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CapitalBio’s respiratory virus detection products approved for clinical application



CapitalBio Respiratory Virus Nucleic Acid Detection Kit

A respiratory virus nucleic acid detection kit (isothermal amplification method) that can detect six types of respiratory viruses including the novel coronavirus (2019-nCoV) at one time within 1.5 hours was approved by China’s National Medical Products Administration on Feb 22 to be used clinically as a novel coronavirus emergency medical device.

The detection kit was designed and developed by Tsinghua Holdings’ subsidiary CapitalBio Corporation, Tsinghua University, and West China Hospital of Sichuan University. It has been quickly applied to the frontline of novel coronavirus pneumonia (NCP) prevention and control for fast, accurate and effective diagnosis.

At a routine press conference of novel coronavirus pneumonia, also named by WHO as COVID-19, on February 18, Zhong Nanshan, a respiratory expert and head of the health commission team investigating the outbreak, pointed out the importance of separating healthy people from novel coronavirus patients, and COVID-19 patients from flu patients.

Medical workers urgently need chip technology to quickly distinguish between the novel coronavirus and influenza virus.

However, the novel coronavirus nucleic acid detection products previously approved for clinical use can only identify novel coronavirus and distinguish between healthy people and those infected with the novel coronavirus. Other tests are needed to further differentiate between COVID-19 patients and flu patients.

CapitalBio’s respiratory virus nucleic acid detection kit and its isothermal nucleic acid amplification microfluidic chip analyzer can solve all the problems simultaneously, which will improve diagnosis efficiency and increase patients’ time for treatment.


CapitalBio RTisochip Isothermal Nucleic Acid Amplification Microfluidic Chip Analyzer


CapitalBio RTisochip-W High-throughput Isothermal Nucleic Acid Amplification Microfluidic Chip Analyzer

In addition to respiratory viruses, respiratory pathogens are also regarded as an important cause of respiratory infections. With the patented isothermal amplification microfluidic technology, CapitalBio has independently developed a rapid nucleic acid detection system for respiratory pathogens. It allows for high-throughput tests for multiple samples simultaneously and can meet the current clinical need for large-scale detection of respiratory infections.

So far, the system has been put into use in more than 360 hospitals in over 30 provinces, municipalities, cities and autonomous regions across the country. It has provided rapid and accurate diagnosis for more than 500,000 patients, and has greatly overcome the limitations of existing complicated and time-consuming clinical pathogen detection methods.

When SARS broke out in 2003, CapitalBio successfully developed China's first gene chip specifically for SARS virus detection in just seven days. It played a key role in the prevention and control of the SARS epidemic in Beijing.