Henry Schein has announced the availability of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test, intended to be administered at the point of care. The test delivers results within 15 minutes from a pinprick with no instrumentation required.
Health care professionals can use the results of the test, along with a patient’s medical history, symptoms, and results of other relevant testing, to make informed decisions about patient treatment and care.
Henry Schein is working through multiple channels to distribute the tests in the United States as quickly as possible in response to the urgent need for rapid, accurate testing. The company anticipates having at least several hundred thousand tests available by March 30 and significantly increased availability beginning in April 2020.
The Standard Q COVID-19 test is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG antibodies associated with the 2019 novel coronavirus (SARS-CoV-2) in blood drawn with a pinprick.
Because serology tests measure antibodies, they can help assess the likelihood of past as well as present infection and are meant to be used as an aid to health-care professionals in diagnosing the mid- to later stages of the viral infection. Along with other information, such as the presence of symptoms, the tests may help health-care professionals assess whether individuals (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.
The Standard Q COVID-19 IgM/IgG Rapid Test is being made available under emergency guidance issued by the US Food and Drug Administration (FDA).
“Henry Schein is committed to providing health care professionals with quality products they can rely on to care for patients,” said Stanley M. Bergman, chairman of the board and chief executive officer of Henry Schein. “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.”
As the world’s largest distributor of health care solutions to office-based dental and medical professionals, Henry Schein is uniquely positioned to distribute the Standard Q COVID-19 test efficiently. Henry Schein plans to make the Standard Q COVID-19 test available for use by physician offices, hospitals, and other relevant health care institutions.
The distribution of the kit is part of Henry Schein’s continued efforts to address pandemic preparedness and response. Among other efforts, Henry Schein is in direct contact with the World Health Organization and other multilateral and domestic organizations as part of Henry Schein’s role as the private-sector lead of the Pandemic Supply Chain Network, a public-private partnership created in 2015 to improve the efficiency of the supply chain for personal protective equipment.
The Standard Q COVID-19 test is manufactured by SD Biosensor Inc., a global biodiagnostic company. SD BioSensor is represented by VelocityDX in the United States. Henry Schein intends to add other tests from VelocityDX and other suppliers specific to COVID-19, with the goal of offering a wide array of point-of-care tests for health care professionals.
A Q&A addressing the new test and providing additional information about it is available at henryschein.com/COVID19Statements.
For customers interested in more information about the Standard Q COVID-19 IgM/IgG Rapid Test, please contact Henry Schein at (844) 211-0140.
To learn more about what Henry Schein is doing to address this unprecedented situation and the actions the company is taking to get more product into the hands of those who need it most – health care workers – please visit henryschein.com/COVID19update.
Editor's note: This article is an edited version of a press release issued March 26, 2020, by Henry Schein. Press releases may be submitted to d[email protected] for review and posting consideration.