The MDR/MTB ELITe MGB kit (ELITech) carried on the ELITe InGenius platform is a new real-time PCR assay allowing automated extraction and detection of DNA of the complex (MTB) and mutations in the and genes and promoter region (pro-) associated to resistance to rifampicin and isoniazid, the two markers of multidrug-resistant TB (MDR). We assessed the performances of the test on a collection of strains ( = 54) and a set of clinical samples ( = 242) from routine practice, comparatively to TB diagnosis and genotypic drug susceptibility testing (gDST) as references. Regarding the 242 clinical samples, the sensitivity and specificity of MTB detection by ELITe were 90.9% and 97.5%, respectively. For the detection of resistance-conferring mutations on positive clinical samples, we observed perfect agreement with gDST for and pro- (κ = 1.0) and two discordant results for (κ = 0.82). Considering the 54 cultured strains, very good agreement with gDST was observed for the detection of the 25 distinct mutations in , , and pro-, (κ = 0.95, 0.88, and 0.95, respectively). In conclusion, the automated MDR/MTB ELITe MGB assay shows great promise and appears to be a valuable tool for rapid detection of pre-MDR- and MDR-TB directly from clinical specimens.
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http://dx.doi.org/10.3390/antibiotics10070797 | DOI Listing |
Antibiotics (Basel)
June 2021
Centre d'Immunologie et des Maladies Infectieuses, Sorbonne Université, INSERM, U1135, Cimi-Paris, F-75013 Paris, France.
The MDR/MTB ELITe MGB kit (ELITech) carried on the ELITe InGenius platform is a new real-time PCR assay allowing automated extraction and detection of DNA of the complex (MTB) and mutations in the and genes and promoter region (pro-) associated to resistance to rifampicin and isoniazid, the two markers of multidrug-resistant TB (MDR). We assessed the performances of the test on a collection of strains ( = 54) and a set of clinical samples ( = 242) from routine practice, comparatively to TB diagnosis and genotypic drug susceptibility testing (gDST) as references. Regarding the 242 clinical samples, the sensitivity and specificity of MTB detection by ELITe were 90.
View Article and Find Full Text PDFPathogens
February 2021
Laboratoire des Mycobactéries, Hospices Civils de Lyon, Hôpital de la Croix-Rousse, Centre de Biologie Nord, Institut des Agents Infectieux, 69004 Lyon, France.
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 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.
View Article and Find Full Text PDFPLoS One
August 2020
Microbiology Unit-Department of Experimental, Diagnostic and Specialty Medicine, S. Orsola-Malpighi University Hospital, Bologna, Italy.
The MDR/MTB ELITe MGB® Kit on the ELITe InGenius® platform (ELITechGroup SpA, Italy) is the first system for simultaneous detection of the Mycobacterium tuberculosis complex (MTBc) genome and the main mutations responsible for resistance to Isoniazid (inhA, katG) and Rifampicin (rpoB), from decontaminated and heat inactivated samples. In this study we compared the performance of the MDR/MTB ELITe MGB® Kit (ELITe) with culture in 100 pulmonary and 160 extra-pulmonary samples. The sensitivity and specificity of ELITe compared to culture for pulmonary samples were 98.
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