{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T07:05:27Z","timestamp":1790665527152,"version":"4.1.0"},"reference-count":9,"publisher":"Microbiology Society","issue":"1","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012737","name":"Department of Health and Human Services, State Government of Victoria","doi-asserted-by":"crossref","award":["VMRAF grant"],"award-info":[{"award-number":["VMRAF grant"]}],"id":[{"id":"10.13039\/100012737","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012737","name":"Department of Health and Human Services, State Government of Victoria","doi-asserted-by":"crossref","award":["VMRAF grant"],"award-info":[{"award-number":["VMRAF grant"]}],"id":[{"id":"10.13039\/100012737","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100012737","name":"Department of Health and Human Services, State Government of Victoria","doi-asserted-by":"crossref","award":["VMRAF grant"],"award-info":[{"award-number":["VMRAF grant"]}],"id":[{"id":"10.13039\/100012737","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"\n Introduction.<\/jats:bold>\n \n \n Mycoplasma genitalium<\/jats:ext-link>\n <\/jats:named-content>\n <\/jats:italic> is a sexually transmitted pathogen with increasing resistance to first- and second-line antimicrobials. The \u2018near-patient test\u2019 ResistancePlus MG FleXible (SpeeDx) detects \n \n M. genitalium<\/jats:ext-link>\n <\/jats:named-content>\n <\/jats:italic> plus four macrolide resistance mutations (MRMs), facilitating same-day patient follow up.<\/jats:p>\n \n Hypothesis\/Gap Statement.<\/jats:bold> This assay has not been assessed on freshly collected samples.<\/jats:p>\n \n Aim.<\/jats:bold> Our goal was to evaluate the performance of the ResistancePlus MG FleXible test against the standard of care open platform test.<\/jats:p>\n \n Methods.<\/jats:bold> ResistancePlus MG FleXible (analysed on the Cepheid GeneXpert platform) was evaluated on freshly collected samples and compared to the standard of care open platform test ResistancePlus MG (SpeeDx) analysed on the LightCycler 480 II (Roche).<\/jats:p>\n \n Results.<\/jats:bold> For 270 valid tests, ResistancePlus MG FleXible yielded a high positive per cent agreement (PPA) of 94.1% [96\/102; 95\u200a% confidence interval (CI): 87.6\u201397.8\u200a%] and negative per cent agreement (NPA) of 95.2% (160\/168; 95\u200a% CI: 90.8\u201397.9%) for \n \n M. genitalium<\/jats:ext-link>\n <\/jats:named-content>\n <\/jats:italic> detection compared to the reference assay (kappa for test concordance of 0.89; 95\u200a% CI: 0.83\u20130.95). Performance was similar across different sample types. For the detection of MRMs, ResistancePlus MG FleXible had a PPA of 97.1% (66\/68; 95% CI: 89.8\u201399.6) and NPA of 78.6% (22\/28; 95\u200a% CI: 59.0\u201391.7), with test comparison kappa of 0.79 (95\u200a% CI: 0.65\u20130.93). Notably, of six discordant results (i.e. determined to be wild type by the reference assay), five were positive for MRMs by Sanger sequencing, indicating that the ResistancePlus MG FleXible assay has an improved performance for mutation detection.<\/jats:p>\n \n Conclusion.<\/jats:bold> ResistancePlus MG FleXible had comparable test performance for \n \n M. genitalium<\/jats:ext-link>\n <\/jats:named-content>\n <\/jats:italic> detection as the open platform assay, with improved detection of MRMs. The ResistancePlus MG FleXible \u2018near-patient\u2019 assay can deliver a rapid result to expedite appropriate treatment.<\/jats:p>","DOI":"10.1099\/jmm.0.001271","type":"journal-article","created":{"date-parts":[[2020,11,23]],"date-time":"2020-11-23T16:33:17Z","timestamp":1606149197000},"source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of ResistancePlus MG FleXible, a \u2018near-patient\u2019 test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples"],"prefix":"10.1099","volume":"70","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3330-4433","authenticated-orcid":false,"given":"Gerald L.","family":"Murray","sequence":"first","affiliation":[{"name":"The Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, Australia"},{"name":"Infection and Immunity Program, Department of Microbiology, Monash Biomedicine Discovery Institute, Monash University, Clayton, VIC, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"},{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0969-2958","authenticated-orcid":false,"given":"Michelle","family":"Doyle","sequence":"additional","affiliation":[{"name":"Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaveesha","family":"Bodiyabadu","sequence":"additional","affiliation":[{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3679-9195","authenticated-orcid":false,"given":"Lenka A.","family":"Vodstrcil","sequence":"additional","affiliation":[{"name":"Central Clinical School, Monash University, Melbourne, VIC, Australia"},{"name":"Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne M.","family":"Garland","sequence":"additional","affiliation":[{"name":"The Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, VIC, Australia"},{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Danielewski","sequence":"additional","affiliation":[{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4101-8085","authenticated-orcid":false,"given":"Dorothy A.","family":"Machalek","sequence":"additional","affiliation":[{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, Australia"},{"name":"The Kirby Institute, University of New South Wales, Sydney, NSW, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7042-9871","authenticated-orcid":false,"given":"Colette","family":"McGuinness","sequence":"additional","affiliation":[{"name":"Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica L.","family":"Plummer","sequence":"additional","affiliation":[{"name":"Central Clinical School, Monash University, Melbourne, VIC, Australia"},{"name":"Centre for Women\u2019s Infectious Diseases, The Royal Women\u2019s Hospital, Parkville, VIC, Australia"},{"name":"Melbourne Sexual Health Centre, Alfred Health, Carlton, VIC, Australia"},{"name":"Molecular Microbiology Research Group, Murdoch Children\u2019s Research Institute, Parkville, VIC, 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