The Health Board (Terviseamet) has issued an IVD CE validation mark to a diagnostic test developed by a private sector firm, which allows the identification of SARS-CoV-2 antibodies in blood samples. This can determine whether or not an individual has been infected with COVID-19 at any time.
The validation was issued on September 3.
At present, longer-term surveys are underway to find out about the duration of the immunity acquired against COVID-19 and potential protection against future infection.
Although the company, Icosagen, is not engaging in the development of a vaccine, these surveys are expected to offer a better picture of the possibility of the use of any vaccine, and the duration of the acquired antibody immunity.
The test in development is based on recombinant virus proteins produced by Icosagen and it has been developed in Tartu. The test approved by the Health Board uses the enzyme-linked immunosorbent assays (ELISA) method.
Mart Ustav, founder and CEO of the company, said: "We are no longer producing bolts and nuts for medical equipment as a mere sub-contractor, but are now capable of developing, clinically validating and producing also diagnostic tests."
Ustav added that the company was also planning to develop a SARS-CoV-2 antigen test and an ELISA test of COVID-19 neutralizing antibodies.
The SARS-CoV-2 antigen test being currently developed would enable to find out about potential infection in the early stage of the infection by means of testing a saliva sample from the patient, thus offering a rapid and favorably priced alternative to the current RNA test.
With the help of the COVID-19 neutralizing antibodies ELISA test it will be possible to determine the presence of specific virus neutralizing antibodies in a patient's blood serum. In a situation where it is possible that the vaccines against SARS-CoV-2 that are being developed create immunity only for a specific period of time, that test will potentially enable to determine the strength and durability of the immunity created by the vaccine.
The test also enables medical institutions to choose from among the blood serums of patients who have recovered from the disease the serums that are the most effective for neutralizing the virus, which they would use in the treatment of critical patients.
The Ministry of Social Affairs has provided €100,000 in total towards the development of the newly certified test and the tests still under development.
Editor: Kristjan Kallaste