FDA grants EUA to Thermo Fisher for pooled SARS-CoV-2 testing

June 2, 2021

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Thermo Fisher Scientific for the TaqPath COVID-19 Pooling Kit, a real-time PCR multiplex test.

The TaqPath COVID-19 Pooling Kit can detect the presence of SARS-CoV-2 in a single reaction containing up to five combined samples and can also be used for the deconvolution (retesting) of positive pools. The test has a turnaround time of less than four hours.

The test kit is designed for use with individual nasopharyngeal, oropharyngeal, anterior nasal, or mid-turbinate nasal swabs in which specimens are collected by a healthcare provider (HCP) using individual vials containing transport media.

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