• Text Resize A A A
  • Print Print
  • Share Share on facebook Share on twitter Share

COVID-19 Rapid Point-Of-Care Test Distribution

The U.S. Department of Health and Human Services (HHS), in partnership with the Department of Defense (DOD), is providing rapid point-of-care tests to communities across the US in an effort to trace, contain, and combat the spread of COVID-19.

HHS is distributing 150 million rapid, Abbott BinaxNOW™ COVID-19 tests to expand strategic, evidence-based testing in the United States. 


What is the Abbott BinaxNOW™ COVID-19 Test?

The BinaxNOW™ COVID-19 test is a lateral flow test that detects the presence of protein antigens from SARS-CoV-2 in individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

This U.S. Food and Drug Administration (FDA)-authorized diagnostic test does not require any instrumentation to test the samples and instead determines a COVID-19 negative or positive result using a test card. This test has been authorized only for the detection of the nucleocapsid protein antigen from SARS-CoV-2, not for any other viruses or pathogens.


Distribution of Abbott BinaxNOW™ COVID-19 Test

HHS will distribute approximately 100 million tests to states and territories through the end of December of 2020. HHS has already begun distributing tests to nursing homes, assisted living facilities, home health and hospice agencies, Historically Black Colleges and Universities (HBCUs), the Indian Health Service, and States recovering from natural disasters.

States and territories will receive approximately 100 million tests through December 2020, distributed in proportion to their population.  Governors will determine the best use of tests for their states; suggested deployment includes use cases for which a low cost, rapid, easily administered test is uniquely able to fill state needs, such as opening of K-through-12 schools through testing of teachers, staff, and students, protecting first responders, supporting critical infrastructure, enhancing higher education programs, and other priorities the governors deem fit.

Distribution of tests are distributed based on the degree of community spread within the county where the home is located, and are intended to support screening of nursing home staff to meet CMS requirements.  Current distribution is based on the degree of positivity within counties:  Nursing homes in areas with greater than 10% positivity (red counties) and those in areas with 5-10% positivity (yellow counties) will be prioritized.

  • Red counties: test allocation for testing of all staff 2x/week. 
  • Yellow counties: test allocation for testing of 50% of staff 1x/week.

The distribution of BinaxNOWTM is in addition to the capabilities already provided to these facilities through the distribution of BD or Quidel point of care instruments, tests, and funding.

All assisted living facilities with a CLIA Certificate of Waiver will receive BinaxNOW tests.   Currently, there are approximately 5,000 assisted living facilities with such a Waiver.  Similar to nursing homes, distribution is based on the degree of positivity within counties:  assisted living in areas with greater than 10% positivity (red counties) and those in areas with 5-10% positivity (yellow counties) will be prioritized.

  • Red counties: test allocation for testing of all staff 2x/week. 
  • Yellow counties: test allocation for testing of 50% of staff 1x/week.

Distribution of tests will be sent to the largest 100+ home health and hospice agencies to then be distributed to locations within their agencies. Tests allocations will allow agencies to test staff once a week. This allocation will cover staff that visit over 1.8M patients.

Allotments of tests are based on the total number of faculty, staff, and students within the specific HBCU. Testing may be used for diagnosis in symptomatic individuals, contact tracing, baseline surveillance, or other needs as determined by the HBCU leadership. HHS has multiple lines of communication with HBCUs to support the development of individual strategies.

IHS received 300,000 tests that will be potentially distributed to eligible health programs that care for K-12 schoolchildren who attend Bureau of Indian Education-funded schools, students at tribal colleges and universities, or elders in senior living arrangements and other special needs populations by federal, tribal, and urban facilities that request them from the IHS National Service Supply Center. Allocations will be determined by IHS.


Training 

Abbott will contact public health officials at the state level and territories to provide guidance regarding training and review implementation resources. Each state has designated a single point of contact for Abbott to work with on training. Test site training will be provided through online tools and reinforced with optional, reoccurring webinars. Testing sites should work with state officials on specific needs related to specialized training or questions about the assay, including where distributions have occurred.


Reporting Requirements

All states and labs must report the results of the COVID-19 tests that they conduct to the appropriate federal, state, or local public health agencies.

Laboratories must report data for all testing completed, for each individual tested. This data must be reported within 24 hours of test completion, on a daily basis, to the appropriate state or local public health department, based on the individual’s residence. Testing sites must report all diagnostic test data in accordance with the HHS Lab Data Reporting Guidance for COVID-19 issued June 4, 2020 and were to meet these reporting requirements by August 1, 2020 including providing your facility name and CLIA number when reporting results.

For more information, visit the CDC page on Reporting Lab Data.


Shipping Schedule

BinaxNOW™ COVID-19 Ag Card diagnostic antigen tests began shipping the week of September 14, 2020 and will continue until all 150 million tests have been shipped. Supplies will be sent directly to each central distribution point or facility, and will arrive in a single shipment directly from the manufacturer.

For shipment issues or questions, email ARDxUSGovernmentSupport@abbott.com.

NAVICA™ Mobile APP

The NAVICA™ Mobile APP is a free smart phone application from Abbott designed to provide test results to the patient that can be used to demonstrate the individuals testing status. It allows the BinaxNOW™ test to be linked to the patient through a QR code. For more information, refer to the NAVICA™ Mobile APP on the Abbott website. Currently the NAVICA™ Mobile APP is only available in English.

The BinaxNOW™ test can be done without using the NAVICA™ mobile application, however the goal of the application is to provide the patient a way to safely record their test result for COVID-19 for future use, where applicable. The application does not report results to the state and local public health departments and is only designed to report testing status to the patient.


This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov. Content will be updated pending the outcome of the Section 508 review.

Content created by Assistant Secretary for Public Affairs (ASPA)
Content last reviewed on October 7, 2020