Seasun Biomaterials has announced that it is about to release its second Covid-19 assay, the AQ-TOP COVID-19 Rapid Detection Kit. The announcement comes days after the company received a US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its U-TOP COVID-19 Real-Time Detection Kit.
The new kit enhances the speed, sensitivity and specificity of conventional molecular detection methods by combining isothermal amplification with a PNA detection probe. This has a highly accurate binding efficiency to the nucleic acid the kit targets. Specifically, it searches for the presence of the ORF1ab gene of the SARS-CoV-2 virus, with an endogenous control human RNase P gene.
The AQ-TOP kit received CE marking in March.
Seasun Biomaterials CEO Hee-Kyung Park said: “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.”