April 6, 2020
HHS Supports State, Territorial and Tribal Public Health Labs with COVID-19 Rapid Point-of-Care Test
The U.S. Department of Health and Human Services is purchasing the ID NOW COVID-19 rapid point-of-care test, developed by Abbott Diagnostics Scarborough Inc., for state, territorial and tribal public health labs. The ID NOW COVID-19 test is performed on the ID NOW device. This test allows for medical diagnostic testing at the time and place of patient care, provides COVID-19 results in under 13 minutes and expands the capacity for coronavirus testing for individuals exhibiting symptoms as well as for healthcare professionals and the first responder community. Additionally, this will save Personal Protective Equipment (PPE) and ensure our critical workforce is safe and able to support the response, as only gloves and a facemask are necessary to administer this rapid point-of-care test.
"Getting rapid tests to state, local and tribal public health departments will give them a new tool to protect key populations, such as healthcare workers, and slow the spread," said HHS Secretary Alex Azar. "Defeating the invisible enemy requires continuously expanding our testing abilities. President Trump's all-of-America approach to beating the coronavirus is bringing new tools like rapid tests to market all the time, and we will continue working across the government to get these tools to those who need them most on the frontlines."
HHS is providing these tests and devices to public health labs (PHLs) in every state and territory, and Washington, D.C. To ensure that remote and rural populations are also being reached, the Indian Health Service will receive tests and devices to distribute to selected IHS and tribal locations. Additionally, HHS is procuring ID NOW COVID-19 tests and devices for the Strategic National Stockpile (SNS).
Abbott is producing 50,000 ID NOW COVID-19 rapid point-of-care tests per day to supply the commercial market. The International Reagent Resource (IRR), operated by the Centers for Disease Control and Prevention, will procure additional tests each week to support requests from PHLs. The test devices will begin arriving at PHLs as early as Monday, April 6. Test resupply for the state health labs will be routed through the IRR.
"This type of rapid, point-of-care test is a critical component of our overall national strategy for testing. It is a special resource that we will prioritize for vulnerable patients whose treatment or isolation require a rapid determination of COVID-19 status, or for outbreak investigations where an immediate result is essential," said Assistant Secretary for Health ADM Brett P. Giroir, M.D.
On March 27, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Abbott Diagnostics Scarborough Inc. for their ID NOW COVID-19 diagnostic platform (device and consumable test materials) for detection of SARS-CoV-2 viral RNA in nasal, nasopharyngeal or throat swabs.
Information regarding EUA diagnostic tests, and associated components, is located on the FDA website here.