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FDA Clears Home Covid-19 Diagnostic Test

Coronavirus graphic

(Pete Linforth, Pixabay)

21 Apr. 2020. The Food and Drug Administration today granted an emergency authorization for a Covid-19 diagnostic test performed at home and sent back to a lab. The test is designed by Laboratory Corporation of America or LabCorp in Burlington, North Carolina, a medical diagnostics company operating in most parts of the U.S.

FDA’s Emergency Use Authorization, or EUA, permits LabCorp. to provide its Pixel Covid-19 home test kit to individuals exposed to or suspected of coronavirus infections. Most current Covid-19 diagnostic tests use a nasopharyngeal swab that collects specimens of nasal secretions at the back of the throat. The swabs are inserted by a clinician through the patient’s nose to the region where the throat meets the roof of the mouth.

To perform the current tests, clinicians need to be fully protected against Covid-19 infections, which requires wearing masks, gloves, disposable gowns, and face shields. In addition, materials for these tests, such as the special swabs and reagents, are in short supply and difficult to acquire in many sections of the country, forcing health authorities to seek those materials from outside their usual channels. Yesterday, for example, Maryland’s governor announced the state purchased 500,000 test kits from a supplier in Korea.

LabCorp’s Pixel test requires individuals to first complete an online questionnaire to determine their eligibility for receiving a test kit, with the entries reviewed by an independent physician from PWNHealth, a national network of clinicians using telemedicine for diagnostic testing. If eligible for the test, a kit is sent to the person’s home. When received, the individual uses a Q-tip-style cotton swab provided in the kit. The person swirls the swab around both nostrils to collect a specimen, then returns the swab in an insulated pouch to LabCorp for genetic analysis to detect evidence of SARS-Cov-2 viruses.

LabCorp expects to initially make Pixel tests available to health care workers and first responders exposed to people with Covid-19 infections, or already showing symptoms. The company anticipates the tests will be available to the public at large in a few weeks. LabCorp’s web site says results take one to two days after receipt by the lab and are provided online, although that time may vary depending on the demand.

FDA Commissioner Stephen Hahn says in a statement that the agency “worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital, or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

The kits have a list price of $119.00 and are available nationwide, except in the states of New York, New Jersey, Maryland, and Rhode Island. Science & Enterprise asked LabCorp for the reasons those states are excluded from the Pixel tests. We will update this story when we receive an answer.

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