The Food and Drug Administration issued a statement on September 23 granting emergency use authorization of the Assure COVID-19 IgG/IgM Rapid Test Device, the first antibody point-of-care test for COVID-19. Point-of-care testing is testing performed outside of a lab, close to the patient. It could be in a doctor’s office, hospital room, or anywhere the patient is.
The public is used to seeing images of COVID-19 testing using the long swabs that are inserted through the nose. While these tests are in common use, researchers are trying to develop more effective and sensitive tests using antibodies. If someone is infected with SARS-CoV-2, the virus that causes COVID-19, their body will produce antibodies that circulate in the blood.
The statement said: “The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that EUA is being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.”
According to the FDA, this test is the only one that has been authorized as a serology (blood) point-of-care test for COVID-19 and is only available by prescription. Other serology tests require blood samples that are processed through a laboratory.