Beijing CapitalBio Technology Co., Ltd.

The WHO ranks Tuberculosis as “the second leading cause of death from a single infectious agent”. It is estimated that in 2013, there were 9 million new TB cases and 1.1 million deaths resulting from TB worldwide. To make the situation worse, the problem of multidrug resistance is increasingly severe. According to the WHO, in 2013, there were approximately 480,000 new MDR-TB cases and 210,000 deaths resulting from MDR-TB around the world. The WHO points out that “laboratory confirmation of TB and drug resistance” is critical to ensuring correct diagnosis and correct treatment for individuals with TB signs and symptoms. CapitalBio Tuberculosis and Non-Tuberculous Mycobacteria Real-Time PCR Detection Kit and CapitalBio M. tuberculosis Drug Resistance Detection Array Kit constitute useful tools for “laboratory confirmation of TB and drug resistance”. Together with CapitalBio Mycobacterial Species Identification Array Kit and Aminoglycoside-Induced Deafness Gene Mutations Detection Kit, they help to ensure correct diagnosis and correct treatment for individuals with TB signs and symptoms.

Key Features

● CapitalBio Tuberculosis and Non-Tuberculous Mycobacteria Real-Time PCR Detection Kit is designed for a rapid and accurate screening of MTB/NTM infection. It employs duplex real-time fluorescence PCR technology and detects both MTB infection and NTM infection with only one test. Its detection limit for MTB is 10 CFU/PCR and its detection limit for NTM is 100 CFU/PCR. The testing process takes only 3 hours. 1017 clinical tests demonstrate that its specificity is 99%. It is compatible with a variety of fluorescence PCR systems.

● CapitalBio M. tuberculosis Drug Resistance Detection Array Kit is designed for a rapid and accurate detection of gene mutations related to drug resistance to the two first-line anti-TB drugs, rifampicin and isoniazid. It detects 16 mutations in 3 genes with only one test. Its detection limit is 1×10³ CFU/reaction. The testing process takes only 6 hours. 1186 clinical tests demonstrate that its sensitivity for rifampicin is 92% and its specificity for rifampicin is 97.2%; its sensitivity for isoniazid is 77.4% and its specificity for isoniazid is 83.8%.

● CapitalBio Mycobacterial Species Identification Array Kit is designed for the identification of mycobacterial species which causes infection. It identifies M. tuberculosis complex and 16 NTM species with only one test. Its detection limit is 1×10³ CFU/reaction. The testing process takes only 6 hours. 1724 clinical tests demonstrate that 100% of the results obtained with CapitalBio Mycobacterial Species Identification Array Kit are consistent with the results obtained with sequencing.

● Aminoglycoside-Induced Deafness Gene Mutations Detection Kit is designed for a rapid and accurate detection of mutations related to deafness caused by the use of aminoglycosides. It helps to identify individuals likely to suffer hearing loss after using aminoglycosides and allows precautions to be taken to avoid deafness caused by inappropriate use of aminoglycosides.