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Color Health, Yale Get FDA Emergency Use Authorization for Coronavirus Sample Collection Kits

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for sample collection kits for SARS-CoV-2 testing from Color Health and the Yale School of Public Health.

The Color COVID-19 Self-Swab Collection Kit with Saline is designed for the self-collection of anterior nasal swab specimens by adults either at home or in a healthcare setting. Collected samples, which may include viral RNA, are maintained in saline for transport to a Color-designated lab for molecular testing, according to the FDA.

Last month, Burlingame, California-based Color received EUA from the FDA for a direct-to-consumer versions of Color Health's loop-mediated isothermal amplification-based SARS-CoV-2 test and a companion nasal swab sample self-collection kit. 

Yale's SalivaDirect At-Home Collection Kit is designed for the unsupervised self-collection of saliva samples from adults at home. Samples are transported at ambient temperature for molecular diagnostic testing at a Yale School of Public Health-designed lab, the FDA said.