COVID-19 Point-of-Care (POC) Antigen Testing
COVID-19 Point-of-Care (POC) antigen tests offer a rapid and reliable solution for COVID-19 testing in settings where multiple people may need to test. This type of antigen test is performed by someone other than the individual being tested, or the results of the test are interpreted by someone other than the individual being tested. COVID-19 POC antigen tests are Clinical Laboratory Improvement Amendment (CLIA) waived tests. This means that they have been determined by the CDC or FDA to be a simple test with low risk for error. Facilities administering COVID-19 POC antigen tests must have a CLIA Certificate.
San Bernardino County is no longer allocating and distributing free Point-of-Care test kits. Facilities interested in purchasing Point-of-Care test kits directly from the manufacturer, please visit the manufactures websites for more information:
• BinaxNow Abbott
• CareStart Intrivo
• Status lifeSign
| FDA Point-of-Care Expiration Date Extension Information |
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| If you would like to see a list of the latest FDA Expiration Date Extensions, please see below: • BinaxNow™ • CareStart™ • Status™ |
Available Point-of-Care (POC) Antigen Tests
According to the CDC, Point-of-Care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested and can be performed in a variety of settings. Rapid tests used in point-of-care settings can be NAAT, antigen, or antibody tests.
These tests can be used to diagnose current or detect past SARS-CoV-2 also known as COVID-19 infections in various point-of-care settings, including but not limited to:
- Physician offices
- Urgent care facilities
- Pharmacies
- School health clinics
- Long-term care facilities and nursing homes
- Temporary locations, such as drive-through sites managed by local organizations
The COVID-19 POC Antigen test kits are CLIA waived tests and must be used by facilities that have a Clinical Laboratory Improvement Amendments (CLIA) Certificate.
The California Department of Public Health (CDPH) requires Laboratory or testing sites using COVID-19 Point-of-Care (POC) Antigen tests to report both positive and non-positive antigen test results through the California Reportable Disease Information Exchange (CalREDIE) Electronic Laboratory Reporting (ELR) system.
NOTE: Patients’ race and ethnicity must be reported for all COVID-19 test results.
Per the Laboratory Field Services, other reporting systems may be acceptable if your facility does not have access to CalREDIE such as:
- The National Healthcare Safety Network (NHSN) point-of-care test reporting tool (For Long-Term Care Facilities (LTCFs) and Skilled Nursing Facilities ONLY)
- The Navica app for Binax tests
- The CDC’s Simple Report platform
For more information, please visit their website at: CDPH Laboratory Field Services
| Reporting positive and non-positive results |
| California Department of Public Health reporting guidelines |
Types of CLIA Certificates accepted for Point-of-Care (POC) testing.
To obtain a CLIA Certificate:
- Visit the CMS CLIA website for information
- Fill out the application Form CMS-116
- Send completed application to your local State Agency
- There is a CLIA certificate waiver fee from the State Agency