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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.


How are Abbott BinaxNOW™ COVID-19 test being distributed?

Distribution of rapid tests to states and territories

HHS is distributing 150 million Abbott BinaxNOW diagnostic tests to states and territories as quickly as possible. This effort ensures that governors will not have to compete for the initial BinaxNOW shipments, or waste precious time to set up purchasing contracts.

State Total Number of Tests Allocated
Alabama 1,470,000
Alaska 220,000
American Samoa 10,000
Arizona 2,190,000
Arkansas 900,000
California 11,900,000
Colorado 1,730,000
Connecticut 1,070,000
Delaware 290,000
District of Columbia 210,000
Federated States of Micronesia 30,000
Florida 6,460,000
Georgia 3,190,000
Guam 50,000
Hawaii 420,000
Idaho 530,000
Illinois 3,810,000
Indiana 2,020,000
Iowa 950,000
Kansas 870,000
Kentucky 1,340,000
Louisiana 1,400,000
Maine 400,000
Marshall Islands 10,000
Maryland 1,820,000
Massachusetts 2,070,000
Michigan 3,000,000
Minnesota 1,690,000
Mississippi 890,000
Missouri 1,840,000
Montana 320,000
Nebraska 580,000
Nevada 920,000
New Hampshire 400,000
New Jersey 2,670,000
New Mexico 630,000
New York 5,850,000
North Carolina 3,150,000
North Dakota 220,000
Northern Mariana Islands 10,000
Ohio 3,520,000
Oklahoma 1,190,000
Oregon 1,270,000
Palau 5,000
Pennsylvania 3,850,000
Puerto Rico 960,000
Rhode Island 310,000
South Carolina 1,550,000
South Dakota 260,000
Tennessee 2,050,000
Texas 8,730,000
U.S. Minor Outlying Islands 0
U.S. Virgin Islands 30,000
Utah 960,000
Vermont 180,000
Virginia 2,570,000
Washington 2,290,000
West Virginia 530,000
Wisconsin 1,750,000
Wyoming 170,000
Totals 99,705,000

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.

States and territories will receive tests in proportion to their population. Governors will determine the best use of tests for their states. Below are highlights of how states plan to use these rapid, easily administered tests to fill their unique needs.

  • Alaska plans to distribute tests to marine trade schools, oil workers camp, and school districts. Long term care facilities may also request rapid tests from the state as needed.
  • Arizona has deployed tests to county health departments for their distribution (based on population size of each jurisdiction) and a small portion of tests have been dedicated to state agencies and institutes of higher education.
  • Arkansas has dedicated some tests for Department of Corrections' visitors, residents, and staff and also to state Department of Health Services' staff. Over half of tests will be deployed to K-12 schools for weekly screening of staff; and other tests will be held in reserve for healthcare workers and other vulnerable populations.
  • California will distribute tests based primarily on county population, and additional tests are being distributed to counties with high case rates.
  • Colorado will partner with pharmacies to facilitate access to in person testing for individuals. State allocations will also be sent to youth correction facilities and local public health agencies to test their homeless population.
  • The District of Columbia will distribute tests to long term care facilities, group homes, HBCUs, skilled nursing facilities, and Federal facilities.
  • Hawaii will dedicate 10% of their BinaxNOW test allotment for virus outbreaks, 35% of tests for congregate living situations, 50% of tests for education, and 5% for travel.
  • Idaho has provided tests to seven local public health districts to assist with school openings. They plan to send tests to hospitals for disadvantaged communities and then to Emergency Medical Systems in rural areas of the state.
  • Illinois has provided the City of Chicago 42,000 tests to combat clusters of outbreaks. Long term care facilities were directly sent 198,000 tests and the state will also deploy tests to be used in local schools.
  • Indiana has sent 243,000 tests directly to long term care facilities and plan to deploy tests to K-12 schools to tests students along with strike teams to support school events. The state will also prioritize the Department of Corrections and Clinical Laboratory Improvement Amendment-waived sites in orange and red counties.
  • Iowa will deploy tests to fifty-four K-12 sites to support school testing and also to four hundred eighty-three long term care facilities.
  • Kentucky has shipped tests to public universities and local health departments to support K-12 schools, universities, and homeless shelter operations. They also plan to use the tests for vulnerable populations and correctional institutions.
  • Massachusetts plans to use the tests to support K-12 schools. The Massachusetts Department of Public Health is also working to conduct side-by-side testing utilizing a PCR assay and these tests to help inform their future deployment of tests.
  • Michigan has sent 45,000 tests to their long term care facilities, 12,000 to their Department of Corrections, 80,000 to psychiatric hospitals and also to the National Guard for training purposes.
  • Minnesota has shipped 400,000 BinaxNOW tests to long term care facilities and plan to pilot the use of the tests in K-12 population through pediatric offices. Institutes of higher education will have tests in their clinics and will run molecular test at the same time. The State is also considering use with first responders and at Opioid Treatment Centers.
  • Mississippi plans to provide tests to sheltering operations in response to hurricanes and to state Veterans Affairs homes not licensed by the Centers for Medicare and Medicaid Services to administer tests. Mississippi is also supporting schools through Community Health Center programs and with mobile units and will provide tests to long term care facilities that are not already receiving tests directly from HHS.
  • Missouri plans to deploy 60% of their test allotment to support K-12 school testing programs, 30% to institutes of higher education and 10% of tests are likely to be retained for state priorities.
  • Montana plans to send 2/3 of tests to public education and institutes of higher education, 1/3 to community health centers and large medical facilities, and a lesser portion to state correctional facilities and county detention facilities.
  • Nebraska has sent sixty percent of their first shipment to nursing homes, and shipments to alternate sites are on hold pending a study being conducted by the state public health lab.
  • Nevada plans to distribute the tests as follows: 15% to the Department of Corrections, 50% to K-12 schools, 15% to skilled nursing facilities and assisted living facilities that have not received direct shipments of tests from HHS. The remaining 20% will be sent to Community and Tribal Health Clinics.
  • New York will use the tests for outbreak response. Local health departments will submit their plans for point of care testing to the state and have been asked to prioritize vulnerable and at-risk populations.
  • North Carolina are sending tests to counties with >5% positivity rate and allowing their local health departments to determine where tests should be sent. The state is recommending a focus on local schools, outbreaks, and high-risk congregate settings.
  • North Dakota plans to send tests to long term care facilities, opioid treatment programs, and to assist with local school opening.
  • Ohio has distributed 175,000 to institutions of higher education for the testing of asymptomatic individuals.
  • Oregon has reached out to seven tribes and contacted counties experiencing wildfires about using the tests. Fifty thousand tests will be distributed to long term care facilities and the state is working with individual counties to incorporate the rapid tests into their testing programs.
  • Pennsylvania will first send tests to long term care facilities, skilled nursing facilities and then correctional facilities. Pennsylvania also plans to incorporate tests into Alcohol/Behavioral Health Facilities and will extend availability to universities.
  • South Dakota will send tests directly to long term care facilities. Approximately 17,000 will be sent to K-12 schools and some will also be deployed to assist Tribes with their COVID-19 testing.
  • Tennessee will deploy tests for use by first responders and are working out details to provide tests to county homes, VA homes, correctional facilities and for K-12 school testing.
  • Utah sent tests to thirteen local health departments, and will distribute tests to universities, and then to vulnerable and homeless sheltering populations.
  • Virginia has shared tests with mental health centers and plans to roll out tests to higher education, K-12, corrections facilities, and hospice centers. A small number of tests will be used for validation studies overseen by the state.
  • Washington plans to deploy tests to hospitals and Federally-funded critical health care facilities, followed by skilled nursing facilities, correctional facilities, and residential treatment programs.
  • West Virginia plans to use the tests for schools and healthcare workforce.
  • Wisconsin has provided tests to long term care facilities and approximately 208,000 to hospitals.

Distribution of rapid tests to targeted entities

HHS has also distributed 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.

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. Long-term care facilities and nursing homes must have a CLIA Certificate of Waiver and be Federally-certified by CMS as a Medicare Skilled Nursing Facility (SNF) and/or Medicaid Nursing Facility (NF). 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 all staff 1x/week.
  • Nursing homes below 5% positivity (green counties) will not receive tests through the federal distribution.

The federal distribution of BinaxNOW™ 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.  Nursing homes should also use their existing procurement processes to ensure adequate testing for residents based on current guidelines.

All assisted living facilities with a CLIA Certificate of Waiver with the appropriate type of laboratory designation, 04 - Assisted Living Facility, as listed on Form CMS-116, will receive BinaxNOW™ tests. As with nursing homes, distribution is based on the degree of positivity within counties: assisted living facilities 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 all staff 1x/week.
  • Assisted living facilities below 5% positivity (green counties) will not be prioritized to receive tests.

The distribution of BinaxNOW™ tests to assisted living facilities is intended to supplement existing testing capabilities available to those facilities.  Assisted living facilities should use their existing procurement processes to ensure adequate testing for residents based on current guidelines.

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 diagnostic test results for COVID-19 must be reported to the appropriate federal, state, or local public health agencies.

All data for testing completed, for each individual tested, must be reported. 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. Please visit the CDC website for more information about data reporting requirements.


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 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 Health (ASH)
Content last reviewed on November 30, 2020