Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice.
10.3343/alm.2015.35.3.356
- Author:
Won Hyung CHO
1
;
Eun Jeong WON
;
Hyun Jung CHOI
;
Seung Jung KEE
;
Jong Hee SHIN
;
Dong Wook RYANG
;
Soon Pal SUH
Author Information
1. Department of Surgery, Gwangju Veterans Hospital, Gwangju, Korea.
- Publication Type:Brief Communication ; Comparative Study ; Research Support, Non-U.S. Gov't
- Keywords:
AdvanSure TB/NTM PCR;
COBAS TaqMan MTB PCR;
Mycobacterium tuberculosis
- MeSH:
DNA, Bacterial/genetics/metabolism;
Humans;
Mycobacterium tuberculosis/*genetics/isolation & purification;
Reagent Kits, Diagnostic;
Real-Time Polymerase Chain Reaction;
Republic of Korea;
Sensitivity and Specificity;
Tuberculosis, Pulmonary/diagnosis
- From:Annals of Laboratory Medicine
2015;35(3):356-361
- CountryRepublic of Korea
- Language:English
-
Abstract:
The AdvanSure tuberculosis/non-tuberculous mycobacterium (TB/NTM) PCR (LG Life Science, Korea) and COBAS TaqMan Mycobacterium tuberculosis (MTB) PCR (Roche Diagnostics, USA) are commonly used in clinical microbiology laboratories. We aimed to evaluate these two commercial real-time PCR assays for detection of MTB in a large set of clinical samples over a two-year period. AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR were performed on 9,119 (75.2%) and 3,010 (24.8%) of 12,129 (9,728 respiratory and 2,401 non-respiratory) MTB specimens, with 361 (4.0%) and 102 (3.4%) acid-fast bacilli (AFB)-positive results, respectively. In MTB culture, 788 (6.5%) MTB and 514 (4.2%) NTM were identified. The total sensitivity and specificity of the AdvanSure assay were 67.8% (95% confidence interval [CI], 63.9-71.6) and 98.3% (95% CI, 98.0-98.6), while those of the COBAS TaqMan assay were 67.2% (95% CI, 60.0-73.8) and 98.4% (95% CI, 97.9-98.9), respectively. The sensitivities and specificities of the AdvanSure and COBAS TaqMan assays for AFB-positive and AFB-negative samples were comparable. Furthermore, the AdvanSure assay showed fewer invalid results compared with the COBAS TaqMan assay (5.0 vs. 20.4 invalid results/1,000 tests, P<0.001). AdvanSure assay represents a comparable yet more reliable method than COBAS TaqMan for the identification of mycobacteria in routine clinical microbiology.