Recently, reporters learned from Hangzhou Medical College that the key project of SARS-COV-2 detection organized by the Department of Science and Technology of Zhejiang Province has been developed and completed. The SARS-COV-2 Nucleic Acid Diagnostic Kit takes 29 minutes as fast, and the SARS-COV-2 IgM/IgG Antibody Detection Reagent (colloidal gold method) only takes 2 minutes to complete the detection.
It is reported that the joint research team is composed by Hangzhou Medical College, Zhejiang Oriental gene biological products Co., Ltd. and Zhejiang Provincial Center for Disease Control and prevention, led by Professor Lv Jianxin of Hangzhou Medical College as the chief scientist.
According to Lv Jianxin, the project aims at solving the problem of rapid diagnosis and accurate diagnosis of SARS-COV-2. The so-called fast is to reduce the time required for traditional fluorescent PCR to detect viral RNA from 3 hours to about 30 minutes. The so-called accuracy is to improve the specificity and sensitivity of detection, and reduce false positive and false negative.
Developing from three levels of rapid detection of viral nucleic acid,antibody and antigen, SARS-COV-2 IgM/IgG antibody detection reagent (colloidal gold method) was developed for the detection of SARS-COV-2. The product has been verified in more than 500 clinical samples in many medical institutions. IgM / IgG dual indicator rapid diagnostic colloidal gold reagent are able to complete the test in 2 minutes at minimum.
It is easy to operate and no instrument is needed. Only 10μl of fingertip whole blood is needed to drip into the test hole, and the samples infected for 3-7 days can be detected, with an accuracy rate reaching more than 97%, which therefore greatly reduces the risk of infection during the test. A positive result of antibody test indicates that the patient is currently infected or has a previous infection. It can be used in the current monitoring of enterprises resumption, school opening and other resumption, as well as self-test at home.
LV Jianxin said that at the same time, an one-step fluorescent PCR kit without nucleic acid extraction is developed by the project team for the detection of SARS-COV-2. Its clinical trials have been completed and we are applying for the registration certificate of medical devices. The product integrates the sample lysate with the amplification system, and the clinical specimen washing liquid or specimen preservation solution such as throat swabs and sputum can be directly extracted from the nucleic acid system, which can directly enter the PCR system and realize closed tube expansion. The detection was completed in 29 minutes as soon as possible with a sensitivity of less than 300 copies / ml. Compared with the existing real-time fluorescent PCR reagent, the coincidence rate is more than 97%, and the specificity is higher than 99%.
"We hope to improve the diagnosis efficiency of SARS-COV-2 through joint diagnosis." Lv Jianxin said that important progress has been made in the virus antigen detection reagents being developed by the project team, and the follow-up triple inspection is expected to further shorten the detection time and improve the specificity and sensitivity.
At present, Zhejiang Dongfang Gene Biological Products Co., Ltd., a member of the project team, has achieved mass production of SARS-COV-2 nucleic acid detection kit (extraction-free fluorescence PCR method) and SARS-COV-2 colloidal gold detection reagent. The product was first registered in the European Union for the record. Recently, we have received orders from Britain, France, Switzerland, Austria, Georgia, India, Japan, the United States and other countries and regions. The research and development team of the project team is intensifying clinical trials and registration declarations of statutory testing institutions, and actively organizing various production materials, production lines, and mass production of SARS-COV-2 IgM / IgG antibody detection reagents (colloidal gold method) and nucleic acid diagnostic reagents, so as to fight against SARS-COV-2.