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Diagnostic usefulness of the GenoType MTBDRplus assay for detecting drug-resistant tuberculosis using AFB smear-negative specimens with positive TB-PCR result

Authors
Lee Y.S.Kang H.-R.Lee S.-H.Kim Y.Kim M.-Y.Shin J.H.Moon J.Y.Lee H.-K.Park S.Y.Mo E.-K.Park Y.B.Moon S.-Y.Oh M.Ko Y.
Issue Date
2016
Publisher
Taylor and Francis Ltd.
Keywords
AFB smearnegative specimen; MTBDRplus; Mycobacterium tuberculosis
Citation
Infectious Diseases, v.48, no.5, pp 350 - 355
Pages
6
Indexed
SCI
SCIE
SCOPUS
Journal Title
Infectious Diseases
Volume
48
Number
5
Start Page
350
End Page
355
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/7120
DOI
10.3109/23744235.2015.1122831
ISSN
2374-4235
2374-4243
Abstract
Background The aim of this study was to evaluate the diagnostic accuracy of the GenoType MTBDRplus assay in detecting drug-resistant tuberculosis (DR-TB) by using acid-fast bacilli (AFB) smear-negative specimens with positive TB-PCR results. Methods The MTBDRplus assay was performed with 2 different categories of 117 samples, including AFB smear-positive specimens (n=53) and AFB smear-negative specimens (n=64), which exhibited positive TB-PCR results, at a single institution. The results were retrospectively compared with the results of the phenotypic drug susceptibility test (DST), for reference. Results A total of 105 tests were finally analyzed. Of these, 54 tests were conducted using AFB smear-negative specimens with positive TB-PCR results. The MTBDRplus assay for these 54 samples demonstrated a sensitivity of 100%, specificity of 98%, positive predictive value (PPV) of 75%, and negative predictive value (NPV) of 100% in detecting rifampicin resistance. With these same species, the sensitivity, specificity, PPV, and NPV values for the MTBDRplus assay were 83.3%, 97.9%, 83.3%, and 97.9%, respectively, for the detection of isoniazid resistance. The overall correlation between the MTBDRplus assay and phenotypic DST demonstrated excellent agreement for detection of rifampicin resistance (κ=0.847) and for detection of INH resistance (k=0.812), respectively. Conclusions The MTBDRplus assay can be used effectively even on AFB smear-negative specimens from TB patients, when the TB-PCR is positive. This result might help clinicians to manage patients with suspected DR-TB in difficult situations. © 2015 Society for Scandinavian Journal of Infectious Diseases.
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Lee, Young Seok
Guro Hospital (Department of Pulmonary, Allergy, and Critical Care Medicine, Guro Hospital)
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