호흡기 검체를 이용한 AdvanSure TB/NTM Real Time PCR Kit의 항산균 진단 능력평가 = Evaluation of the Performances of AdvanSure TB/NTM Real Time PCR Kit for Detection ofMycobacteria in Respiratory Specimens

다국어 초록 (Multilingual 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. (Korean J Lab Med 2008;28:34-8)

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