1drop's 1copy COVID-19 qPCR Multi Kit Granted Emergency Use Authorization by FDA

By LabMedica International staff writers
Posted on 14 May 2020

1drop Inc. (Gyeonggi-do, Korea) has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the company’s 1copy COVID-19 qPCR Multi Kit.

The 1copy COVID-19 qPCR Multi Kit allows for the qualitative detection of SARS-CoV-2 by amplification of two target genes (E gene and RdRp gene) of the virus causing COVID-19 with real-time qPCR (including reverse-transcription reaction) via RNA extracted from clinical specimens (nasopharyngeal swabs or oropharyngeal swabs) of suspected respiratory infectious disease patients. RdRp is the SARS-CoV-2 specific detection target, and the E gene is detection target specific to the beta coronavirus.

Image: 1copy COVID-19 qPCR Multi Kit (Photo courtesy of 1drop Inc.)

In addition to its extremely high sensitivity (limit of detection of 200 copies per mL), the PCR kit has a short measurement time that allows to obtain results in less than two hours. Hospitals and reference laboratories can run the new assay on a wide range of Real-Time PCR Instruments which are widely available across the world. The 1copy COVID-19 qPCR Multi Kit is presently approved and/or commercialized in several countries, including Germany, South Korea, Sri Lanka, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.

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