TBG Diagnostics Limited (TDL), a global molecular diagnostics company, headed by Sri Lankan entrepreneur Jitto Arulampalam, announced that its subsidiary, TBG Biotechnology Corp, has received CE Mark approval for its COVID-19 Nucleic Acid and Antibody Rapid test kits.
The CE Mark approval covers TDL’s ExProbeTM SARS-CoV-2 (ExProbe test kit) Testing Kit and its SARS-CoV-2 IgG/IgM Rapid Test Kit (Rapid test kit).
The CE Mark indicates that the test kits meet the essential health, safety and environmental protection requirements to sell the kits in the European market as well as any other country that accept CE-mark.
Both tests are manufactured by TBG Biotechnology in Taiwan and will be exported from there to the destination country. Furthermore,“there is a potential that the company might set up a manufacturing facility in Sri Lanka for the export market.”
TBG says the tests take up to 15 minutes to complete and detect the presence of SARS-CoV-2 specific, IgM and IgG antibodies, in the blood, serum and plasma. This means the test can be used to confirm if a subject has been infected with the COVID-19 virus.
“IgM and IgG antibodies usually generated in the body 7-10 days after SARS-CoV-2 infection and can last for weeks. This test is often used to confirm if he/she has been infected with the COVID-19 virus. This rapid test uses droplet of blood, serum or plasma as testing sample. Together, these two test products are expected to be able to confirm symptomatic individuals with an active SARS-CoV-2 viral infection and those who have been infected by SARS-CoV-2 and generated a specific antibody response,” the company explained.
About TBG Diagnostics (TDL)
TBG Diagnostics Limited (TDL) is a global molecular diagnostics company dedicated to the development, manufacture and marketing of molecular diagnostics kits, instruments and services. With its research and development based in the US, Taiwan and China, TDL manufactures its products in its ISO13485 certified facilities in Xiamen, China serving the clinical labs of both hospitals and independent reference labs, blood centers and bone marrow registry labs around the world. The company is currently headed by Jitto Arulampalam, a Sri Lankan based in Australia.