Coronavirus Testing Basics
You’ve probably heard a lot about coronavirus testing recently. If you think you have coronavirus disease 2019 (COVID-19) and need a test, contact your health care provider immediately. The FDA has been working around the clock to increase the availability of critical medical products, including tests for the coronavirus, to fight the COVID-19 pandemic. Learn more about the different types of tests and the steps involved.
Home COVID Test Updates
Expiration Date Extensions
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:
KDHE Clinical Laboratory Improvement Amendments (CLIA) Laboratories
KDHE CLIA Laboratory Certification
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.
Federal CLIA Application Form CMS-116 (must be filled out to request a CLIA Certificate of Waiver)
CMS CLIA How to obtain a CLIA Certificate of Waiver instruction booklet
CLIA Ready? Set? Test? Waived testing handbook
Ready Set Test checklist for CLIA waived sites
NCPA COVID-19 test billing information
HRSA Uninsured Billing information