关键词: 核酸扩增技术, 结核分枝杆菌, 结核性脑膜炎, 评价研究

Abstract:

Objective To investigate the clinical role of simultaneous amplification and testing（SAT） in the diagnosis of tubercular meningitis（TBM）. Methods A total of 496 suspected patients diagnosed central nervous system infection were enrolled. Among them,328 patients who were clinically diagnosed as TBM were enrolled as TBM group,while the remaining 168 patients who were clinically excluded were enrolled as control group. The cerebrospinal fluid specimens were collected and analyzed by L-J culture method,nucleic acid polymerase chain reaction（PCR） and SAT. The efficiencies of the 3 methods in detecting Mycobacterium tuberculosis（MTB） were compared. Results Taking the clinical diagnosis of TBM as gold standards,the sensitivity and specificity of SAT in detecting MTB were 15.24% and 99.40%,respectively,the sensitivity of SAT was higher than those of L-J culture method（11.28%）（χ²=2.24,P>0.05） and PCR（6.71%）（χ²=12.23,P<0.05）. The specificity of SAT was lower than those of L-J culture method and PCR（100%）（χ²=1.00,P>0.05）. Taking L-J culture method as gold standards,in TBM group,the sensitivity,specificity and consistency rate of SAT were 37.84%,87.63% and 82.01%,respectively. The sensitivity of SAT was higher than that of PCR（21.62%）,while the specificity and consistency rate were lower than those of PCR（95.19% and 86.89%）. The MTB positive detection rate of L-J culture method had no statistical significance with that of SAT（χ²=2.24,P>0.05）,but had statistical significance with that of PCR（χ²=4.19,P<0.05）. Conclusions SAT can rapidly detect MTB in cerebrospinal fluid,its sensitivity is higher than those of L-J culture method and PCR and it can provide a reference for the early diagnosis of TBM. The combined detection of the 3 methods can improve the positive detection rate of MTB in cerebrospinal fluid specimens.

Key words: Nucleic acid amplification technique, Mycobacterium tuberculosis, Tubercular meningitis, Efficiency evaluation