AndyForce Obtains European CE Certification for COVID-19 Rapid Test Kit... "Human-Compatible Antigen, Maximizing Accuracy"

[Asia Economy Reporter Hyunseok Yoo] AndyForce announced on the 3rd that it has completed European certification for the novel coronavirus disease (COVID-19) rapid diagnostic kit ‘ND COVID-19 IgG/IgM Rapid Test’.

The antibody rapid diagnostic kit that obtained European certification this time is a diagnostic device that uses immunoassay to test for the presence of COVID-19 specific antibodies in the blood. It allows antibody diagnosis within 15 minutes using only a very small amount of blood, making it advantageous for assessing herd immunity levels and the scale of asymptomatic infections.

Rapid diagnostic kits have seen increasing demand mainly in countries with relatively poor infrastructure, as they enable identification of COVID-19 confirmed cases without diagnostic equipment or specialized medical personnel amid the prolonged spread of COVID-19.

In particular, AndyForce’s antibody rapid diagnostic kit boasts an excellent accuracy rate of up to 90% compared to molecular diagnostic kits. Generally, the accuracy of antibody tests in rapid diagnostic kits is only 60-70%.

An AndyForce official emphasized, “AndyForce’s rapid diagnostic kit detects COVID-19 IgG/IgM using immunological methods by isolating and purifying the COVID-19 antigen not from Escherichia coli, which was mainly used previously, but from ‘insect cells’ that are closer to human structures. Therefore, it has superior biological characteristics compared to existing methods and is optimized to confirm infection status in humans. This results in significantly higher accuracy than existing products.”

He added, “Starting from this approval, we plan to actively export the diagnostic kits overseas and develop a multiplex diagnostic platform capable of simultaneously diagnosing COVID-19 and various forms of viral infections by utilizing molecular diagnostic and immunodiagnostic development technology platforms. We are also developing diagnostic technology that enables biochemical testing of COVID-19 specific antibodies (IgM/IgG), aiming to prioritize products that can simultaneously reduce diagnostic time and improve accuracy.”

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