Utility of MPT 64 antigen detection assay for rapid characterization of mycobateria in a resource constrained setting.
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Date
2012-04
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Abstract
Introduction: Important reasons for the negligible numbers of laboratories performing characterization of Mycobacteria
in resource constrained settings are requirement of biosafety measures, longer turnaround time and laborious nature of
tests. A rapid, accurate and simple test for characterization is required. “SD BIOLINE TB Ag MPT 64 Rapid®” is a rapid
immunochromatographic test for differentiation of Mycobacteria into M. tuberculosis Complex (MTBC) and nontuberculous
mycobacteria (NTM).
Aim: To evaluate a commercial assay, SD TB Ag MPT64 Rapid® for characterization of Mycobacteria isolated on
Lowenstein Jensen (LJ) medium.
Material and methods: 150 non duplicate isolates which were previously characterized as MTBC or NTM based on
standard phenotypic characteristics were tested by the commercial assay after blinding. The result of the conventional
phenotypic test and the commercial assay was compared. Any discordant result was referred for confirmation by genotypic
Mycobacterium CM assay (Hain’s life sciences, Germany). Sensitivity and specificity of the commercial assay was
calculated using the results of conventional phenotypic and genotypic tests as gold standard.
Results: Phenotypically, 124 isolates were characterized as MTBC and 26 as NTM. The commercial assay gave concordant
results for 149 isolates. One MTBC isolate did not demonstrate a band. The sensitivity, specificity, PPV and NPV was
99.19%, 100 %, 100% and 97.3% respectively. The total turnaround time for the rapid assay was 30 minutes compared
to a few hours to days for phenotypic and genotypic method.
Conclusion: “SD BIOLINE TB Ag MPT 64 Rapid®” is a simple, rapid and reliable test to differentiate MTBC
from NTM.
Description
Keywords
Mycobacterium tuberculosis, MPT 64, Mycobacterial characterization
Citation
Kanade Swapna, Nataraj Gita, Suryawanshi Rupali, Mehta Preeti. Utility of MPT 64 antigen detection assay for rapid characterization of mycobateria in a resource constrained setting. Indian Journal of Tuberculosis. 2012 Apr; 59(2): 92-96.