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.

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.

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.

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.

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.

• Authors: Anzaan Dippenaar, Brigitta Derendinger, Tania Dolby, Natalie Beylis, Paul D van Helden, Grant Theron, Robin M Warren, Margaretha de Vos
• Journal: Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases (Clin Microbiol Infect) Vol. 27 Issue 9 Pg. 1351.e1-1351.e4 (Sep 2021) ISSN: 1469-0691 [Electronic] England
• PMID: 33933566 (Publication Type: Comparative Study, Evaluation Study, Journal Article)
• Copyright: Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Antitubercular Agents
• DNA, Bacterial
• Isoniazid
• Rifampin

Topics

• Antitubercular Agents (pharmacology)
• DNA, Bacterial (isolation & purification)
• Drug Resistance, Bacterial
• Humans
• Isoniazid (pharmacology)
• Microbial Sensitivity Tests
• Molecular Diagnostic Techniques
• Mycobacterium tuberculosis (drug effects, genetics)
• Rifampin (pharmacology)
• Sensitivity and Specificity
• Tuberculosis (diagnosis, microbiology)