Test Kit Includes:
- Test Cassette
- Dilution Buffer
- Disposable Pipette
- Alcohol Swabs
What is COVID19 and what is serologic testing?
COVID-19 is caused by the SARS-CoV-2 virus. The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally, including the United States. It likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). For the most up-to-date information on COVID19 please visit the CDC Coronavirus Disease 2019 (COVID-19) website: https://www.cdc.gov/COVID19.
The test will involve obtaining a drop of blood via finger prick, with a lancet. The blood sample will be applied to a test cassette, which will return a result that is visually interpreted. The results indicate if certain antibody types (IgG or IgM) are detected, or if the test is invalid and needs to be repeated. As for any test, the sensitivity (ability to detect antibodies when present) and specificity (antibody detected by the test represents the true presence of the antibody) are not 100%.
How are the test results interpreted?
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitrodiagnostics 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 revoked by FDA (after which the test may no longer be used).
Is there any risk?
The risks of the standard test finger include possible discomfort or other complications that can happen during sample collection or possible incorrect test result. The software program will require that you share information.