Seasun Biomaterials Secures FDA Emergency Use Authorization for Second COVID-19 Rapid Detection Kit

By LabMedica International staff writers
Posted on 25 May 2020

Seasun Biomaterials, Inc. (Daejeon, Korea) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its second COVID-19 assay AQ-TOP COVID-19 Rapid Detection Kit following the completion of FDA EUA (April-27) of its U-TOP COVID-19 Real-Time Detection Kit.

The AQ-TOP technology enhances analytical speed, sensitivity and specificity of the conventional molecular methods by combining isothermal amplification and PNA (Peptide Nucleic Acid) detection probe, which has high accurate binding efficiency to the target nucleic acid. This kit targets the ORF1ab gene of the SARS-CoV-2 with an endogenous control human RNase P gene. Customers need not purchase any additional equipment and can use their existing real-time PCR instrument which is frequently used for COVID-19 diagnosis. The average number of specimens that can be tested per unit (12 hours per day) is 3,400, which is 5-6 times faster than before. The company now plans to provide the kit globally and hopes that its advantage of rapid COVID-19 diagnosis will contribute to quick follow up.