Information for Providers Requesting Abbott BinaxNOW™ Antigen Tests
Minnesota was notified it will get Abbott BinaxNOW™ COVID-19 Ag Card tests directly from the federal government. These tests will also go directly from the federal government to long-term care and assisted living settings.
The antigen test, which recently received emergency use authorization from the Food and Drug Administration (BinaxNOW™ COVID-19 Ag Card Letter of Authorization [PDF]), does not require instrumentation. It is for use with people who have symptoms and will deliver COVID-19 test results in 15 minutes or less.
As noted in the emergency use authorization, the BinaxNOW™ test must: be ordered by a health care provider; administered in a facility with a clinical laboratory improvement amendments (CLIA) certificate or a CLIA certificate of waiver; and be performed by a trained CLIA-certified laboratory staff member. These laboratories must also comply with MDH reporting requirements for test results.
Please read MDH guidance on using the test and the requirements for providers requesting the test, including priority populations:
- BinaxNOW™ Description and Provider Instructions to Distribute to Priority Populations (PDF)
The guidance describes the conditions for receiving and using the test cards and is effective as of Nov. 19, 2020. The guidance may be updated as scientific data and needs evolve.
Resources from Abbott:
For questions about the BinaxNOW™ Ag Card for COVID-19 antigen testing or NAVICA™, a new mobile app that Abbott designed to pair with the test, contact the Abbott Technical Services Team:
- Phone: 800-257-9525
Mon - Fri, 7 a.m. - 7 p.m.
- Email: firstname.lastname@example.org
BinaxNOW™ COVID-19 Ag CARD (PDF)
To request a biweekly supply of the tests:
- Review BinaxNOW™ Description and Provider Instructions to Distribute to Priority Populations (PDF) on use and requirements for entities receiving the test.
- Submit an online form: Abbott BinaxNOW Test Request Form
Demand may exceed supply, in which case MDH will prioritize entities serving priority populations and serving geographic areas:
- With high positivity rates
- Where testing access is limited
- Where a large number of populations are disproportionately at risk
Questions? Email: email@example.com.