Attn: Assisted Living Providers
September 18th Webinar re: U.S. Department of Health and Human Services (HHS) rapid COVID-19 tests for Assisted Living Facilities
Over the last several days, Assisted Living Facilities have contacted the Department regarding the U.S. Department of Health and Human Services (HHS) rapid COVID-19 tests that will be dispersed to assisted living facilities. As part of an historic initiative led by the HHS and the Department of and Defense (DOD), the Administration awarded a contract for $760 million to Abbott for delivery of 150 million rapid, Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests to expand strategic, evidence-based testing in the United States.
Webinar
Tomorrow, September 18, 2020, HHS and Abbott are hosting a webinar from 11 a.m.-12 p.m. to discuss the process. All Assisted Living Facilities are encouraged to register. Register for webinar.
FDA-Authorized Intended Use
The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Testing is limited to laboratories certified under the CLIA, 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate for Provider-performed Microscopy procedures, Certificate of Compliance, or Certificate of Accreditation.
Shipping Schedule
Authorized BinaxNOW COVID-19 Ag Card diagnostic antigen tests begin shipping the week of September 14, 2020, and will continue through December 20, 2020. Supplies will be sent directly to each facility, and will arrive in a single shipment directly from the manufacturer.
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