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Laboratorio Clinico Toledo, Assure Tech Coronavirus Tests Get Emergency Use Authorizations

NEW YORK — The US Food and Drug Administration on Monday granted separate Emergency Use Authorization for SARS-CoV-2 tests developed by Laboratorio Clinico Toledo and Assure Tech.

The Laboratorio Clinico Toledo SARS-CoV-2 Assay is designed to detect the virus' nucleocapsid gene, as well as the SARS-like coronavirus E gene and RdRP, in upper respiratory and bronchoalveolar lavage specimens. It uses Roche's MagNA Pure 96 nucleic acid purification system and runs on the Roche Light Cycler 480 PCR instrument.

According to the FDA, the test may only be performed by Puerto Rico-based Laboratorio Clinico Toledo.

Assure Tech's Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay designed to detect immunoglobulin G and M antibodies against SARS-CoV-2 in venous whole blood, serum, or plasma. Results are provided within 15 minutes, according to the Hangzhou, China-based company.

Assure Tech's test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.