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PloS one
2017;12 (8): e0182988.

Diagnostic utility of a line probe assay for multidrug resistant-TB in smear-negative pulmonary tuberculosis.

Binit Kumar Singh, Surendra K Sharma, Rohini Sharma, Vishnubhatla Sreenivas, Vithal P Myneedu, Mikashmi Kohli, Dinkar Bhasin, Sanjay Sarin
Author Information
  1. Binit Kumar Singh: Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
  2. Surendra K Sharma: Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India. ORCID
  3. Rohini Sharma: Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
  4. Vishnubhatla Sreenivas: Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
  5. Vithal P Myneedu: National Institute Tuberculosis and Respiratory Diseases, New Delhi, India.
  6. Mikashmi Kohli: Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
  7. Dinkar Bhasin: Department of Internal Medicine, All India Institute of Medical Sciences, New Delhi, India.
  8. Sanjay Sarin: Foundation for Innovative New Diagnostics, New Delhi, India.
PMID: 28829779 DOI: 10.1371/journal.pone.0182988

Abstract

OBJECTIVE: To evaluate the performance of Genotype MTBDRplus VER 2.0 in the diagnosis of Mycobacterium tuberculosis (MTB) in sputum smear-negative pulmonary TB cases.
METHODS: A total of 572 Ziehl-Neelsen sputum smear-negative samples were selected and subjected to line probe assay (Genotype MTBDRplus VER 2.0), and culture in mycobacterial growth indicator tube (MGIT-960). Immunochromatographic test was used to confirm the MTB-complex (MTBC) in culture-positive samples and phenotypic drug-susceptibility testing was done using MGIT-960.
RESULTS: The line probe assay was able to diagnose MTBC in 38.2% (213/558) of specimens after excluding 14 nontuberculous mycobacteria. Sensitivity and specificity of the assay were 68.4% and 89.3% respectively, considering MGIT-960 culture as gold standard after excluding contaminated and invalid results. On comparing with composite reference standard, the assay had 71.5% sensitivity and 100% specificity in the diagnosis of tuberculosis. The sensitivity and specificity for detecting resistance to rifampicin (RMP) were 100% and 99.24% respectively and for resistance to isoniazid (INH) were 97.62% and 98.55%, respectively.
CONCLUSION: Genotype MTBDRplus VER 2.0 is a rapid and precise diagnostic tool for detection of MTB in sputum smear-negative samples. It also facilitates accurate diagnosis of RMP and INH resistance within turn around-time.

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MeSH Term

Adult
Female
Humans
Male
Middle Aged
Tuberculosis, Multidrug-Resistant
Tuberculosis, Pulmonary
Young Adult
Journal Article
Article has an altmetric score of 8

Word Cloud

Created with Highcharts 10.0.0assaysmear-negativeGenotypeMTBDRplusVER20diagnosistuberculosissputumsampleslineprobeMGIT-960specificityrespectivelyresistanceMTBpulmonarycultureMTBCexcludingstandardsensitivity100%RMPINHOBJECTIVE:evaluateperformanceMycobacteriumTBcasesMETHODS:total572Ziehl-NeelsenselectedsubjectedmycobacterialgrowthindicatortubeImmunochromatographictestusedconfirmMTB-complexculture-positivephenotypicdrug-susceptibilitytestingdoneusingRESULTS:ablediagnose382%213/558specimens14nontuberculousmycobacteriaSensitivity684%893%consideringgoldcontaminatedinvalidresultscomparingcompositereference715%detectingrifampicin9924%isoniazid9762%9855%CONCLUSION:rapidprecisediagnostictooldetectionalsofacilitatesaccuratewithinturnaround-timeDiagnosticutilitymultidrugresistant-TB

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