How are the tests paid for?
The federal COVID-19 public health emergency ends on May 11, 2023 and California laws extend these requirements for 6 months through November 11, 2023. Health plans regulated by the California Department of Managed Health Care (DMHC) must cover the COVID-19 tests, vaccines, and treatments with no health plan prior authorization or enrollee cost-sharing.
California insurance companies and health plans are required to cover 8 free over-the-counter at-home tests per covered individual per month.
Contact your insurance company for reimbursement procedure.
For more questions regarding insurance coverage on the cost of at-home COVID-19 tests, please visit:
https://www.chhs.ca.gov/end-
https://www.dmhc.ca.gov/
How does the Fastep COVID-19 Antigen Home Test work?
The Fastep COVID-19 Antigen Home Test is an antigen test. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). The Fastep COVID-19 Antigen Home Test is able to detect small parts of the SARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions.
For a demonstration on how the test works, watch the instructional video here.
Will the Fastep COVID-19 Antigen Home Test detect COVID-19 variants?
Fastep has completed testing on several heat inactivated variant strains and the Fastep COVID-19 Antigen Home Test was able to detect mutations including Delta and Omicron variants. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.
How accurate is the Fastep COVID-19 Antigen Home Test?
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at fastep.azure.bio.
Is this Fastep COVID-19 Antigen Home Test FDA approved or cleared?
No. This test has received Emergency Use Authorization (EUA) from the FDA but is not yet approved or cleared by the United States FDA. FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used).
What is the age range for the test?
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older.
Do I always need to perform two tests?
If you have COVID-19 symptoms and are within the first 7 days of symptom onset, you can use one single test of the Fastep COVID-19 Antigen Home Test. You may also choose to perform two tests if you wish. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection.
If you do not have COVID-19 symptoms or have been having symptoms for more than 7 days, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests.
Is the Fastep COVID-19 Antigen Home Test reusable?
No. All the components of Fastep COVID-19 Antigen Home Test are not reusable and can only be used once.
Will the test work if I don't have symptoms?
Yes. If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests.