Credo Diagnostics Biomedical Pte. Ltd. announced today that it has obtained the CE Mark for its SARS-CoV-2 Assay. The rapid point-of-care molecular test for the novel Coronavirus COVID-19 is now commercially available in markets recognizing the designation.
Leveraging its real-time PCR point-of-care platform VitaPCR™, the test allows the detection of SARS-CoV-2 in 20 minutes with a hands-on time of 1 minute. The versatile platform can be deployed anywhere from laboratory to near-patient setting and other high-risk locations, including airports and seaports, with minimal training and no additional equipment needed.
“We need to provide better tools for the medical personnel in the first line of defense. They should be equipped with more than thermal scanners. I believe rapid and accurate molecular screening of COVID-19 strain will better help contain the virus and allow early actions to be taken, thus preventing tragedies.” said Dr. Winston Wong Jr., Chairman of Credo Diagnostics Biomedical.
VitaPCR™ SARS-CoV-2 Assay is also pending Emergency Use Authorization from the US FDA and Emergency Use Listing from the WHO.
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