On August 27, 2020, the federal government announced that it has partnered with Abbott Laboratories to produce rapid point-of-care COVID-19 tests and has purchased 150 million tests for distribution to certain healthcare providers across the country. This announcement followed the Food and Drug Administration (FDA) emergency use authorization for this new type of COVID-19 antigen test, where test results can be read directly from the testing card.
The U.S. Department of Health and Human Services (HHS) announced plans to distribute Abbott BinaxNOW COVID-19 tests to eligible home health and hospital providers based on certain testing prioritization criteria. This initiative follows a similar program by HHS involving widespread distribution of rapid COVID-19 testing machines and tests to nursing homes and assisted living facilities, as well as other provider types across the country.
On September 25, 2020, HHS hosted a webinar to discuss the initiative and Abbott BinaxNOW tests. A recorded version of the webinar should be released soon. During the webinar, the presenters confirmed that the test kits will be provided free of charge to home health and hospice providers, and stressed that the test should be used to test staff, not patients. HHS anticipates providing weekly allocations of test kits with distribution coordinated through local Home Health and Hospice Associations. Providers located in counties with a higher prevalence of COVID-19 cases will be prioritized. The presenters also confirmed that providers must hold a CLIA Certificate of Waiver in order to utilize the BinaxNOW tests, and providers that already hold CLIA Certificates of Waiver will be prioritized for distribution. Providers’ weekly allocations may vary based on changing needs.
The BinaxNOW test is a nasal swab test, with 97.1% performance positive agreement and 98.5% negative percent agreement. Each test kit includes 40 test cards and nasal swab kits. Unlike other rapid result tests, no specialized equipment is needed to read the results. The point-of-care BinaxNOW test results can be read in about 15 minutes.