Accuracy of Commercial Molecular Diagnostics for the Detection of Pulmonary Tuberculosis in China: A Systematic Review

Abstract

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

The Lancet Commission on diagnostics: transforming access to diagnostics

“…For example, in 2020, an Indian molecular test for tuberculosis was endorsed by WHO, 229 while China has several indigenous tuberculosis molecular diagnostics. 230 These products are already being scaled up in India and China. In diagnostic imaging, an Indian artificial intelligence tool for CT scans of the head was approved by the US Food and Drug Administration.…”

Retrospective analysis of patients with non-tuberculous mycobacteria from a primary hospital in Southeast China

“…The molecular identification including genes (rpoB, hsp65, 16S rRNA and ITS region) sequencing rely on a large number of the strains, and should be performed based on a positive culture [22][23][24] . LPA and GeneXpert assays (detecting MTB/RIF) could differentiate MTB and NTM with considerable specificity and sensitivity in a broad range of sample sources, but it has not been applied commonly in primary hospitals because of requiring special equipment 25 . Thus, the acid-fast staining assay of samples before culture and immunological assays such as IFN-gamma release assay and T-spot assay would provide timely information for the diagnosis of active or latent tuberculosis 26,27 .…”

Advances in Molecular Diagnosis of Tuberculosis

“…However, none of these technologies have been reviewed by WHO, and therefore, uptake by other countries is limited. Table 2 summarizes the performance of some of these assays from systematic reviews ( 38 , 39 ).…”

“…CFDA-approved since 2014, EasyNAT (Ustar Biotechnologies, Hangzhou, China) replicates and detects mycobacterial DNA from sputum via cross-priming amplification (CPA). As CPA is an isothermal technique, EasyNAT may be placed at low levels of health care systems, as a thermal cycler is not required ( 38 ). A fully integrated and automated next-generation version is in development ( 40 ).…”