Taiwan CDC authorizes ETERNAL COVID-19 IgM/IgG antibody rapid test kits
No special equipment needed, quick sampling by fingertip blood, results in 15 minutes with accuracy of 98%
Eternal Materials (1717 TT) announced on 3 August as the first domestic company to receive authorization from Taiwan Center for Disease Control (CDC) to manufacture COVID-19IgM/IgG rapid test kits. So far, the test kit had been validated and approved by CE and TFDA and is applying for the certificate of FDA EUA. As for the next stage, the company plans to increase their manufacturing production capacity.
Founded in 1964, Eternal Materials is the world’s leading supplier of dry film photoresist and the largest supplier of synthetic resins in Asia. The company has 23 production sites worldwide, 570+ R&D manpower and almost 5,000 employees globally. In 2013, Eternal Materials entered biomedical field and focused on in-vitro diagnostic (IVDs), molecular diagnostics and infectious disease surveillance. Since then, the company has constantly worked with various academic research institutes and government units to accelerate learning curves. Through the accumulation of practical experiences, today, Eternal Materials has developed membrane and enzyme reagents applied for the blood glucose industry and in-vitro diagnostic tools, such as Dengue NS1 Serotyping Antigen Rapid Test Strips and ETERNAL COVID-19 IgG/IgM Rapid Test Kit.
After the outbreak of COVID-19 epidemic, Taiwan CDC had contacted couples of biomedical companies, including Eternal Materials, to co-develop COVID-19 rapid test kits in order to contain the pandemic.
When humans are first infected with new bacteria or virus, our bodies make Immunoglobulin M (IgM) antibody. And Immunoglobulin G (IgG) antibody typically appears in the blood in the weeks of onset of infection. With accumulated experiences and technology, ETERNAL COVID-19 IgG/IgM Rapid Test Kit is a one-step in-vitro diagnostic test based on the combination of nucleic acid detection and antibodies detection (IgG and IgM). The method is designed to detect whether there is an immunoglobulin caused by coronavirus in human bodies. According to Eternal Materials, just by sampling fingertip blood, within 15 minutes, they can distinguish whether the subject is in his/her initial stage of infection (IgM antibody) or middle or late stages of infection (IgG antibody). The operation is simple, no special equipment needed.
From the perspective of epidemic prevention, nucleic acid detection and antibody detection (IgG and IgM) were combined to improve the testing accuracy of patients with suspected COVID-19 infection. This detection method can effectively screen both confirmed cases and asymptomatic infections. With the CDC’s use authorization, the test kit is immediately available for suspicious patients with symptoms, mild symptoms, or even without symptoms. It is also a convenient and affordable testing option for someone under quarantine control or the one with close contact of infected patients. The result demonstrates accuracy of 98%, specificity of 99% and sensitivity of 93%, the data said.
As a new wave of the novel coronavirus and measures to loosen border control, the demand for COVID-19 detection is therefore ever-increasing globally.