LI Firm To Ship 15-Minute Coronavirus Test Kits Nationwide

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.

The test is a rapid immunochromatography assessment designed to detect the specific antibodies associated with the new coronavirus in blood drawn with a pinprick. Serology tests measure antibodies and can help assess the likelihood of past and present infection. They're meant to help health care professionals diagnose the mid to late stages of COVID-19. Along with other information, such as the presence of symptoms, the tests may help health care professionals assess whether people — including health care workers — have recovered from the virus. Follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.

"Henry Schein is committed to providing health care professionals with quality products they can rely on to care for patients," Stanley M. Bergman, chairman of the board and chief executive officer of Henry Schein said in a news release. "Henry Schein has played a key role in providing point-of-care testing to health care professionals, and is now responding to the urgent need for wide availability of rapid point-of-care testing for COVID-19. This pandemic is an unprecedented situation, and making rapid diagnostic tools available to health care professionals is critical for detecting and mitigating the spread of the coronavirus."

The kit's distribution is part of the company's continued efforts to address pandemic preparedness and response, it said. Henry Schein is in contact with the World Health Organization and other organizations.

Henry Schein is a solutions company for health care professionals powered by a network of people and technology that spans more than 19,000 "Team Schein" members worldwide, according to the company's press release. The Melville company has operations or affiliates in 31 countries.

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