MELVILLE, NY — A Long Island-based medical supply distributor said it plans to distribute rapid test kits for the new coronavirus across the United States as early as Monday. Henry Schein, based in Melville, is working to ship tests as quickly as possible in response to the urgent need for rapid, accurate testing, the company announced Thursday.

The distributor plans on having at least several hundred thousand tests available by Monday, with widespread availability beginning in April. The firm is prioritizing the U.S. market and will address the potential to distribute the tests internationally at a later date, a company spokeswoman told Patch. The antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test, is meant to be administered at the point of care. Results are delivered within 15 minutes from a pinprick with no instrumentation required, according to the company.

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The test is being made available under emergency guidance issued by the U.S. Food and Drug Administration, according to the company.



"It is our understanding that the test complies with FDA's guidance for distributing serology tests that identify antibodies," the company wrote on a question-and-answer page about the coronavirus test kits. With COVID-19 posing a public health emergency, the test kits are currently not required to go through the FDA's typical clearance or approval processes, nor do they require emergency-use authorization, the company said.

Henry Schein plans to make the test available for doctors offices, hospitals and other health care institutions.

Health care professionals can use the test results, along with a patient's medical history, symptoms, and results of other relevant testing, to make informed decisions about patient treatment and care.