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中国肺结核检测中商业化分子诊断的准确性

This systematic review assesses the accuracy of molecular diagnostic methods for the detection of pulmonary tuberculosis in studies performed in China, published in Chinese and English.

We searched for studies that assessed the accuracy of molecular diagnostics for pulmonary TB in China in the China National Knowledge Infrastructure, the Wanfang Database, SinoMed, VIP Information, Pubmed,Embase, and the Cochrane Library.

For each index test, a summary estimation for sensitivity and specificity was calculated using the bivariate random一effects model. A total of 59 studies were included in oUr analysis. Loop一mediated isothermal amplifcation (LAMP) assay (six studies; pooled sensitivity 90%, 95% CI 78一95%; specificity 93%, 85一97%), line probe assay (LPA) (one study; 87%, 84一90%; 94%, 92一95%) and polymerase chain reaction (PCR) (FQ一PCR and RT一PCR) (four studies; 90%, 55一99%; 93%, 71一99%) showed good diagnostic performance in the meta一analysis. The highest pooled sensitivity was from Xpert MTB/RIF (20 studies; pooled sensitivity 91%, 95% CI 87一94%). The highest pooled specifcity was from cross一priming amplifcation (CPA) (six studies; pooled specificity 97%, 95一99%). The lowest pooled sensitivity and specificity were from simultaneous amplification and testing (SAT)一TB (three studies; 79%, 66一88%; 72%, 48一88%). In subgroup analysis, molecular diagnostics demonstrated higher sensitivity for pulmonary TB detection in smear一positive specimens. Xpert MTB/RIF, LAMP, LPA, CPA and PCR demonstrated high accuracy overall for pulmonary tuberculosis detection, while SAT一TB had poor performance.