Comparison of Quantamatrix Multiplexed Assay Platform and GenoType MTBDR Assay Using Smear-Positive Sputum Specimens From Patients With Multidrug- Resistant/Extensively Drug-Resistant Tuberculosis in South Korea

Seoyong Kim; Yeun Kim; Yunhee Chang; Workneh Korma Hirgo; Chulhun L Chang; Tae-Sun Shim; Young Uh; Hyeyoung Lee

doi:10.3389/fmicb.2019.01075

Comparison of Quantamatrix Multiplexed Assay Platform and GenoType MTBDR Assay Using Smear-Positive Sputum Specimens From Patients With Multidrug- Resistant/Extensively Drug-Resistant Tuberculosis in South Korea

Front Microbiol. 2019 May 14:10:1075. doi: 10.3389/fmicb.2019.01075. eCollection 2019.

Authors

Seoyong Kim¹, Yeun Kim¹, Yunhee Chang¹, Workneh Korma Hirgo¹, Chulhun L Chang², Tae-Sun Shim³, Young Uh⁴, Hyeyoung Lee¹

Affiliations

¹ Department of Biomedical Laboratory Science, College of Health Sciences, Yonsei University, Wonju, South Korea.
² Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.
³ Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
⁴ Department of Laboratory Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea.

Abstract

Rapid detection of drug-resistant tuberculosis (DR-TB) is crucial for timely treatment and management. The GenoType MTBDRplus and MTBDRsl (MTBDR) assays have been endorsed by the World Health Organization (WHO) for the detection of DR-TB. However, MTBDR assays cannot simultaneously detect multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB). Furthermore, interpretation of the MTBDR assay requires trained people, and the assay has low sample throughput, processing only up to 12 samples in parallel. We have developed the Quantamatrix Multiplexed Assay Platform (QMAP) to detect MDR-/XDR-TB simultaneously. The interpretation of QMAP results is automated, and the platform can process up to 96 samples in parallel. To compare the performance of QMAP with MTBDR assays, we performed QMAP and the MTBDR assay on 76 smear-positive, Mycobacterium tuberculosis culture-positive sputum specimens. Compared with phenotypic drug susceptibility testing (DST) results, the sensitivity and specificity of QMAP were 100 and 98% for rifampin resistance, 80 and 100% for isoniazid resistance, 44.4 and 100% for ethambutol resistance, 100 and 100% for fluoroquinolone resistance, and 100 and 100% for second-line injectable drug resistance, respectively. The sensitivity and specificity of MTBDR assays were 100 and 98% for rifampin resistance, 80 and 100% for isoniazid resistance, 44.4 and 98.1% for ethambutol resistance, 100 and 100% for fluoroquinolone resistance, and 100 and 100% for second-line injectable drug resistance, respectively. The sensitivity and specificity of QMAP were 85.0 and 100%, respectively, for the detection of MDR-TB and 100 and 100%, respectively, for XDR-TB. The sensitivity and specificity of MTBDR assays was consistent with those of QMAP. Our study showed that the QMAP assay has sensitivity and specificity equivalent to that of MTBDR assays in smear-positive sputum specimens. In combination with phenotypic DST, QMAP might be useful as a supplementary DST assay for rapid detection of MDR-/XDR-TB.

Keywords: Mycobacterium tuberculosis; Quantamatrix Multiplexed Assay Platform; drug-resistance; genotype MTBDRplus; genotype MTBDRsl.