SEASUN BIOMATERIALS Launches COVID-19 Rapid Molecular Assay

SEASUN BIOMATERIALS (Seoul, South Korea) has released its second COVID-19 assay AQ-TOP COVID-19 Rapid Detection Kit following the completion of FDA EUA (April-27) of the company’s 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. The kit obtained CE-IVD marking in March, and now examinations of an export approval of MFDS (Korea's Ministry of Food & Drug Safety) and the FDA EUA are underway.

“Customers don't need to purchase additional equipment. The existing real-time PCR instrument which is frequently used for COVID-19 diagnosis can be used as it is. 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,” said CEO Hee-Kyung Park. “Currently, as COVID-19 is rapidly spreading globally and re-infection is reported frequently, we will produce more than 200,000 tests per day to deliver as fast as possible. As soon as the permit for the AQ-TOP COVID-19 Rapid Detection Kit has been completed, the kit will be provided globally and with the advantage that the rapid COVID-19 diagnosis will contribute to quick follow-up.”

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