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Spectrum Solutions Saliva Collection Device, Access Bio, Genalyte Coronavirus Tests Get FDA EUAs

NEW YORK — The US Food and Drug Administration on Thursday granted separate Emergency Use Authorizations (EUAs) for Spectrum Solutions' saliva collection device for SARS-CoV-2 tests, as well as SARS-CoV-2 tests developed by Access Bio and Genalyte.

Spectrum's SDNA-1000 Saliva Collection Device consists of a plastic tube designed for the collection of human saliva samples suspected of containing SARS-CoV-2 RNA, a funnel, a cap with a stem flare, and a fluid chamber containing a patented stabilizing solution, according to the FDA.

It has been evaluated with various RNA extraction chemistries including PerkinElmer's Chemagic Viral DNA/RNA 300 Kit, Thermo Fisher Scientific's MagMax Viral/Pathogen II Nucleic Acid Extraction Kit, Qiagen's QIAsymphony DSP Virus/Pathogen Midi Kit, and Roche's Magna Pure LC Total Nucleic Acid Isolation Kit.

The device may be manufactured only by Draper, Utah-based Spectrum. It is used with DxTerity Diagnostics' DxTerity SARS-CoV-2 RT-PCR CE Test and RUCDR Infinite Biologics' saliva-based SARS-CoV-2 test.

Access Bio's CareStart COVID-19 Antigen test is a visually read lateral flow immunochromatographic assay designed to detect the nucleocapsid protein antigen from SARS CoV-2 in nasopharyngeal swab specimens. Results are provided in 10 minutes, according to Access Bio.

The test may be used by labs that are CLIA-certified to perform high-, moderate-, or waived-complexity tests, and is authorized for point-of-care use, the FDA said.

In July, Somerset, New Jersey-based Access Bio received EUAs from the FDA for its CareStart COVID-19 IgM/IgG SARS-CoV-2 test and its CareStart COVID-19 MDx RT-PCR test

Genalyte's Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 is designed to detect total antibodies, including immunoglobulin G and M, against the virus in whole blood, plasma, and serum. It runs on the San Diego-based company's Maverick Detection System, which uses photonic ring resonance technology for rapid blood testing.

The test may be used by labs CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.