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Boston Children's Coronavirus Test Gets Emergency Use Authorization

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for a PCR-based SARS-CoV-2 test developed by Boston Children's Hospital.

The Childrens-Altona-SARS-CoV-2 assay is designed to detect one target sequence of the SARS-CoV-2 spike glycoprotein gene in nasopharyngeal, oropharyngeal, nasopharyngeal/ oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens. The test is used with Qiagen's Virus MinElute Spin viral RNA/DNA purification kit performed on the QiaCube extraction platform, the company's Qiagility automated PCR setup instrument with software version 4.17.1, and its Rotor-Gene Q 5Plex instrument with software version 2.3.1.

According to the FDA, the test is to be performed at Boston Children's infectious diseases diagnostics laboratory.