Clinical evaluation of the ResistancePlus MG FleXible test on the GeneXpert Infinity-48s instrument: a near-patient assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance
| Autor: | Judit Serra-Pladevall, Yannick Hoyos-Mallecot, Aroa Silgado, María-Jesús Barberá, Miguel Fernández-Huerta, Suhella Tulsiani-Drud, Paula Salmerón, Tomás Pumarola, Mateu Espasa |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Microbiology (medical) 030106 microbiology Mycoplasma genitalium Sensitivity and Specificity 03 medical and health sciences symbols.namesake 0302 clinical medicine Antibiotic resistance 23S ribosomal RNA Drug Resistance Bacterial Prevalence Medicine Humans Mycoplasma Infections 030212 general & internal medicine Sanger sequencing Bacteriological Techniques GeneXpert MTB/RIF biology business.industry General Medicine biology.organism_classification Virology Anti-Bacterial Agents RNA Ribosomal 23S Infectious Diseases Macrolide resistance Molecular Diagnostic Techniques Spain Mutation symbols Population study Macrolides Reagent Kits Diagnostic business Clinical evaluation |
| Zdroj: | Diagnostic microbiology and infectious disease. 97(4) |
| ISSN: | 1879-0070 |
| Popis: | Antibiotic resistance in Mycoplasma genitalium (MG) is rising globally, especially to macrolides. In response to this challenge, assays reporting both the detection of MG and macrolide resistance-mediating mutations (MRMM) allow therapy to be tailored to the individual. The study evaluated the performance of the ResistancePlus® MG FleXible assay for the detection of MG and MRMM. Overall, the test performed well for the detection of MG compared to the AllplexTM STI Essential assay, used as a reference, with a kappa value of 0.926 (95% CI, 0.863-0.990). The kit also performed well for the detection of MRMM when compared with Sanger sequencing of the 23S rRNA gene, with a kappa value of 0.901 (95% CI, 0.807-0.996). The rate of MRMM in MG among the study population was 41.8%. In conclusion, the ResistancePlus® MG FleXible is a rapid, simple, and accurate cartridge-based assay for simultaneous detection of MG and MRMM in clinical settings. |
| Databáze: | OpenAIRE |
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