US BioTek Laboratories Launches COVID-19 Testing Services

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US BioTek Laboratories, a CLIA accredited laboratory, is now offering two FDA Emergency Use Authorized COVID-19 tests, one using RT-PCR technology to detect the virus that causes COVID-19 and one serological test to detect antibodies to the virus.

US BioTek Laboratories, a CLIA (Clinical Laboratory Improvement Amendments) accredited laboratory, announces that it has expanded its capabilities to include coronavirus testing. Best known as a provider of immunology profiles used to identify food and airborne allergies and sensitivities, US BioTek performs FDA EUA authorized diagnostic (RT-PCR) and antibody tests for COVID-19 at its Shoreline, WA facility. Available for use by licensed healthcare providers, the addition of COVID-19 testing comes at a time when many US labs are reaching or near capacity, resulting in long wait times for patient results. US BioTek can serve as an additional COVID-19 testing resource anywhere in the country and help healthcare providers accelerate the process for their patients, with turnaround times of typically 24-48 hours including shipping.

“As the magnitude of COVID-19 became apparent, we recognized that we had a unique capability to provide much needed testing,” said Jack Frausing, CEO of US BioTek Laboratories. “We have a modern, state-of-the-art lab and trained staff already in place, so adding this much-needed service was an easy decision. We are pleased to be able to do our part in the fight against the virus.”

US BioTek’s COVID-19 Diagnostic Test has received FDA EUA authorization ( and is performed on a Thermo Fisher system using real-time reverse polymerase chain reaction (RT-PCR) technology to detect the presence of the SARS-CoV-2 virus in a patient, the current standard for identifying infected individuals. The test is performed using a sample collected from a patient by nasopharyngeal, oropharyngeal, nasal mid-turbinate, or anterior nasal swab. Additional collection methods are currently under review and will be supported by US BioTek once approved for use by the FDA.

US BioTek also offers a serological test to detect antibodies to the virus. This test has also received FDA EUA ( and is performed on a high sensitivity electro chemiluminescent platform developed by Roche, and the test may help to identify prior exposure to the SARS-CoV-2 virus. It can also be used to confirm a COVID-19 test result performed on a PCR system, particularly when a false-negative result is suspected due to inadequate sample collection.

More information on both tests can be found on US BioTek Laboratories’ website at

About US BioTek Laboratories
US BioTek Laboratories, Inc. is a Clinical Laboratory Improvement Amendments (CLIA) accredited testing facility headquartered north of Seattle in Shoreline, Washington. With over 30 years’ experience in enzyme-linked immunosorbent assay technology, it employs the latest laboratory science, advanced automation technology, and a dedicated research team to ensure the accuracy and reproducibility of each test it performs. More information is available at

US BioTek Laboratories has received approval from the Washington State Department of Health to perform COVID-19 RT-PCR and antibody tests ( As stated in Section IV.B of the FDA's Policy for Coronavirus Disease-2019 Tests, a State or territory choosing to authorize laboratories within that State or territory to develop and perform a test for COVID-19 would do so under authority of its own State law, and under a process that it establishes. As noted in the guidance, FDA does not intend to object to the use of such tests for specimen testing where the notification of SARS-CoV-2 test validation is not submitted to FDA and the laboratory does not submit an EUA request to FDA, and where instead the State or territory takes responsibility for COVID-19 testing by laboratories in its State/territory during the COVID-19 outbreak. The Washington State Department of Health has notified FDA that they choose to use this flexibility to expedite COVID-19 testing.

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Jenni Bednarz
since: 06/2019
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