On Mar. 26, 2020, Henry Schein 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 delivered 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, the company said.

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 U.S. Food and Drug Administration (FDA).