{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T22:50:25Z","timestamp":1778799025183,"version":"3.51.4"},"reference-count":33,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/doi.org\/10.1128\/ASMCopyrightv2"},{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"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":[[2024,6,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:sec>\n            <jats:title\/>\n            <jats:p>\n              A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM) in 23S rRNA from\n              <jats:italic>Mycoplasmoides genitalium<\/jats:italic>\n              from primary clinical specimens. In this study, MRM-LDT was applied to a multi-specimen source study set. One thousand four hundred ninety-five primary specimens testing positive for\n              <jats:italic>M. genitalium<\/jats:italic>\n              by commercial transcription-mediated amplification (TMA) were initially titered by the TMA assay using serial 10-fold dilutions to semi-quantitate target nucleic acid burden. Primary specimens were then processed for MRM detection using the MRM-LDT. Findings were stratified by gender and specimen source. The mean log\n              <jats:sub>10<\/jats:sub>\n              target nucleic acid titer of a TMA-positive specimen was 3.51 (median 3; range 0\u201310). Male specimens (\n              <jats:italic>n<\/jats:italic>\n              = 1145) demonstrated a mean log\n              <jats:sub>10<\/jats:sub>\n              <jats:italic>M. genitalium<\/jats:italic>\n              TMA titer of 3.67; that value observed in 350 female specimens was 2.98 (\n              <jats:italic>P<\/jats:italic>\n              &lt; 0.0001). The MRM-LDT detection rate (88.7%) from specimens with log\n              <jats:sub>10<\/jats:sub>\n              <jats:italic>M. genitalium<\/jats:italic>\n              TMA titers \u2265 4 was increased over specimens with log\n              <jats:sub>10<\/jats:sub>\n              titers \u2264 1 (4.5%;\n              <jats:italic>P<\/jats:italic>\n              &lt; 0.0002). In females, MRM-LDT was positive from 51.3% of vaginal swab and 34.7% of urine specimens (\n              <jats:italic>P<\/jats:italic>\n              = 0.01). In males, MRM-LDT was positive from 65.0% of rectal swab and 55.7% of urine specimens (\n              <jats:italic>P<\/jats:italic>\n              = 0.002). Differences were also observed in log\n              <jats:sub>10<\/jats:sub>\n              <jats:italic>M. genitalium<\/jats:italic>\n              TMA titers as a function of specimen source.\n              <jats:italic>M. genitalium<\/jats:italic>\n              macrolide resistance rates among multiple specimen sources, as determined by MRM-LDT, are high in the United States and can be consistent with target nucleic acid burden within the primary specimen. Caveats experienced within subgroupings support MRM reflex testing on primary\n              <jats:italic>M. genitalium<\/jats:italic>\n              -positive specimens.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>IMPORTANCE<\/jats:title>\n            <jats:p>\n              First-line macrolide treatment failure is of increasing concern with\n              <jats:italic>Mycoplasmoides genitalium<\/jats:italic>\n              in multiple settings. Recent sexually-transmitted infection treatment guidelines from the United States Centers for Disease Control and Prevention have predicated therapeutic approaches on the availability of a macrolide resistance\/susceptibility result from a primary clinical specimen. In this report, we investigate potential correlation between macrolide resistance mutation detection rates (identified by a molecular amplified laboratory-developed test) and transcription-mediated amplification-based rRNA target semi-quantitation. Data reveal that rRNA semi-quantitation and laboratory-developed test detection rate differences exist as a function of gender and specimen source. These data can guide providers in proper specimen selection not only for the laboratory diagnosis of\n              <jats:italic>M. genitalium<\/jats:italic>\n              but also macrolide resistance mutation determination from primary clinical specimens.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1128\/jcm.00485-24","type":"journal-article","created":{"date-parts":[[2024,5,24]],"date-time":"2024-05-24T13:01:53Z","timestamp":1716555713000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":3,"title":["<i>Mycoplasmoides genitalium<\/i>\n            nucleic acid semi-quantitation and molecular macrolide resistance detection via automated assays: gender and specimen source considerations"],"prefix":"10.1128","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5359-6643","authenticated-orcid":true,"given":"Erik","family":"Munson","sequence":"first","affiliation":[{"name":"Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USA"},{"name":"Wisconsin Clinical Laboratory Network Laboratory Technical Advisory Group, Madison, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Josephine","family":"Moore","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Trinity","family":"Krueger","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amanda","family":"Zapp","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen C.","family":"Lavey","sequence":"additional","affiliation":[{"name":"Loyola University Parkinson School of Health Sciences and Public Health, Maywood, Illinois, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimber L.","family":"Munson","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory Science, Marquette University, Milwaukee, Wisconsin, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene A.","family":"Stafford","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, McGovern Medical School at UTHealth, Houston, Texas, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Mustanski","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA"},{"name":"Institute for Sexual and Gender Minority Health and Wellbeing, Northwestern University, Chicago, Illinois, USA"},{"name":"Department of Medical Social Services, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00006-11"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ312"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.34.2.286-291.1996"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.42.1.203-211.2004"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(83)92212-2"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/sti.61.5.319"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/IAI.00866-17"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00818-17"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00790-21"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02124-19"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-020-04135-9"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01125-19"},{"key":"e_1_3_2_14_2","unstructured":"Centers for Disease Control and Prevention. 2019. 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