Icosagen's COVID-19 antibody ELISA test is available for diagnostics with an IVD CE mark
On September 3rd the Health Board registered our developed diagnostic test with the IVD CE mark. The test can be used to detect antibodies against SARS-CoV-2 in human blood samples to determine if a person has had the disease. Volunteers recovered from COVID-19, whose donated blood was used to validate the test, played a very important role in the validation of the test. Long-term studies are underway to determine the duration of antiviral immunity associated with COVID-19 and possible protection against future infections. Although the company is not developing the vaccine, these studies also provide a better understanding of the possibility of using the vaccine and the duration of the antibody immunity against SARS-CoV-2. The test is based on recombinant viral proteins produced by Icosagen and has been developed in Tartu. The test works by enzyme-linked immunosorbent assay (ELISA), allowing the semi-quantitative in vitro detection of IgG and IgM antibodies against SARS-CoV-2 virus in human serum or plasma (Medical Device Database (MSA) code 15531). All antigens used for the test are also available in our catalogue.
"The validation of the COVID-19 ELISA test is an important milestone in our company’s development, which we have reached through the joint efforts of Icosagen staff, volunteer donors and partners, such as the Government of Estonia, which contacted us to provide assistance." commented Mart Ustav, founder and CEO of Icosagen. “We are no longer only a subcontractor to produce bolts and nuts for medical devices, but we are now able to develop, clinically validate and produce diagnostic tests. We do not intend to dwell here satisfactorily, but are also developing the SARS-CoV-2 antigen test and the COVID-19 neutralizing antibody ELISA test. "
The SARS-CoV-2 antigen assay in development allows the detection of SARS-CoV-2 virus in a patient's saliva sample at an early stage of infection, providing a rapid and cost-effective alternative to the current RNA assay. And the second test in development - the COVID-19 neutralizing antibody ELISA - can specifically detect the presence of virus neutralizing antibodies in patients' blood serum and makes it possible to determine the strength and duration of the immunity elicited by the vaccine. In addition, this test allows medical authorities to select highly neutralizing sera from the blood sera of patients who have recovered from the disease, for use in the treatment of critically ill patients.
The Ministry of Social Affairs of the Republic of Estonia supported the creation of the newly approved tests, which are still under development, with 100,000 euros.