COVID-19: Testing Information

Home COVID Test Updates

Expiration Date Extensions
Many COVID tests indicated for at home use have had their expiration dates extended. Check the kits you have on your shelves and make sure you let patients know this when you sell or dispense these tests!
- iHealth
- Flowflex
- Abbot BinaxNow

Recalls
- Ellume - increased risk of false positives

FDA Emergency Use Authorization (EUA)

This page has the most recent FDA information regarding COVID-EUA authorized testing. On this page, you will find the Test Kit Manufacturers and Commercial Laboratories Table. This table includes all of the tests that have received an FDA EUA authorization. Information provided on the page for each test includes manufacturer, the letter of authorization, technology, authorized settings, authorization documents, and any other documents that are available regarding the specific tests.

Important sections of the table to make sure and review for tests you are interested in are:

1. Diagnostic letters - provide you product details that you will need to know before administering the tests.
2. Authorized settings - informs you if the test has been authorized for high complexity, high and moderate complexity or CLIA waived labs.
3. Authorization documents – provides links to fact sheets for healthcare providers and patients, product inserts, and EUA summaries, if available.

KDHE Clinical Laboratory Improvement Amendments (CLIA) Laboratories

KDHE CLIA Laboratory Certification
6810 SE Dwight Street
Topeka, KS 66620
(785) 296-3811
FAX: (785) 559-5207
Email: kdhe.clia2@ks.gov

This contact information should be used to submit new CLIA-waived sites as well as send in updates if you add a new test to your testing capabilities. Updates should include the name of your practice, the name and manufacturer of the test, and the approximate number of tests per year your site expects to complete.