Medical equipment registration certificate for the constant temperature amplification nucleic acid analyzer

The nucleic acid analyzer developed by Capitalbio, a Tsinghua Holdings’ member enterprise, obtained national medical equipment registration certificate, which marks a new age in which accurate diagnosis of infectious disease is a reality in China.

The high-flux constant temperature amplification nucleic acid analyzer, developed through technological innovation, changed the situation in which pharmaceutical treatment of respiratory infection based on doctors’ experience is common practice.

The analyzer, by combining a micro fluidic chip and isothermal amplification technology as well as the consumables developed by Capitalbio such as a chip kit, can provide totally accurate medical analyses.

Previously, a single test could output only one test index, and the clinical pathogen detection process was complex and time-consuming.

High-flux constant temperature amplification nucleic acid analyzer

Now the condition is totally changed. Fast, efficient and low sample reagent consumption leads to multi-index testing from one sample.

The analyzer can also realize testing of multiple samples in the same time frame which can meet clinical demand for extensive disease diagnosis in large and medium-sized hospitals.

As a platform technology for accurate medical nucleic acid analysis, it can hold many micro fluidic chip kits including a detection kit for testing respiratory pathogen nucleic acid and it can test multiple respiratory pathogenic microorganisms at the same time, which can reduce test report production time to within two hours. Treatment time for patients can thus be reduced as well.

The components of the high-flux constant temperature amplification nucleic acid analyzer can be stacked up, and can share one computer while working independently. 

In addition to respiratory pathogens, the analyzer can also be used for the rapid detection of respiratory viruses, fungi, diarrhea pathogens, bacterial drug resistance and other infectious diseases, and applied to the detection of pathogenic bacteria in the digestive tract, wound infection pathogens and other clinical testing fields.

It has many applications, such as detection of pathogens related to animal diseases or aquatic products, detection of pathogenic microorganisms in food, and detection of genetically modified agricultural products.

As the developer of thermostatic expansion nucleic acid analyzer products as early as 2015 and 2016, Capitalbio has taken the lead in research and develop of bench thermostatic amplification micro fluidic chip nucleic acid analyzers, and respiratory pathogen nucleic acid detection kits, and produced the first of their kinds in China. Both products have obtained Class Three medical equipment certification.

At present, the constant temperature amplification micro fluidic chip nucleic acid analysis system has been used in more than 300 hospitals in 31 provinces and cities in China and in tests of over 300,000 people. With the application of the high-through put constant temperature amplification nucleic acid analyzer, it’s expected that annual testing will be conducted millions of times.