Journal List > Korean J Lab Med > v.28(1) > 1011490

Kim, Park, Kim, Cho, Hwang, Kim, Lee, Jeong, Kim, and Chang: Evaluation of the Performances of AdvanSure TB/NTM Real Time PCR Kit for Detection of Mycobacteria in Respiratory Specimens

Abstract

Background

PCR is a widely used method for rapid and accurate diagnosis of mycobacteriosis. The sensitivity and specificity of a real time PCR kit newly developed in Korea were evaluated for detecting mycobacteria in respiratory specimens.

Methods

One hundred twenty nine Mycobacterium tuberculosis (TB) culture positive respiratory specimens (82 AFB stain positive and 47 stain negative specimens) were used for evaluation of the sensitivity. Nine non-tuberculous mycobacteria (NTM) culture positive specimens were also included. For evaluation of the specificity, 48 AFB stain and culture negative respiratory specimens from patients who were initially not fully excluded from mycobacterial diseases (specificity group 1) were used. Other 51 respiratory specimens from patients who were not suspected of mycobacterial diseases were also included (specificity group 2). Real time PCR was performed by using AdvanSure TB/NTM real time PCR Kit (LG Lifescience, Korea) and SLAN real time PCR detection system (LG Lifescience). The target genes of TB and NTM were IS6110 and rpoB, respectively.

Results

Among 129 TB culture positive specimens, 82 of 82 AFB stain positive specimens (100%) and 35 of 47 (74.5%) stain negative specimens revealed real time PCR positivity for TB, resulting in sensitivity of 90.7%. Five of nine NTM culture positive specimens resulted in real time PCR positivity for NTM (55.6%). Forty seven of 48 specimens (97.9%) and all 51 specimens (100%) of the specificity group 1 and 2, respectively, were real time PCR negative for TB and NTM.

Conclusions

AdvanSure TB/NTM real time PCR Kit should be useful for detecting TB in respiratory specimens with high sensitivity and specificity.

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Table 1.
Specimens used in this study
Specimens N of specimens
Mycobacteria culture positive 138
M. tuberculosis, isolated 129
  AFB stain positive 82
  AFB stain negative 47
 Nontuberculous mycobacteria, isolated 9
  AFB stain positive 3
  AFB stain negative 6
Specificity group 1 (AFB stain/culture negative) 48
Specificity group 2 (non-suspicious for mycobacterial infections) 51
Total 237

Abbreviation: AFB, acid-fast bacilli.

Table 2.
Real time PCR results of mycobacterial culture positive respiratory specimens
Culture result Total PCR positive for PCR negative (%)
TB (%) NTM
M. tuberculosis        
 AFB stain-positive 82 82 (100) 0 0 (0)
 AFB stain-negative 47 35 (74.5) 0 12 (25.5)
 Total 129 117 (90.7) 0 12 (9.3)
M. intracellulare        
 AFB stain-positive 2 0 1 1
 AFB stain-negative 1 0 0 1
M. avium        
 AFB stain-negative 2 1 0 1
NTM, unidentifiable        
 AFB stain-positive 1 0 1 0
 AFB stain-negative 3 0 3 0

False-positive for non-tuberculous mycobacteria.

Abbreviations: AFB, acid-fast bacilli; TB, M. tuberculosis; NTM, non-tuberculous mycobacteria.

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