US BioTek Laboratories Launches COVID-19 Testing Services
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.
SHORELINE, Wash., July 13, 2020 /PRNewswire-PRWeb/ -- 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 (https://www.fda.gov/media/137922/download) 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 (https://www.fda.gov/media/138071/download) 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 https://www.usbiotek.com/covid-19-tests.
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 http://www.usbiotek.com.
US BioTek Laboratories has received approval from the Washington State Department of Health to perform COVID-19 RT-PCR and antibody tests (https://www.usbiotek.com/hubfs/Licenses%20and%20Certificates/US%20BioTek%20COVID-19%20WA%20DOH%20Approval.pdf). 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.
SOURCE US BioTek Laboratories
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