Mico BioMed Obtains MFDS Approval for COVID-19 and Influenza Simultaneous Diagnostic Kit

[Asia Economy Reporter Lee Gwan-joo] MikobioMed announced on the 13th that it has obtained product approval from the Ministry of Food and Drug Safety for a simultaneous diagnostic kit for COVID-19 and influenza (Influenza A/B).

The product that received domestic manufacturing approval this time (Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit, CoVFLU-VM) is a PCR diagnostic product that can simultaneously diagnose COVID-19 and influenza through upper respiratory specimens from patients suspected of respiratory infectious diseases.

In terms of performance, for COVID-19, the clinical sensitivity was 96.82% when using nasopharyngeal swabs, and 100% when using both nasopharyngeal and oropharyngeal swabs, with clinical specificity of 100% for both specimen types. For Influenza A and B, high sensitivities of 100% and 97.14%, respectively, were secured using nasopharyngeal swabs, and clinical specificity was 100%.

The simultaneous diagnostic kit is expected to be effective in responding to the 'twindemic' of simultaneous outbreaks of COVID-19 and influenza. Sungwoo Kim, CEO of MikobioMed, said, “By quickly reading changes and directions in the rapidly evolving market environment and proactively developing and obtaining approval for products that meet needs, we will solidify our leading position in the in vitro diagnostics field.”

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