Ann Lab Med.  2018 Nov;38(6):569-577. 10.3343/alm.2018.38.6.569.

Detection of Rifampicin- and Isoniazid-Resistant Mycobacterium tuberculosis Using the Quantamatrix Multiplexed Assay Platform System

• Wang HY
• Uh Y
• Kim S
• Cho E
• Lee JS
• Lee H

• KMID: 2429123
• DOI: http://doi.org/10.3343/alm.2018.38.6.569

Abstract

BACKGROUND
The increasing prevalence of drug-resistant tuberculosis (TB) infection represents a global public health emergency. We evaluated the usefulness of a newly developed multiplexed, bead-based bioassay (Quantamatrix Multiplexed Assay Platform [QMAP], QuantaMatrix, Seoul, Korea) to rapidly identify the Mycobacterium tuberculosis complex (MTBC) and detect rifampicin (RIF) and isoniazid (INH) resistance-associated mutations.
METHODS
A total of 200 clinical isolates from respiratory samples were used. Phenotypic anti-TB drug susceptibility testing (DST) results were compared with those of the QMAP system, reverse blot hybridization (REBA) MTB-MDR assay, and gene sequencing analysis.
RESULTS
Compared with the phenotypic DST results, the sensitivity and specificity of the QMAP system were 96.4% (106/110; 95% confidence interval [CI] 0.9072-0.9888) and 80.0% (72/90; 95% CI 0.7052-0.8705), respectively, for RIF resistance and 75.0% (108/144; 95% CI 0.6731-0.8139) and 96.4% (54/56; 95% CI 0.8718-0.9972), respectively, for INH resistance. The agreement rates between the QMAP system and REBA MTB-MDR assay for RIF and INH resistance detection were 97.6% (121/124; 95% CI 0.9282-0.9949) and 99.1% (109/110; 95% CI 0.9453-1.0000), respectively. Comparison between the QMAP system and gene sequencing analysis showed an overall agreement of 100% for RIF resistance (110/110; 95% CI 0.9711-1.0000) and INH resistance (124/124; 95% CI 0.9743-1.0000).
CONCLUSIONS
The QMAP system may serve as a useful screening method for identifying and accurately discriminating MTBC from non-tuberculous mycobacteria, as well as determining RIF- and INH-resistant MTB strains.

Keyword

Mycobacterium tuberculosis complex; Rifampicin; Isoniazid; Drug susceptibility testing; Quantamatrix Multiplexed Assay Platform

MeSH Terms

Biological Assay
Emergencies
Isoniazid
Mass Screening
Methods
Mycobacterium tuberculosis*
Mycobacterium*
Prevalence
Public Health
Rifampin
Sensitivity and Specificity
Seoul
Tuberculosis, Multidrug-Resistant
Isoniazid
Rifampin

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