulatory standards for commercial testing of home collected extragenital samples.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>There is a clinical need for expanded extragenital bacterial sexually transmitted infection (STI) testing options, but the current regulatory landscape limits the wide-spread promotion and adoption of such services. Improved access, particularly for the LGBTQ+ community, can be achieved by validating testing for specimens that are self-collected at a remote location and arrive at the laboratory via a postal carrier or other intermediary route. Here we provide valuable data showing that self-collected samples for anal and oropharyngeal STI testing are equally or increasingly sensitive compared with those collected by a provider. We systematically consider the effects of storage time, exposure to temperature extremes, and the addition of common toiletries on results.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.00311-24","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T12:16:21Z","timestamp":1717589781000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":7,"title":["Overcoming analytical and preanalytical challenges associated with extragenital home collected STI specimens"],"prefix":"10.1128","volume":"62","author":[{"given":"B. E.","family":"Hockman","sequence":"first","affiliation":[{"name":"LetsGetChecked Laboratories, Monrovia, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Qi","sequence":"additional","affiliation":[{"name":"LetsGetChecked Laboratories, Monrovia, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Rotblatt","sequence":"additional","affiliation":[{"name":"Los Angeles County Department of Public Health Division of HIV and STD Programs, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Borenstein","sequence":"additional","affiliation":[{"name":"Los Angeles County Department of Public Health Laboratory, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. A.","family":"Flynn","sequence":"additional","affiliation":[{"name":"Los Angeles LGBT Center Clinic, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. A.","family":"Muldrow","sequence":"additional","affiliation":[{"name":"LetsGetChecked Laboratories, Monrovia, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Rajagopalan","sequence":"additional","affiliation":[{"name":"Los Angeles County Department of Public Health Division of HIV and STD Programs, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6966-9904","authenticated-orcid":true,"given":"D. N.","family":"Greene","sequence":"additional","affiliation":[{"name":"LetsGetChecked Laboratories, Monrovia, California, USA"},{"name":"Laboratory Medicine and Pathology, University of Washington, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181a44b8c"},{"key":"e_1_3_4_4_2","first-page":"70","article-title":"How reliable is self-testing for gonorrhea and chlamydia among men who have sex with men?","volume":"62","author":"Sexton ME","year":"2013","unstructured":"Sexton ME, Baker JJ, Nakagawa K, Li Y, Perkins R, Slack RS, Baker DC, Jucha B, Arora S, Plankey MW. 2013. How reliable is self-testing for gonorrhea and chlamydia among men who have sex with men? J Fam Pract 62:70\u201378.","journal-title":"J Fam Pract"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1177\/0956462417744098"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2018-053835"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-017-2332-x"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000917"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000754"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/5758387"},{"key":"e_1_3_4_11_2","unstructured":"STD facts - STD risk and oral sex. 2022. Available from: https:\/\/www.cdc.gov\/std\/healthcomm\/stdfact-stdriskandoralsex.htm. Retrieved 10 Jan 2024."},{"key":"e_1_3_4_12_2","unstructured":"Detailed STD facts - Gonorrhea. 2023. Available from: https:\/\/www.cdc.gov\/std\/gonorrhea\/stdfact-gonorrhea-detailed.htm. 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