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Diagnostic accuracy of the FluoroType MTB and MTBDR VER 2.0 assays for the centralized high-throughput detection of Mycobacterium tuberculosis complex DNA and isoniazid and rifampicin resistance.

Authors :
Dippenaar A
Derendinger B
Dolby T
Beylis N
van Helden PD
Theron G
Warren RM
de Vos M
Source :
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2021 Sep; Vol. 27 (9), pp. 1351.e1-1351.e4. Date of Electronic Publication: 2021 Apr 30.
Publication Year :
2021

Abstract

Objectives: To evaluate the accuracy of two new molecular diagnostic tests for the detection of drug-resistant tuberculosis, the FluoroType MTB and MTBDR VER 2.0 assays, in combination with manual and automated DNA extraction methods.<br />Methods: Sputa from 360 Xpert Ultra Mycobacterium tuberculosis complex (MTBC)-positive patients and 250 Xpert Ultra MTBC-negative patients were tested. GenoType MTBDRplus served as reference for MTBC and drug resistance detection. Sanger sequencing was used to resolve discrepancies.<br />Results: FluoroType MTB VER 2.0 showed similar MTBC sensitivity compared with FluoroType MTBDR VER 2.0 (manual DNA extraction: 91.6% (294/321) versus 89.8% (291/324); p 0.4); automated DNA extraction: 92.1% (305/331) versus 87.7% (291/332); p 0.05)). FluoroType MTBDR VER2.0 showed comparable diagnostic accuracy to FluoroType MTBDR VER1.0 as previously reported for the detection of MTBC and rifampicin and isoniazid resistance.<br />Conclusions: The FluoroType MTB and MTBDR VER 2.0 assays together with an automated DNA extraction and PCR set-up platform may improve laboratory operational efficiency for the diagnosis of MTBC and resistance to rifampicin and isoniazid and show promise for the implementation in a centralized molecular drug susceptibility testing model.<br /> (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Details

Language :
English
ISSN :
1469-0691
Volume :
27
Issue :
9
Database :
MEDLINE
Journal :
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
Publication Type :
Academic Journal
Accession number :
33933566
Full Text :
https://doi.org/10.1016/j.cmi.2021.04.022