The Food and Drug Administration (FDA) has reminded the public that the purchase of rapid antibody-based test kits for COVID-19 requires a licensed doctor’s prescription from an accredited hospital based on its Advisory 2020-498. Online sale is also prohibited. Subsequently, the said test kits must be administered by a trained health professional and interpretation of the result must be guided by a physician.
The FDA is urging the public to report incidents regarding the improper dispensing and use of COVID-19 Rapid Antibody Test Kits by sending email of detailed information as possible about the source, name of product, importer/distributor and other necessary details to email@example.com.
Read copy of FDA Advisory 2020-498 below.
Meanwhile, below is the list of FDA-approved COVID-19 rapid antibody test kits as of April 24, 2020.
Below is the updated list of FDA-approved COVID-19 test kits for commercial use as of April 24, 2020.