Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice.
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.
Department of Surgery, Gwangju Veterans Hospital, Gwangju, Korea.
Won-Hyung
WH
Cho
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Eun-Jeong
EJ
Won
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Hyun-Jung
HJ
Choi
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Seung-Jung
SJ
Kee
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Jong-Hee
JH
Shin
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Dong-Wook
DW
Ryang
Department of Laboratory Medicine, Chonnam National University Medical School and Hospital, Gwangju, Korea.
Soon-Pal
SP
Suh
D004269:DNA, Bacterial / Q000235:genetics / Q000378:metabolism; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics* / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D056910:Republic of Korea; D012680:Sensitivity and Specificity; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis
D004269:DNA, Bacterial; D011933:Reagent Kits, Diagnostic
AdvanSure TB/NTM PCR; COBAS TaqMan MTB PCR; Mycobacterium tuberculosis