SugenTech Receives Manufacturing and Export Approval for COVID-19 and Influenza Simultaneous Diagnostic Product

SugenTech CI (Photo by SugenTech)

[Asia Economy Reporter Chunhee Lee] SuzenTech announced on the 8th that it has received manufacturing approval for export of Class 3 in vitro diagnostic medical devices for simultaneous diagnosis of COVID-19 and Influenza A and B from the Ministry of Food and Drug Safety.

This approval is limited to export-only in vitro diagnostic medical devices, with the product names 'SGTi-flex COVID-19 & Flu A/B Ag' and 'SGTi-flexM COVID-19 & Flu A/B Ag.' In clinical trials, the sensitivities for COVID-19 and Influenza A and B were 90%, 92%, and 93%, respectively, and the specificity was confirmed to be 100% for all.

Both products enable simultaneous reading of COVID-19 and influenza. Unlike existing products that required separate detection of COVID-19 and Influenza A and B viruses, these products can test for all three viruses on a single strip. This enhances customer convenience and provides advantages in manufacturing costs. In particular, the technology applying nanobeads of various colors was incorporated to maximize ease of interpretation for users.

A company representative stated, “For long-term COVID-19 response, treatment and diagnosis must be distinguished from influenza,” adding, “We recognized the necessity of in vitro diagnostic medical devices capable of differentiating COVID-19 and Influenza A and B viruses and proactively obtained manufacturing approval.”