On March 1st, the “COVID-19 2019-nCoV Nucleic Acid Detection and Diagnosis Kit by Fluorescent PCR Method” was approved by the National Medical Products Administration and received the medical registration license. The kit was developed by the research team led by Prof. Yang Zhenglin, Dean of the School of Medicine of UESTC and Vice President of Sichuan Provincial People's Hospital, together with Maccura Biology Co., Ltd. Meanwhile, on March 5th, this kit and the SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method was granted approval by the EU, and would serve as an effective testing tool for global epidemic prevention and control.
SARS-CoV-2 IgM/IgG Antibody Assay Kit (Colloidal Gold Method)
After the outbreak of the COVID-19 epidemic, Prof. Yang Zhenglin's team initiated research on the “COVID-19 Rapid Diagnosis and Treatment Technology”. Together with Maccura Biology Co., Ltd, the team carried out scientific researches in defiance of difficulties. Despite trials and tests they finally succeeded in developing an accurate and rapid detection kit for COVID-19. Results of the research project included four kits: a COVID-19 Nucleic Acid Detection Kit, a SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method and a COVID-19 Specific IgM Kit as well as an IgG Antibody Detection Chemiluminescence kit. The COVID-19 Nucleic Acid Detection Kit by Multiple Fluorescent RT-PCR Method was approved this time.
SARS-Cov-2（Gene ORF1ab/E/N）Nucleic Acid Detection Kit (Fluorescent RT-PCR Method)
COVID-19's diagnosis was based on the nucleic acid test positive in nasopharyngeal swabs, sputum, bronchoalveolar lavage fluid or feces of patients with its infection. The Multiple Fluorescent RT-PCR Kit developed by Prof. Yang Zhenglin’s team and Maccura Biology Co., Ltd. mainly targeted at virus ORF1a, N and E with false virus as positive control. At present, the kit was on mass production and used in the frontline of anti-epidemic work in many medical institutions in Whuhan, Chengdu and many other cities in China.
In addition, in line with the principle that the human immune system could produce specific antibodies after COVID's infection, Prof. Yang Zhenglin's team and Maccura Biology Co., Ltd. developed the colloidal gold and chemiluminescence methods by constructing plasmids to present COVID-19 N-protein and S-protein as antigens. As a result, the virus-specific IgM and IgG antibodies in human serum could be detected quickly and accurately. These three antibody detection kits would effectively reduce the technical difficulty of COVID-19 laboratory detection and greatly improve the detection efficiency, so that they were especially suitable for mass sample screening. Currently, application for the in vitro diagnostic registration of the three kits is in process.
Translated by Xie Wenjuan, supervised by Long Mei.