title: [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.
authors.affiliation: Department of Laboratory Medicine, School of Medicine, Pusan National University, Busan, Korea.
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Mi Young
authors.initials: MY
authors.lastname: Park
authors.forename: Shine Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Son A
authors.initials: SA
authors.lastname: Cho
authors.forename: Sang Hyun
authors.initials: SH
authors.lastname: Hwang
authors.forename: Hyung Hoi
authors.initials: HH
authors.lastname: Kim
authors.forename: Eun Yup
authors.initials: EY
authors.lastname: Lee
authors.forename: Joseph
authors.initials: J
authors.lastname: Jeong
authors.forename: Kyeong Hee
authors.initials: KH
authors.lastname: Kim
authors.forename: Chulhun L
authors.initials: CL
authors.lastname: Chang
mesh_terms: 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*
chemical_list: D004269:DNA, Bacterial; D011933:Reagent Kits, Diagnostic