We are excited to announce that Boditech Med’s COVID-19 neutralizing antibody diagnostic kit (ichroma™ COVID-19 Neutralizing Ab) it has obtained an export license from the Ministry of Food and Drug Safety of Korea. It can diagnose the activity of neutralizing antibodies within 20 minutes.
The sensitivity and specificity of this product confirmed by the PRNT (plaque reduction neutralization test) method, a standard test for evaluating the activity of neutralizing antibodies in the blood after vaccination, were both 99%, demonstrating equivalent performance to the neutralizing antibody diagnostic products of the enzyme immunization (ELISA) method.
As the approved product has also completed verification of use of all vaccines supplied worldwide, it can be supplied to all regions of the world regardless of the vaccination status of each country.
CE certification for sales in Europe has been completed, and product registration for two neutralizing antibody diagnostic kits of Boditech Med has been completed with ANVISA (Health Regulatory Agency) of Brazil, where the number of confirmed cases is increasing recently. In addition, clinical trials are in progress in the US to apply for emergency use authorization (EUA) by the US FDA, and the licensing process in Asia, such as Indonesia and the Philippines, is in the final stages.
A company official said, “as the neutralizing antibody diagnostic kit is a product that checks the activity of neutralizing antibodies after vaccination, high accuracy is essential. Boditech Med's products have the advantage of being able to identify within 20 minutes on site with high accuracy, so they can be widely used in airports, railways, schools, and ports in major countries. Approval for official use in Korea is also in progress, and it is expected that the approval process will be completed within this year.”