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2021-08-11

TCMCTCMC as General Agency of AllBio Coronavirus Antibody Rapid Test Reagent, Certified by Taiwan FDA and EU

TUL Corporation's subsidiary Technology Created Medicine Corporation (TCMC) and its technical partner AllBio Life (hereinafter referred to as AllBio) have recently announced the launch of the "AllBio Coronavirus Antibody Rapid Test Reagent". This reagent has recently been approved by Taiwan Food and Drug Administration through clinical testing and evaluation verification for manufacturing and authenticated by EU CE, becoming one of the national team members of rapid antibody screening reagents for in vitro diagnostic (IVD). TCMC will be the sole agency to undertake the first-line epidemic prevention task.

According to TCMC, AllBio has been focusing on the research and development of immunology-related technologies and services for many years, providing professional antibody manufacturers in Taiwan with services such as gene synthesis, protein expression and customized antibodies in the academic circle and industry. AllBio Laboratory has passed international standards test TAF (ISO17025) and P2 plus laboratory certification, confirming its independent research and development, production and sample verification capabilities.

 

TCMC and AllBio initially cooperated closely in the field of intestinal bacteria detection services. With personalized intestinal bacteria detection and customized probiotics subscription model, they provide one-stop services for genetic testing, data storage, and AI algorithm analysis. After the global outbreak of Coronavirus, the demand for testing has surged. Based on years of experience and technology in developing antibodies, AllBio has successfully developed the "AllBio Coronavirus Antibody Rapid Test Reagent". TCMC and AllBio will continue to join hands to fight the epidemic.

TCMC stated that antibodies are produced in the human body after being infected with the virus. The antibody test can therefore provide information on whether the subject has been infected. In order to improve the practicability and versatility, the detection reagents developed by AllBio use two different antibodies, IgG and IgM, and adopt a dual cassette detection design to avoid signal interference and thus improve sensitivity.

IgM antibodies will be rapidly produced in the human body within 7 days after being infected with the virus. Testing positive for IgM antibodies represents an ongoing or recent infection. IgG is produced 14 days after infection and stays in the body for a longer period of time. The detection of IgG antibody is used as the basis for infection. If there is a re-infection, it is also a key test indicator to understand the number of infected people, contributing to national epidemic prevention.

The "AllBio Coronavirus Antibody Rapid Test Reagent" uses patented nano-sized gold colloidal particles as the color coating. The result can be delivered after 5 to 8 minutes with only a small amount of blood sample. There is no need to enter a dedicated testing laboratory, and the results are easy to interpret. It is suitable for airports, hospitals, communities and other first-line sites that require rapid and large-scale screening, so as to align with government PCR testing and epidemic prevention measures to build a more complete and safe protection network.

Focusing on the global development trend of digital health, TUL Corporation's subsidiary Technology Created Medicine Corporation (TCMC) actively deploy a cross-domain cooperation ecological chain of technology and healthcare. We are focusing on one stop service for genetic analysis, big data storage and AI applicaton to healthcare.

Contact Us:

TUL Corp.

周忠信 Charles Chou

Tel: +886-2-86983000ext232

Fax: +886-2-86983456

Email: charles_chou@tul.com.tw