New & Noteworthy

January 2023

COVID-19 Home Testing Kit


The US FDA has issued an expanded EUA for the Rheonix COVID-19 MDx Assay to include home collection using the Rheonix COVID-19 PCR Test Saliva Home Collection Kit. The fully automated, sample-to-answer COVID-19 assay received its initial EUA for use on a range of respiratory specimens in 2020. The EUA has subsequently been expanded to include use of saliva as a sample type and use by both moderate- and high-complexity laboratories. The rtest has been confirmed to detect the omicron subvariants, including BA.5.

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