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.
Please use the page to learn more about POC testing and CLIA certificates.
The San Bernardino County Department of Public Health (SBCDPH) is offering free COVID-19 POC antigen tests to eligible facilities. Interested facilities must have a CLIA Certificate and access to the CalREDIE system for reporting positive results.
Facilities eligible to receive POC test kits include:
• Hospitals
• Cares associate with FQHC’s
• Skilled Nursing Facilities (SNFs)
• Long-term care facilities and nursing homes
• Community Health Centers
• Tribal communities
• Migrant Health Centers
• Health Care for the Homeless
• Health Centers for Residents of Public Housing, and Rural Health Clinics
Important FDA Expiration Date Information:
The FDA has extended the expiration dates for Professional CLIA-waived BinaxNow Antigen tests. Please see the chart on the right side of the page to view the latest expiration information.
Call the COVID-19 Antigen Testing Program at: (909) 531-0516 or contact us via email at sbcovid19testing@dph.sbcounty.gov for more information or questions.
| CDPH/CMS Point-of-Care Expiration Date Extension Information | FDA Point-of-Care Expiration Date Extension Information |
|---|---|
| On March 4, 2022, the California Department of Public Health (CDPH) authorized the use of OTC COVID-19 Antigen test kits beyond their FDA-authorized expiration date. Please see guidance here: Temporary Extension of At-Home Test Kit Expirations. This emergency extension is temporary and may be discontinued by CDPH at any time. To stay updated with the latest announcements, visit testing.covid19.ca.gov. | If you would like to see a list of the latest FDA Expiration Date Extensions, please see below: • BinaxNow • CareStart |
Available Point-of-Care (POC) Antigen Tests
- Complete, sign and return the Provider User Agreement form via email to SBCOVID19testing@dph.sbcounty.gov
- Once the completed Provider User Agreement form is received, you may submit a request for POC Antigen test kits using the electronic request: here
***Chrome or Edge preferred
Eligible facilities should prioritize testing individuals that are uninsured or communities with limited access to testing resources, as well as:
- Symptomatic or asymptomatic individuals in COVID-19 outbreaks
- Individuals returning to work, schools, or travel and testing again 3-5 days later
- For post exposure or response testing of individuals exposed to someone who tested positive for COVID-19
- For routine diagnostic screen testing (recommend at least twice weekly with antigen testing)
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