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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
The diagnostic performance of the GenoType MTBDRplus version 2 line probe assay is equivalent to that of the Xpert MTB/RIF assay
Journal of Clinical Microbiology, Volume 50, No. 11, Year 2012
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Description
Molecular diagnostics for Mycobacterium tuberculosis have recently been endorsed by the World Health Organization. The Xpert MTB/RIF assay was endorsed for use on patient material, regardless of smear gradation, while the GenoType MTBDRplus (version 1) has been limited for use on smear-positive patient material. In this study, we evaluated the diagnostic performance of the Xpert MTB/RIF and GenoType MTBDRplus (version 2) assays on smear-positive and smear-negative patient specimens submitted to a high-throughput diagnostic laboratory. A total of 282 consecutive specimens were subjected to the two new molecular assays, and their performance characteristics were assessed relative to the routine diagnostic standard. Both assays showed similar diagnostic performance characteristics. The sensitivities of the GenoType MTBDRplus (v2.0) and Xpert MTB/RIF assays for the detection of culture-positive M. tuberculosis were 73.1% and 71.2%, respectively, while the specificities of both assays were 100%. Both assays were able to diagnose the presence of M. tuberculosis in 57 to 58% of smear-negative cases, suggesting that the performance characteristics were dependent on bacillary load. The detection of M. tuberculosis in culture-negative specimens confirmed that molecular assays should not be used for treatment monitoring. The sensitivity and specificity for rifampin resistance detection were 100% in both assays; however, the GenoType MTBDRplus (v2.0) assay provided additional information on isoniazid susceptibility. The GenoType MTBDRplus (v2.0) assay will complement the Xpert MTB/RIF screening assay by validating rifampin susceptibility and providing information on isoniazid susceptibility. In addition, the GenoType MTBDRplus (v2.0) assay will provide pharmacogenetic information that may be critical in guiding appropriate treatment. Copyright © 2012, American Society for Microbiology. All Rights Reserved.
Authors & Co-Authors
Barnard, Marinus
South Africa, Johannesburg
National Health Laboratory Service
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Gey van Pittius, Nicolaas Claudius
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Van Helden, Paul D.
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Bosman, Marleine E.
South Africa, Johannesburg
National Health Laboratory Service
Coetzee, Gerrit J.
South Africa, Johannesburg
National Health Laboratory Service
Warren, Robin Mark
South Africa, Cape Town
Stellenbosch University, Faculty of Medicine and Health Sciences
Statistics
Citations: 116
Authors: 6
Affiliations: 2
Identifiers
Doi:
10.1128/JCM.01958-12
ISSN:
00951137
e-ISSN:
1098660X
Research Areas
Genetics And Genomics
Health System And Policy