{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T07:04:31Z","timestamp":1790665471148,"version":"4.1.0"},"reference-count":28,"publisher":"American Society for Microbiology","issue":"11","license":[{"start":{"date-parts":[[2017,10,24]],"date-time":"2017-10-24T00:00:00Z","timestamp":1508803200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2017,11,1]],"date-time":"2017-11-01T00:00:00Z","timestamp":1509494400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Hologic, Inc","award":["AST CT 2016-387"],"award-info":[{"award-number":["AST CT 2016-387"]}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            The aim of this study was to evaluate the clinical performance of the Aptima\n            <jats:named-content content-type=\"genus-species\">Mycoplasma genitalium<\/jats:named-content>\n            transcription-mediated amplification (MG-TMA) CE-marked for\n            <jats:italic>in vitro<\/jats:italic>\n            diagnosis (CE-IVD) assay for the detection of\n            <jats:named-content content-type=\"genus-species\">Mycoplasma genitalium<\/jats:named-content>\n            in male and female clinical samples in comparison with the in-house real-time PCR (in-house PCR) assay routinely used in our laboratory. A total of 1,431 clinical specimens obtained from 1,235 patients were prospectively collected at the Bacteriology Department of Bordeaux University Hospital (France). Additional research-use-only Aptima\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            transcription-mediated amplification (TMA) assays, Alt1-TMA and Alt2-TMA, were performed on discordant specimens to determine\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            infection status. All confirmed\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            -positive specimens were tested for macrolide resistance using three assays: the in-house 23S rRNA FRET PCR assay, the SpeeDx ResistancePlus MG assay and the nested reverse transcription-PCR (RT-PCR) sequencing assay. The comparison of the MG-TMA assay with the in-house PCR results showed a moderate correlation (kappa value, 0.69). The MG-TMA assay had higher clinical sensitivity compared to that of the in-house PCR assay (100% versus 59.74%, respectively) and similar specificity (99.10% versus 100%, respectively) for\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            detection. In this study, the prevalence of\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            infection was 5.90% (72\/1,220 patients). The nested RT-PCR sequencing assay was the most sensitive but the most laborious assay for detecting macrolide-resistance-associated mutations. The prevalence of resistance was 8.33% (6\/72). To our knowledge, this is the first clinical evaluation of the MG-TMA CE-IVD assay. The MG-TMA assay performed on the automated Panther system is a very sensitive and specific method for the detection of\n            <jats:named-content content-type=\"genus-species\">M. genitalium<\/jats:named-content>\n            in clinical specimens.\n          <\/jats:p>","DOI":"10.1128\/jcm.00579-17","type":"journal-article","created":{"date-parts":[[2017,8,10]],"date-time":"2017-08-10T00:40:15Z","timestamp":1502325615000},"page":"3194-3200","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":38,"title":["French Prospective Clinical Evaluation of the Aptima Mycoplasma genitalium CE-IVD Assay and Macrolide Resistance Detection Using Three Distinct Assays"],"prefix":"10.1128","volume":"55","author":[{"given":"Chlo\u00e9","family":"Le Roy","sequence":"first","affiliation":[{"name":"Univ. Bordeaux, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"INRA, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Pereyre","sequence":"additional","affiliation":[{"name":"Univ. Bordeaux, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"INRA, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"CHU Bordeaux, Laboratoire de Bact\u00e9riologie, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nad\u00e8ge","family":"H\u00e9nin","sequence":"additional","affiliation":[{"name":"Univ. Bordeaux, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"INRA, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C\u00e9cile","family":"B\u00e9b\u00e9ar","sequence":"additional","affiliation":[{"name":"Univ. Bordeaux, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"INRA, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France"},{"name":"CHU Bordeaux, Laboratoire de Bact\u00e9riologie, Bordeaux, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1177\/0956462413515196"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.medmal.2012.05.006"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00006-11"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.42.2.683-692.2004"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.mimet.2012.03.009"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02567-13"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10156-011-0362-7"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01038-16"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0156740"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/apm.12430"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01053-16"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00553-06"},{"key":"e_1_3_3_14_2","first-page":"289","volume-title":"Mollicutes: molecular biology and pathogenesis","author":"Waites KB","year":"2014","unstructured":"Waites KB Lysnyansky I B\u00e9b\u00e9ar CM . 2014. Emerging antimicrobial resistance in mycoplasmas of humans and animals, p 289\u2013322. InBrowningGFCittiC (ed), Mollicutes: molecular biology and pathogenesis. 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