Humasis Obtains European CE-IVD Certification for COVID-19 Antigen Test Kit...Exports Expected to Begin in Earnest

[Asia Economy Reporter Park Jihwan] Humasis, a field-type rapid testing specialist company, announced on the 11th that its novel coronavirus (COVID-19) antigen diagnostic kit obtained the European CE-IVD certification for in vitro diagnostic medical devices as of the 10th.

Humasis's new antigen diagnostic kit was developed in collaboration with Celltrion. It applies antibodies that recognize the virus's specific surface antigens. This allows the infection status to be diagnosed within 15 minutes using nasopharyngeal swab specimens from suspected early patients.

Following the export approval of the antigen diagnostic kit product from the Ministry of Food and Drug Safety on the 8th, Humasis also acquired the European CE certification, enabling full-scale exports to Europe and other countries where the certification applies.

The company plans to begin sales of the COVID-19 antigen diagnostic kit as soon as registration procedures are completed in countries such as Poland, Romania, Italy, the United Kingdom, Brazil, Colombia, the Philippines, and Indonesia.

A Humasis official stated, "The demand in the rapid diagnostic market for COVID-19 is rapidly expanding from antibody diagnostics to antigen diagnostics," adding, "As requests for antigen diagnostic kits are increasing mainly from partners in various countries, we will make every effort to ensure prompt supply."

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