- TBG Diagnostics (TDL) has announced its subsidiary, TBG Biotechnology, has received CE Mark approval for its COVID-19 Nucleic Acid and Antibody Rapid test kits
- 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
- TBG says the tests take up to 15 minutes to complete and detect COVID-19
- TBG Diagnostics is still in a trading halt after a sudden spike in its share price, which the company claims was due to its investee company receiving CE mark approval
- Company shares last traded for 27 cents each on March 17
TBG Diagnostics (TDL) has announced its subsidiary, TBG Biotechnology, 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.
Both tests are manufactured by TBG Biotechnology in Taiwan and will be exported from there to the destination country.
TBG says the tests take up to 15 minutes to complete and detect the presence of SARS-CoV-2 specific antibodies, IgM and IgG, 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 seven to 10 days after SARS-CoV-2 infection and can last for weeks,” the company explained.
This rapid test uses droplets of blood, serum or plasma as test samples.
TBG Diagnostics is still in a trading halt after a sudden spike in its share price, which the company claims was due to its investee company receiving CE mark approval.
Company shares last traded for 27 cents each on March 17.