Evaluation of the Performance of the BD MAX MDR-TB Test in the diagnosis of <i>Mycobacterium tuberculosis</i> complex in Extrapulmonary and Pulmonary Samples.


Sağiroğlu P. , Atalay M. A.

Expert review of molecular diagnostics, 2021 (Journal Indexed in SCI) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume:
  • Publication Date: 2021
  • Doi Number: 10.1080/14737159.2021.1997594
  • Title of Journal : Expert review of molecular diagnostics
  • Keywords: BD Max, Extrapulmonary, TB, Pulmonary, Molecular diagnosis, PCR, rifampin, isoniazid, drug resistance, ASSAY

Abstract

Background The BD MAX MDR-TB is a recently marketed molecular test for detecting Mycobacterium tuberculosis complex (MTC), rifampin, and isoniazid drug resistance. Research Design and Methods This study aimed to evaluate the BD MAX MDR-TB test performance in 933 extrapulmonary and 774 pulmonary samples. Results Test MTC detecting sensitivity was 90.6%, 82.5%, and the specificity was 98.5%, 98.9%, in pulmonary and extrapulmonary samples, respectively. In smear-positive samples, sensitivity, and specificity were 100% for all samples. However, in smear-negative samples, the test's sensitivity and specificity were 82.3%, 98.5% in pulmonary samples, and 76.7%, 98.9% in extrapulmonary samples. Test sensitivity in detecting isoniazid resistance was 71.4%, specificity 96.8%, and in detecting rifampin resistance was 100%, specificity 93.9%, respectively. Conclusions BD MAX MDR-TB is a reliable, rapid, user-friendly test for detecting MTC in extrapulmonary and pulmonary samples and its resistance toward isoniazid and rifampin. It can be used as an alternative to the Xpert system assays.