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Devices

Some test devices that are part of the COVID-19 Test Us initiative are described below. These devices are being tested around the country.  The availability of these devices may vary depending on location.  Of the devices tested by the COVID-19 Test Us initiative, three devices have received FDA Emergency Use Approval (EUA).  We have assisted the following companies with products that have received EUA authorization: Quidel, Quanterix and Mesa Biotech Inc..

Maxim Biomedical Inc

Maxim SARS-CoV-2 Antigen Rapid Test

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A single-use, lateral-flow test strip immunoassay that can provide results in 15 minutes or less. With the improved workflow, the assay can be performed without an instrument for reading and does not require any specialized equipment.

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Founded in 2005 as a branch of the Maxim family of businesses, Maxim Biomedical was created as a company dedicated to the development of high quality, in-vitro diagnostic (IVD) and Point-of-Care (POC) testing solutions that make positive contributions to public health and healthcare worldwide.

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Mesa Biotech, Inc.

Accula™ SARS-CoV-2 Test

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This test employs a hand-held RT-PCR device and a compact, single-use cartridge that detects viral RNA at the point of care. Results can be read from the removable cartridge in 30 minutes.

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Mesa Biotech designs, develops, manufactures and commercializes next generation rapid molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care.

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Quanterix

Simoa SARS-CoV-2 Antigen N Protein Antigen Test

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A laboratory antigen test with ultra-sensitive single-molecule immunoassay technology to enable detection from a variety of sample types including nasopharyngeal, saliva or self-acquired blood from a finger prick. Sample collection, transport, and processing will occur within 24-48 hours using existing sample collection logistics infrastructure through a network of centralized labs.

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Quanterix is dedicated to the sustainable delivery of high quality, innovative biomarker measurement products and testing services that meet our customer needs and regulatory requirements.

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