Mico BioMed Obtains Export Approval for COVID-19 Neutralizing Antibody Rapid Diagnostic Kit and Analysis Equipment

[Asia Economy Reporter Lee Gwan-joo] MikobioMed announced on the 28th that it has obtained export approval for the COVID-19 neutralizing antibody rapid test kit and an analytical device that can quantify the neutralizing antibody titer (concentration).

The neutralizing antibody rapid test kit (VERI-Q SARS-CoV-2 Neutralizing Antibody Rapid Test Kit), which received export approval this time, can confirm the presence of neutralizing antibodies within 15 to 20 minutes using a drop of capillary blood collected from a fingertip, similar to a blood glucose meter.

Additionally, MikobioMed developed a reader (VERI-Q PinoView) that can determine positive or negative results based on the neutralizing antibody titer, and obtained export approval for it along with the test kit.

The clinical sensitivity and specificity of the test kit when read visually are 98.7% and 97.4%, respectively. It has been confirmed that the same performance is demonstrated when using the analytical device.

Following the acquisition of the European CE certification for the test kit in August last year, MikobioMed completed import registration with the German Federal Institute for Drugs and Medical Devices (BfArM) last month. Currently, there is no neutralizing antibody test kit officially approved by the Ministry of Food and Drug Safety in Korea.

Kim Sung-woo, CEO of MikobioMed, stated, “Our company has completed the development of various COVID-19 neutralizing antibody test kits, enabling immediate response to all variables in future quarantine policies,” and added, “We are striving to obtain domestic product approval for neutralizing antibody diagnostic products as soon as possible.”

This content was produced with the assistance of AI translation services.