AndyForce Receives Export Approval for Integrated COVID-19 and Influenza Antigen Rapid Test Kit
[Asia Economy Reporter Hyunseok Yoo] AndyForce announced on the 29th that it has obtained export approval from the Ministry of Food and Drug Safety (MFDS) for the antigen rapid diagnostic kit ‘ND COVID-19 & FLU DUO Plus,’ which can simultaneously diagnose novel coronavirus infection (COVID-19) and influenza viruses.
The product that received export approval this time is an upgraded version of the COVID-19 and influenza antigen simultaneous rapid diagnostic kit ‘ND COVID-19 & FLU Duo,’ which obtained export approval last November.
While it still uses nasopharyngeal swab specimens to determine infection with COVID-19 and influenza A and B viruses within 15 minutes, it significantly improves the specimen collection process by reducing it to a single collection, compared to the previous method that required two separate collections. In addition to the convenience of being an integrated kit, it achieved excellent clinical trial results with a sensitivity of 94.7%, specificity of 100%, and accuracy of 97.4%.
An AndyForce official stated, “This product was developed to quickly respond to market demands regarding the inconvenience caused by multiple specimen collections during simultaneous diagnosis,” and added, “This new product is also expected to be effective against the UK-origin COVID-19 variant ‘VOC-202012/01,’ which has recently emerged worldwide with some genetic mutations.”
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He continued, “The UK variant is known to have 40-70% higher transmissibility compared to the original virus, making rapid initial response crucial, so high demand is expected,” and added, “Along with the MFDS export approval, import approvals for export are also being processed in each requesting country, so exports are expected to accelerate rapidly from this approval onward.”
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