title: [Evaluation of the isothermal RNA amplification assay for Mycobacterium tuberculosis in sputum samples].
abstract: OBJECTIVE
  To evaluate the use of isothermal RNA amplification assay for detection of Mycobacterium tuberculosis (SAT-TB) in sputum samples.
  
  
  METHODS
  A total of 244 sputum samples from patients with pulmonary tuberculosis and those with other lung diseases were detected by SAT-TB and Lowenstein-Jensen (L-J) culture. The samples with different results between SAT-TB and L-J culture were tested by Mycobacterium tuberculosis PCR fluorescence diagnostic kits. The sensitivity and specificity of SAT-TB were calculated according to the results of L-J culture. The detection rates of SAT-TB and L-J culture were analyzed according to the clinical diagnosis and the difference of the 2 methods were analyzed by chi-square test.
  
  
  RESULTS
  With the result of L-J culture as the reference, the sensitivity and the specificity of SAT-TB were 92% (71/77) and 86% (143/167), respectively. The accordance rate of SAT-TB and L-J culture was 88% (214/244). For tuberculosis patients, the detection rate of L-J culture and SAT-TB was 42% (75/177) and 54% (95/177) respectively. The difference between the detection rates of SAT-TB and L-J was significant by chi-square test (χ² = 4.527, P < 0.05).
  
  
  CONCLUSIONS
  SAT-TB is a rapid, sensitive and specific method for detection of Mycobacterium tuberculosis in clinical sputum samples.
authors.affiliation: Shanghai Key Laboratory of Tuberculosis, Tuberculosis Diagnosis Center, Shanghai Pulmonary Hospital Affiliated to Tongji University, China.
authors.forename: Zhen-ling
authors.initials: ZL
authors.lastname: Cui
authors.forename: Wei
authors.initials: W
authors.lastname: Sha
authors.forename: Xiao-chen
authors.initials: XC
authors.lastname: Huang
authors.forename: Rui-juan
authors.initials: RJ
authors.lastname: Zheng
authors.forename: Jin-liang
authors.initials: JL
authors.lastname: Ju
authors.forename: Zhong-yi
authors.initials: ZY
authors.lastname: Hu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012329:RNA, Bacterial; D012680:Sensitivity and Specificity; D013183:Sputum / Q000382:microbiology*; D014397:Tuberculosis, Pulmonary / Q000382:microbiology; D055815:Young Adult
chemical_list: D012329:RNA, Bacterial