BinaxNOW COVID-19 Testing Kits

A number of assisted living providers in North Carolina and throughout the United States have recently received free BinaxNOW COVID-19 testing kits in the mail. These kits were purchased by by the US Department of Health and Human Services (US DHHS) and sent out to assisted living providers that currently have a CLIA Certificate of Waiver (CLIA is the Federal Clinical Laboratory Improvement Amendments law). CLIA Waivers have been in place for years and allow health care providers to conduct basic laboratory testing onsite such as blood glucose testing and other tests without having to go through the process of becoming a CLIA certified laboratory. Since many assisted living providers already have CLIA Waivers, the US DHHS decided to send the BinaxNOW COVID-18 testing kits to these providers including approximately 600 providers in North Carolina.

For assisted living providers without CLIA waivers that would like to obtain a waiver so they might be eligible to receive the BinaxNOW COVID-19 testing kits free of charge, the Federal Centers for Medicare and Medicaid Services (CMS) is accepting applications. The links below contain information regarding how to apply for and obtain a CLIA Waiver. In addition, providers may also want to partner with a long term care pharmacy to obtain a waiver.
 

In the past week, NCSLA has received calls from providers stating they are not sure what to do with the BinaxNOW testing kits, i.e. use them for staff, residents, visitors, etc. Unfortunately, there was not very much guidance provided with the kits other than basic instructions no how to use them. NCSLA contacted the NC Division of Public Health for guidance regarding the BinaxNOW testing kits and they referred us to the Centers for Disease Control website (Click Here) and recommended using the kits for testing facility health care personnel (HCP) in two specific situations:

  1. Testing HCP with signs or symptoms consistent with COVID-19
  2. Testing asymptomatic HCP with known or suspected exposure to someone with COVID-19.

The resources at the following link (Click Here) are designed to provide the training necessary to successfully test individuals using the BinaxNOW COVID-19 testing kits. The BinaxNOW™ COVID-19 Ag Card test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*

For questions regarding using the BinaxNOW COVID-19 testing kits, you can contact Abbott Monday-Friday 8am-8pm at 800-257-9525 or ts.scr@abbott.com.