Analytical and Clinical Performance of Abbott RealTime MTB, an Assay for Detection of Mycobacterium Tuberculosis in Pulmonary Specimens

Tuberculosis (Edinb). 2015 Sep;95(5):613-9. doi: 10.1016/j.tube.2015.05.010. Epub 2015 May 27.

Abstract

Nucleic acid amplification test (NAAT)-based assays provide fast and sensitive results compared to conventional TB tests. The performance of the new Abbott Molecular MTB assay for the qualitative detection of MTB complex using the automated m2000™ system or manual sample preparation is summarized in this paper. The assay detects eight MTB complex subspecies. The observed limit of detection (LOD) when used to test an MTB H37Rv panel was 2.45 colony forming units (cfu)/mL, while the claimed assay LOD with this MTB strain is 17 cfu/mL. No cross reactivity, or carryover were observed in the study. The clinical sensitivity of the assay was 93% overall; 99% in smear positive, culture positive specimens, and 81% in smear negative, culture positive samples. The clinical specificity was 97%. The inhibition rate in the study was 0.34%. The data suggest that Abbott RealTime MTB is a reliable, robust and sensitive assay for the molecular detection of MTB.

Keywords: Co-infection; Inactivation; Mycobacterium; Reproducibility; Respiratory; Sensitivity; Specificity.

Publication types

  • Evaluation Study

MeSH terms

  • Bacteriological Techniques*
  • Colony Count, Microbial
  • DNA, Bacterial / genetics*
  • High-Throughput Nucleotide Sequencing*
  • Humans
  • Limit of Detection
  • Mycobacterium tuberculosis / classification
  • Mycobacterium tuberculosis / genetics*
  • Mycobacterium tuberculosis / isolation & purification
  • Nucleic Acid Amplification Techniques*
  • Predictive Value of Tests
  • Reproducibility of Results
  • Sputum / microbiology
  • Tuberculosis, Pulmonary / diagnosis*
  • Tuberculosis, Pulmonary / microbiology

Substances

  • DNA, Bacterial