Cui Zhen-ling, Sha Wei, Huang Xiao-chen, Zheng Rui-juan, Ju Jin-liang, Hu Zhong-yi
Shanghai Key Laboratory of Tuberculosis, Tuberculosis Diagnosis Center, Shanghai Pulmonary Hospital Affiliated to Tongji University, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2011 Dec;34(12):894-7.
To evaluate the use of isothermal RNA amplification assay for detection of Mycobacterium tuberculosis (SAT-TB) in sputum samples.
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.
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).
SAT-TB is a rapid, sensitive and specific method for detection of Mycobacterium tuberculosis in clinical sputum samples.
评估等温RNA扩增法检测痰液样本中结核分枝杆菌（SAT-TB）的应用。
采用SAT-TB和罗氏（L-J）培养法对244例肺结核患者及其他肺部疾病患者的痰液样本进行检测。对SAT-TB和L-J培养结果不同的样本，采用结核分枝杆菌PCR荧光诊断试剂盒进行检测。根据L-J培养结果计算SAT-TB的灵敏度和特异度。根据临床诊断分析SAT-TB和L-J培养的检出率，采用卡方检验分析两种方法的差异。
以L-J培养结果为参照，SAT-TB的灵敏度和特异度分别为92%（71/77）和86%（143/167）。SAT-TB与L-J培养的符合率为88%（214/244）。对于肺结核患者，L-J培养和SAT-TB的检出率分别为42%（75/177）和54%（95/177）。经卡方检验，SAT-TB与L-J培养检出率的差异有统计学意义（χ² = 4.527，P < 0.05）。
SAT-TB是临床痰液样本中检测结核分枝杆菌的一种快速、灵敏且特异的方法。
