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Sinochips Bioscience Gets FDA Emergency Use Authorization for Coronavirus Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Sinochips Bioscience.

The COVID-19 Nucleic Acid RT-PCR Test Kit is designed to detect the ORF1ab and nucleocapsid genes of the virus in upper respiratory specimens, according to the Zhuhai, China-based company. It uses Qiagen's QIAamp Viral RNA Mini Kit for manual nucleic acid extraction or Thermo Fisher Scientific's KingFisher Flex Magnetic Particle Processor for automated extraction and runs on Thermo Fisher's Applied Biosystems 7500 Fast Dx or Applied Biosystems 7500 RT-PCR instruments.

The test may be used by any lab CLIA-certified to perform high-complexity testing, the FDA said.

The Scan

Gone, But Now Reconstructed SARS-CoV-2 Genomes

In a preprint, a researcher describes his recovery of viral sequences that had been removed from a common database.

Rare Heart Inflammation Warning

The Food and Drug Administration is adding a warning about links between a rare inflammatory heart condition and two SARS-CoV-2 vaccines, Reuters reports.

Sandwich Sampling

The New York Times sent tuna sandwiches for PCR analysis.

Nature Papers Describe Gut Viruses, New Format for Storing Quantitative Genomic Data, More

In Nature this week: catalog of DNA viruses of the human gut microbiome, new dense depth data dump format to store quantitative genomic data, and more.