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FDA Grants Emergency Use Authorizations for Quadrant Biosciences, KimForest Coronavirus Tests

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Quadrant Biosciences and KimForest Enterprise.

Quadrant's Clarifi COVID-19 Test Kit is designed to detect two sequences of the SARS-CoV-2 RdRp gene in saliva swab specimens collected by a healthcare provider using DNA Genotek's ORACollect RNA kit.

Nucleic acid extraction is performed using Zymo Research's Quick-RNA Viral 96 Kit and the test runs on either Bio-Rad Laboratories' CFX96 or CFX384 Touch RT-PCR Detection Systems or Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 RT-PCR System, according to Syracuse, New York-based Quadrant.

Gene On Link's KimForest SARS-CoV-2 Detection Kit v1 is designed to detect the RdRp gene of the virus in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swabs, as well as nasopharyngeal washes, nasopharyngeal or nasal aspirates, and bronchoalveolar lavage specimens collected by a healthcare provider.

The test uses Qiagen's QIAamp Viral RNA Mini Kit for nucleic acid purification and runs on Thermo Fisher's Applied Biosystems StepOne or StepOnePlus RT-PCR Systems, according to New Taipei City, Taiwan-based KimForest. It is distributed in the US by Diamond Bar, California-based Arbelos Genomics.

Both tests may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

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