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

Young Seok Lee, Hye Rim Kang, Si Hyeong Lee, Yunmi Kim, Mi Yeong Kim, Jeong Hwan Shin, Jae Young Moon, Hyun Kyung Lee, So Young Park, Eun Kyung Mo, Yong Bum Park, Soo Yoon Moon, Minkyung Oh, Yousang Ko

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish
Pages (from-to)350-355
Number of pages6
JournalInfectious Diseases
Volume48
Issue number5
DOIs
StatePublished - 2016

Bibliographical note

Publisher Copyright:
© 2015 Society for Scandinavian Journal of Infectious Diseases.

Keywords

  • AFB smearnegative specimen
  • MTBDRplus
  • Mycobacterium tuberculosis

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