CDPH warns consumers against use of COVID-19 tests not approved by the U.S. Food and Drug Administration (FDA)
Most of the tests currently used to detect SARS-CoV-2, the virus that causes COVID-19 disease, by the State Public Health Laboratory, local public health laboratories, and licensed commercial laboratories are molecular polymerase chain reaction (PCR) tests. The FDA has recently authorized an antigen test that, like PCR and other molecular tests, uses a sample collected from a patient’s nose or throat with a swab or sputum specimen, and can indicate that the patient has active disease. FDA-authorized PCR testing is the most accurate testing currently available. Positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. Negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.
There are currently several FDA-approved COVID-19 serology tests available in the United States. Serology testing uses a blood sample to detect and measure the number of antibodies present in the blood when the body is responding to a specific infection like COVID-19, and may indicate that a person's body has developed antibodies against a particular virus. Serological tests can be used to track the spread of a disease, but they are not reliable for diagnostic purposes and are not approved for such use. For more information about unauthorized COVID-19 tests, visit the FDA website for an
update on serological tests.
California residents should understand that:
There is currently no Centers for Disease Control and Prevention guidance on how to interpret or take public health action in response to a positive or negative COVID-19 serology result.
They should check the
FDA website to determine if a company or physician that claims FDA approval or authorization for a serology test is actually approved.
Only a few COVID-19 serology test kits have been reviewed by the FDA or received Emergency Use Authorization.
Negative results do not rule out COVID-19 in a patient and results from serological testing should not be used as the sole basis to diagnose or exclude infection, or to inform infection status.
Please visit the California Testing Task Force website for more
guidance on serology testing (PDF).
Where can I get tested?
Please visit the
CDPH COVID-19 Updates webpage or the
California Testing Task Force webpage for continually updated information about COVID-19 testing or
contact your county health office. If you think you are sick, check the
Coronavirus.gov website for the latest information about COVID-19 prevention, symptoms, and answers to common questions.
Do I need a doctor's order to get tested?
California law (BPC section 1288) requires that a clinical or public health laboratory accept assignments for clinical laboratory tests only from persons licensed under the provisions of law relating to the healing arts as healthcare providers with a scope of practice that authorizes ordering clinical laboratory tests or their representatives. On May 12, 2020, the Director of the Department of Consumer Affairs issued a waiver authorizing licensed pharmacists to order tests and collect samples for SARS-CoV-2 testing for the duration of the COVID-19 emergency.
Five over-the-counter tests can be performed without an order (pregnancy, glucose level, cholesterol, fecal occult blood, and HIV), but all the tests for SARS-CoV-2 must be ordered by licensed medical personnel authorized to order such tests.
Physician or Practitioner Order for COVID-19 Tests issued by CMS states that CMS will not require an order from a treating practitioner as a condition of Medicare coverage of COVID-19 testing during the COVID-19 emergency.
However, this statement clarifies that
FDA requirements for a prescription and state requirements around ordering diagnostic tests still apply.
Where can I report a coronavirus scam?
Report coronavirus scams to the National Center for Disaster Fraud Hotline at 866-720-5721 or by email to
email@example.com, or report it on the
FBI tips website. If it is a cyber scam, submit your complaint through the
government cybercrime website. Criminals are exploiting COVID-19 through scams including selling fake cures, posing as legitimate organizations to obtain private information, activating malicious websites and apps to gain access to your devices, and seeking donations for illegitimate organizations. Also visit the
U. S. Department of Justice - Report COVID-19 Fraud website.
You can also submit reports about suspected fraudulent testing or therapy to the
FDA's Health Fraud Program or by email to
Where can I file a complaint concerning a laboratory?
Please visit the
Laboratory Field Services - Contact Us webpage for details on filing a complaint about a clinical laboratory. If you believe it is a cyber scam, submit your complaint through the
government cybercrime website.
What are the COVID-19 workplace safety rules for healthcare workers and/or non-healthcare workers?
Please visit the Cal/OSHA website:
Cal/OSHA Guidance on Requirements to Protect Workers from Coronavirus.