Skip Navigation LinksOver-The-Counter-Tests-LHJ-Guidance




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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


December 30, 2021


TO:
Local Health Jurisdictions

SUBJECT:
Guidance for use of Over-the-counter tests for Local Health Jurisdictions

Note: This Guidance is no longer in effect and is for historical purposes only. ​​​​​​​​



Over-the-counter COVID-19 tests (also known as self-tests) allow individuals to conveniently learn their COVID-19 status in the comfort of their own home at a time of their choosing.  Convenient testing with rapid results may allow individuals with COVID-19 to learn their status earlier in their infection course resulting in earlier isolation and limiting the spread of COVID-19. Testing is one layer in a multi-layered approach to preventing the spread of COVID-19.

What are COVID-19 over-the-counter self-tests?

Over-the-counter self-tests refer to tests that are purchased without a prescription and specimens are collected and completely processed by an individual anywhere outside of a healthcare or lab setting without the supervision of a trained professional. This is different than home collection kits in which specimens are collected at home, but then are sent to a laboratory for processing. Self-tests may use a nasal or a saliva specimen and can either be a molecular or an antigen-based test.  Users should refer to the CDPH Updated Testing Guidance for more information about the different test types and their uses.

Over-the-counter self-tests

  • Antigen self-tests identify the nucleocapsid protein in the SARS COV-2 virus.
  • Molecular self-tests detect a specific genetic segment of the SARS-CoV-2 virus.
  • Both antigen self-tests and molecular self-tests may have a slightly lower sensitivity (might not detect all infections) but have similarly high specificity (those who are not infected with SARS COV-2 do reliably test negative) compared to laboratory-based tests.
  • See FDA's list of In Vitro Diagnostics Emergency Use Authorizations external icon for more information about the performance of specific authorized tests.

Who can use COVID-19 self-tests?

  • Any individual can use self-tests.  They should be conducted in a manner consistent with the manufacturer's instructions.
    • Note that each individual test, however, is approved only for specific ages. Parents may be required to supervise collection of specimens for their children below certain ages and that age varies based on the test used. Individuals should be directed to the individual self-test instructions provided with the test. See FDA's list of In Vitro Diagnostics Emergency Use Authorizations external icon for more information about the age requirements of specific authorized tests.
  • Self-tests can be used regardless of vaccination status and are just as effective in people that are vaccinated as in those that are not vaccinated.
  • Recommended testing scenarios for antigen and molecular tests can be reviewed in the CDPH test guidance.
  • CDC guidance should be used to meet international travel requirements into the US. Please refer to CDC guidance to learn what type of tests can be used to fulfill travel requirements into the US.

In workplace settings (including healthcare and high-risk congregate settings):

In workplaces, employers are subject to the Cal/OSHA COVID-19 Prevention Non-Emergency Regulations​​​ or in some workplaces the Cal/OSHA Aerosol Transmissible Diseases Standard, and should consult those regulations for additional applicable requirements.

Can self-tests be used to shorten quarantine for unvaccinated individuals that are in close contact with someone with COVID-19? 

  • Local health jurisdictions may be more restrictive in allowing options for shortened quarantine, based on local circumstances, resources, and exposure settings.

What are best practices for verification of self-test results?

The following are recommended methods to verify unsupervised or unobserved self-test results.  The practices listed below should strongly be considered in any context in which tests are being performed at the request of another entity, such as a school.

  • Use a digital (app-based) platform for test verification, which often includes scanning barcodes; these are available for certain brands of self-tests.
  • Write the name and date on the test card results and send a picture of the card to the requesting entity.
  • Create an attestation form and require signature declaring that the test specimen was obtained from the individual represented on the form, include the date the specimen was collected, and that the test was processed according to the instructions provided.

Individual reporting of self-test results 

  • Individuals should report their test result according to the instructions recommended by the test.
  • Some home tests have automatic reporting, others require the individual who tested to report their results through a phone application.
  • If the test does not provide electronic reporting, positive test results should be shared with their healthcare provider in order to receive appropriate medical care.

Interpreting Results

  • The individual should follow manufacturer's instructions for repeat testing when applicable. 
  • If a self-test is positive, regardless of presence of symptoms the individual should be presumed to have COVID-19 and should be instructed to undergo isolation and monitor symptoms per CDPH Isolation Instructions. The individual should inform their health provider regarding the results for guidance on management and the healthcare provider or individual may consider obtaining confirmatory molecular testing. Please see CDPH Testing Guidance for recommendations on when to conduct confirmatory laboratory molecular testing.
  • Healthcare providers should use symptoms, exposure history, travel, vaccination status, behavior and community transmission rates to determine pre-test probability of infection to guide the need for further testing and clinical management.

How should Local Health Departments treat positive self-test results?

  • Local health departments should assess persons reported with positive tests done in non-CLIA supervised settings as suspected positives. Individuals should isolate immediately and refer to the CDPH Isolation and Quarantine Guidance for recommendations.  

Reporting Results to State and Local Health Jurisdictions

  • Cases reported with self-tests results are classified according to the Council of State and Territorial Epidemiologists 2021 standardized COVID-19 surveillance case definition and as they are performed without trained supervision are considered supportive laboratory evidence; persons with a positive self-test should be considered a suspect case for surveillance purposes.
  • Testing done in non-CLIA supervised settings are not required to be reported to public health agencies.  If reported, these data should be sequestered and not used for case counting. For example, self-tests should not be entered in to "laboratory info" tab in the nCOV-2019 disease condition in CalREDIE, but rather in the "Notes/Remarks" section.
    • Non-CLIA supervised settings include self-testing and testing at locations (e.g., workplaces) that have not undergone training required by CLIA for CLIA waived testing. 
    • Persons with positive test results should:
      • Self-isolate
      • Contact their health care provider for medical advice
    • Results from non-CLIA supervised settings are subject to misreading and may have lower accuracy.

Reporting for Self-Administered Tests under Lab or Healthcare professional oversight

  • Self-tests performed with CLIA oversight, including tests reported by CLIA-certified laboratories via electronic laboratory reporting and those proctored by healthcare providers or testing sites, are considered presumptive (antigen) or confirmatory (molecular) laboratory evidence of COVID-19.  These test results must be reported to public health agencies.  Persons with positive tests done in a setting supervised by staff trained under CLIA requirements and will be classified as probable or confirmed cases based on the type of testing (antigen or molecular) completed.

* If a self-test kit as described above is used at school/other setting and the test is administered by another person (except if parent/guardian) then the regulatory requirements of professional kits need to be followed:

  • Requires CLIA-waiver and ordering MD
  • Reporting required