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 Following the outbreak of COVID-19, multiple biopharmaceutical companies within Chengdu Hi-tech Zone immediately invested in the development of testing kits, and have achieved remarkable results. On February 7th, it was announced that the new coronavirus testing kit developed by Maccura Biotechnology Co., Ltd. ("Maccura") has completed its research and development work, and has obtained good clinical test results, with the capacity to produce 200,000 tests per day

Accelerate the upgrade of the testing reagent kit and shorten the detection time to one hour. – Maccura

Since the outbreak of COVID-19, it has been crucial to have rapid tests to detect the virus. Following the publication of gene sequence data of 2019-nCoV coronavirus, major companies quickly developed diagnostic reagent kits for clinical use. These molecular diagnostic reagent kits based on nucleic acid testing of the virus have strong specificity. They can accurately, rapidly, and easily detect whether patients with symptoms such as fever and cough of unknown origin are infected with the coronavirus, identify early-stage infections, and play a critical role in the accurate diagnosis of diseases.

Maccura, as a specialized domestic enterprise in the research and production of clinical in vitro diagnostic products, started focusing on the research, production, sales, and service of in vitro diagnostic products as early as 1994. Currently, the first batch of 10,000 coronavirus pneumonia testing reagent kits produced by Maccura has been successfully trial-produced and used in clinical trials. At the same time, relevant materials have been submitted to the SFDA for a rapid approval pathway for the coronavirus reagent kits, and multiple registration processes are being synchronized for simultaneous approval.

 There are multiple characteristics of coronavirus nucleic acid testing reagent kit developed by Maccura. Quality control is implemented throughout the whole process, and the error rate is very low. In addition, the automation level of the reagent kit is high, and the extraction and detection processes are automated, which can minimize the risk of infection for medical personnel. "The detection efficiency is high, and one instrument can test 96 people in two hours," said Long Tengxiang, the R&D director of Maccura. He also claimed that the company currently has sufficient raw material supply and can produce 200,000 testing reagent kits per day, which can meet the demand in Sichuan province. Long Tengxiang also mentioned that the Maccura R&D team is currently upgrading the testing reagent kit for coronavirus, aiming to shorten the detection time from two hours for 96 samples to one hour.

Based on a "hundred-billion-level" antibody library, fast diagnostic kits and therapeutic antibodies are being developed.

On February 7th, it was reported that Chengdu Shengshi Junlian Biotech Co., Ltd. (hereinafter referred to as "ABLINK"), located in Chengdu Hi-tech Zone Tianfu Life Science Park, has formed a team of experts led by its founder, Dr. Liu Jianghai, who is a medical doctor returning from overseas. The team is using antibody library technology platform to screen antibodies against the coronavirus and is currently accelerating the development of a rapid diagnostic test kit to detect the virus, becoming one of the members of the epidemic relief army.

Liu said that since January 24th, under the guidance of experts from the Wuhan Institute of Virology of the Chinese Academy of Sciences, Liu joined forces with experts from Sichuan Kezhi Civil Defense, Chengdu Medical College, West China Second Hospital, Fudan University and University of Electronic Science and Technology to urgently develop colloidal gold rapid diagnosis test kit and therapeutic antibodies against coronavirus.

"Currently, nucleic acid testing is the ultimate diagnostic tool for coronavirus, but there is a problem with long testing cycles due to the large volume of testing," Liu said. To address this issue, ABLINK's research and development team is using immune colloidal gold chromatography technology to develop a diagnostic test kit, taking advantage of the company's existing "hundred-billion level" antibody library platform.

 It is understood that immune colloidal gold chromatography technology does not require special instruments and equipment and can achieve in vitro qualitative detection of viruses in human body fluids and serum samples quickly and sensitively. This technology has been successfully applied in various areas, including rapid detection of influenza A virus antigen, which is very suitable for the current needs of initial virus screening tests. "The application of colloidal gold detection technology depends on high-specificity and high-sensitivity antibody raw materials as the basis, but there are currently no diagnostic antibodies for coronavirus. However, we happen to have a diversity of antibodies in our antibody library at a hundred-billion level."

Liu said that the team has completed the critical material screening work for the rapid diagnostic test kit project and is conducting antigen-antibody pairing verification. "Once the material verification is completed, the development, production, and evaluation of the diagnostic test kit will be completed in the near future and will be submitted for clinical approval and use."

HCSCI Upgrades Nucleic Acid Testing Instrument, Capable of Testing over 20,000 Samples Daily

In Chengdu Tianfu International Bio-city, HC Scientific Technology Co., Ltd. ("HCSCI") has collaborated with renowned institutions such as enterprises under Guangzhou Institute of Respiratory Diseases and Fosun Diagnostics to establish a team dedicated to fighting COVID-19. Currently, the team is urgently upgrading its nucleic acid testing instrument to enable large-scale screening for COVID-19.

According to CEO Zhang Han, molecular diagnosis is a technology that diagnoses diseases by detecting changes in the structure or expression levels of genetic material in the patient's body using molecular biology methods. It is mainly used for screening and diagnosis of genetic diseases, infectious diseases, tumors, etc. Gene testing is the most critical component of molecular diagnosis and an excellent way to achieve precision medicine.

"Through testing, we can identify high-risk genes for certain diseases in the human body," Zhang said. HCSCI’s independently developed high-throughput gene genotyping system "Generatrix" can be applied to gene testing involved in agriculture, animal husbandry, human health, and scientific research areas, and has cumulatively tested over 4 million samples.

Zhang stated that upon successful development, each product can test over 20,000 samples daily, making it suitable for large-scale screening of potential COVID-19 patients in disease control centers and other units. "The prototype was installed on February 11th, and we hope to help front-line medical workers overcome this difficult period and win the battle against the epidemic."

Reprinted from ChengDu GaoXin