In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XI

2.2 Tuberculosis Diagnostic Reagents

In 2019, there were about ten million TB patients worldwide and 1.5 million deaths, and China ranks third in the world with 895,000 new cases of TB each year, most of which are pulmonary TB. The diagnosis of pulmonary TB is based on pathogen detection. Molecular diagnostic is one of the methods of pathogen detection, and the target of the test is the Mycobacterium tuberculosis complex (MTBC). Most of the molecular diagnostic reagents for tuberculosis are based on fluorescent PCR technology. In 2019, NMPA approved two Mycobacterium Tuberculosis Complex Detection Kits based on Isothermal Amplification Technologies, which are products of Guangzhou Deaou Bio-technology Co., Ltd. (“Deaou”) (Registration No.: G.X.Z.Z 20193400313) and Ustar Biotechnologies (Hangzhou) Ltd. (“Ustar”) (Registration No.: G.X.Z.Z 20193401027).

Deaou’s kit is developed based on the nucleic acid strand displacement reactions technology, and the detection target is M. tuberculosis insertion sequence IS6110. The LoD is 100 bacteria/mL. Since the copy number of the IS6110 reference strain H37Rv is 16, it can be deduced that the LoD of the kit is 1600 copies/mL, which is roughly the same as the LoD of fluorescent PCR reagents in the market. Ustar’s kit uses crossing priming amplification (CPA) technology to detect the IS6110 insertion sequence specific to the M. tuberculosis complex.

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