NowCheck COVID-19 Spike IgG Test Obtains CE Mark … Awaiting for the U.S. FDA EUA




| The SARS-CoV-2 Antibody for Spike IgG can be detected within 15 minutes

| Completed CE mark certification and is awaiting FDA Emergency Use Authorization.


Bionote has announced the acquisition of CE marking for its NowCheck COVID-19 Spike IgG Test to detect specific antibodies to SARS-CoV-2. This is the company’s third addition to the existing COVID-19 product portfolio, following the NowCheck COVID-19 Ag Test and COVID-19 IgM/IgG Test.


Antibody rapid diagnostic test is a widely used screening method for determining antibodies in the blood of people who have been previously infected with or vaccinated against a virus that causes a disease. The test procedure for a rapid test is simple, fast, and efficient, requiring only 15 to 30 minutes without the need for any additional equipment.


COVID-19 vaccines are becoming mandatory in many countries around the globe, and among the vaccines, the major type is the mRNA vaccine which uses the spike protein. As the number of people receiving the COVID-19 mRNA vaccine increases, the demand for COVID-19 antibody testing is also growing.


Currently, the plaque reduction neutralization test (PRNT) is considered the gold standard for measuring levels of the antibodies for many viral diseases, but as the PRNT requires biological safety level 3 laboratory (BSL3), this testing method has limitations with wide implementation. Compared to the PRNT test, antibody rapid diagnostic test can quickly be performed without any need for a standardized environment.


Bionote’s NowCheck COVID-19 Spike IgG Test can detect specific antibodies against SARS-CoV-2 within 15 minutes. This test also demonstrated high accuracy in the clinical evaluation using a total of 102 serum specimens, with percent positive agreement of 82% (41/50) and percent negative agreement of 100% (52/52).


Bionote is expecting the demand for COVID-19 antibody testing to continue to increase as more people receive vaccination and begin to realize the importance of immunity. The company is planning to launch its NowCheck COVID-19 Spike IgG Test in the U.S. market soon after its completion of the U.S FDA EUA.


For those who are interested in NowCheck COVID-19 Tests, please contact your local distributor or mail to [].