15-Minute Coronavirus Test Approved
A new coronavirus test delivers results within just 15 minutes from a pinprick with no instrumentation required and is intended to be administered at the point-of-care.
Henry Schein, Inc. announced on March 26, 2020, the availability of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test.
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 novel coronavirus (SARS-CoV-2) in blood drawn with a pinprick.
Healthcare professionals can use the results of the test, along with a patient’s medical history, symptoms, and results of another 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 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).
The Company anticipates having at least several hundred thousand tests available by March 30th and significantly increased availability beginning in April 2020.
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 test is manufactured by SD Biosensor, Inc., a global bio-diagnostic 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 the new coronavirus test is available here.
COVID-19 disease testing, vaccine, and medication development news is published by Precision Vaccinations.