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The MTB/MDR ELITe MGB(®) Kit: Performance Assessment for Pulmonary, Extra-Pulmonary, and Resistant Tuberculosis Diagnosis, and Integration in the Laboratory Workflow of a French Center

A rapid and reliable diagnostic for tuberculosis, including the detection of both rifampicin (RIF) and isoniazid (INH) resistance, is essential for appropriate patient care. Nucleic acid amplification tests are a fast alternative to methods based on Mycobacterium tuberculosis complex (MTB) cultures....

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Detalles Bibliográficos
Autores principales: Hodille, Elisabeth, Genestet, Charlotte, Delque, Thomas, Ruffel, Luna, Benito, Yvonne, Fredenucci, Isabelle, Rasigade, Jean-Philippe, Lina, Gérard, Dumitrescu, Oana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914564/
https://www.ncbi.nlm.nih.gov/pubmed/33561935
http://dx.doi.org/10.3390/pathogens10020176
Descripción
Sumario:A rapid and reliable diagnostic for tuberculosis, including the detection of both rifampicin (RIF) and isoniazid (INH) resistance, is essential for appropriate patient care. Nucleic acid amplification tests are a fast alternative to methods based on Mycobacterium tuberculosis complex (MTB) cultures. Thus, the performance of the MDR/MTB ELITe MGB(®) Kit on the ELITe InGenius(®) platform was retrospectively evaluated for MTB detection on pulmonary and extra-pulmonary samples and for RIF/INH resistance detection on MTB strains. The sensitivity and specificity of the kit for MTB detection compared to the MTB culture were 80.0% and 100.0%, respectively. For the antimicrobial susceptibility prediction, the agreement with phenotypic antimicrobial susceptibility testing (AST) was 92.0%. For RIF, the sensitivity was 100.0% and the specificity was 95.5%. For INH, the sensitivity and specificity were 75.0% and 100.0%, respectively. A single RIF false-positive result was obtained for a strain with a low level of RIF resistance that was not detected by phenotypic AST, but carrying a rpoB L452P mutation. INH false-negative results (3) were due to mutations on the katG gene that were not probed by the test. Overall, the MTB/MDR ELITe MGB(®) Kit presents a strong performance for MTB detection and for the detection of both RIF and INH resistance, with an easy integration in laboratory workflow thanks to its fully automatized system.