News from this reporter (reporter Cao Zheng) Another new coronavirus test kit developed by enterprises in the development zone has been approved for listing, and the results can be obtained within one hour at the earliest. The reporter learned yesterday that the "new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method)" developed by Beijing Najie Diagnostic Reagent Co., Ltd. (hereinafter referred to as "Najie Diagnostics"), an enterprise in the development zone, has recently obtained national medicines. Registration certificate of the supervisory bureau.
The main feature of this test kit is fast. The conventional nucleic acid testing process is that after the medical testing personnel collect human samples, they are transported to the testing laboratory for inactivation, killing viral top protein to eliminate infectivity, and then performing nucleic acid testing. The whole process has many steps and long time, and there are also certain risks.
Is there a way to reduce intermediate links? According to reports, after the outbreak of the new coronavirus pneumonia outbreak, the research and development team of Najet Diagnostics developed a storage solution and reagents for the detection of new coronavirus pneumonia. Among them, the preservation solution can be in a test tube-sized container, at the same time to achieve inactivation and nucleic acid release.
This means that after the staff collects the human pharyngeal swab, it is directly placed in the pharyngeal swab collection tube containing the preservation solution, and the inactivation and nucleic acid release can be automatically completed during transportation; Add it directly to the reagent in the safety cabinet, and then test it on the machine. The inspection work can be completed in one step, and the inspection time is shortened from the conventional 2-3 hours to more than 1 hour. Throughout the process, laboratory testing personnel do not directly contact the virus, reducing the risk of virus infection.
As the speed becomes faster, will the accuracy be low? Currently, the new detection reagents for coronavirus pneumonia are generally two-color and three-color fluorescence. The three-color fluorescence reagent developed by Najet Diagnostics can improve the detection accuracy. "Just like identifying a person with scientific and technological means, the more recognition channels such as face recognition, fingerprint recognition, iris recognition, voice recognition, etc., the more accurate the recognition." The relevant person in charge explained that the greater the amount of fluorescence of the detection reagent, the detection is turned on Multiple channels, the higher the detection accuracy. For the new product of Nage Diagnostic Virus Detection, only 15 to 20 microliters of samples need to be added to achieve high detection accuracy and reduce the rate of missed detections.
According to the development zone, in order to ensure future market supply, Najet Diagnostics previously prepared 1 million people for the production of raw materials and coordinated with the raw material suppliers. Now after obtaining the registration certificate, mass production will begin.