[Evaluation of the performances of AdvanSure TB/NTM real time PCR kit for detection of mycobacteria in respiratory specimens].
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.
Kim
Young Jin
YJ
Department of Laboratory Medicine, School of Medicine, Pusan National University, Busan, Korea.
Park
Mi Young
MY
Kim
Shine Young
SY
Cho
Son A
SA
Hwang
Sang Hyun
SH
Kim
Hyung Hoi
HH
Lee
Eun Yup
EY
Jeong
Joseph
J
Kim
Kyeong Hee
KH
Chang
Chulhun L
CL
D004269:DNA, Bacterial / Q000032:analysis; D006801:Humans; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D012137:Respiratory System / Q000382:microbiology; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D014376:Tuberculosis / Q000175:diagnosis*
D004269:DNA, Bacterial; D011933:Reagent Kits, Diagnostic