COVID Clinic may offer multiple types of testing dependent upon location and availability. Please carefully review the information below concerning the types of testing that may be available. If you have any questions concerning any of the information provided, please contact COVID Clinic at info@covidclinic.org.
Informed Consent for Antigen Testing
Consent for Sofia SARS Antigen FIA Test.
The Sofia SARS Antigen FIA test is used to test for the presence of the proteins from the virus that causes COVID-19 in respiratory specimens, such as a nasal swab. The tip of a cotton swab is inserted into one nostril. The swab is rotated in a circle around the entire inside edge of the nostril at least three times. You may experience some discomfort during the collection process. There is a small risk of minor nose bleeding. You may also experience a temporary runny nose or brief changes in taste. Test results are typically available within 60 minutes.
The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (for example, a minor risk of nose bleeding); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.
If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.
By signing below, you understand that:
– This test has not been Food and Drug Administration (FDA) cleared or approved;
– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;
– This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
– The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
COVID Clinic makes no representations as to whether or not the testing services you receive will be reimbursable by your insurance provider.
Consent for Roche cobas SARS-CoV-2 (PCR Nasal Swab)
The nasal swab tests for the presence of COVID-19. The swab enters through the nose and is pushed to the back of your throat, just above the nasopharynx. The swab is then rooted to collect viral specimens. Upon obtaining the sample swab, it will be sent to an independent laboratory for testing. Results are typically available within 2 to 3 days and will be communicated to you.
The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (for example, a minor risk of nose bleeding or a runny nose); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.
Testing specimens using this test are collected by COVID Clinic and sent to an independent laboratory for testing. These laboratories may bill you directly for their services.
If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.
By signing below, you understand that:
– This test has not been Food and Drug Administration (FDA) cleared or approved;
– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;
– This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and
– The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
COVID Clinic makes no representations as to whether or not the testing services you receive from COVID Clinic or any third party laboratory will be reimbursable by your insurance provider.
Informed Consent for Antibody Testing
Consent for Antibody Test using Roche Elecsys Anti-SARS-CoV-2 test
The Roche Elecsys Anti-SARS-CoV-2 test measures the Igm and IgG “immunoglobin” or “antibody” in an individual’s blood for COVID. A sample of blood is obtained by venipuncture to perform this test. Venipuncture is the puncture of a vein to withdraw a blood sample. Upon obtaining the blood sample, it will be sent to an independent laboratory for testing. Results are typically available within 3 days and will be communicated to you.
The possible risks of this test include (i) potential discomfort or other complications that can happen during specimen collection (such as bruising or infection); and (ii) possible incorrect test result. Potential benefits of this test include: (y) the results, along with other information, can help your healthcare provider make informed recommendations about your care; and (ii) the results may help limit the spread of COVID-19 to your family and others in your community.
Testing specimens using this test are collected by COVID Clinic and sent to an independent laboratory for testing. These laboratories may bill you directly for their services.
If you receive a positive test result for COVID-19, you understand that COVID Clinic is required to report this to various government agencies, including the local health department.
By signing below, you understand that:
– This test has not been Food and Drug Administration (FDA) cleared or approved;
– This test has been authorized by FDA under an Emergency Use Authorization for use by authorized laboratories;
– This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
– The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
COVID Clinic makes no representations as to whether or not the testing services you receive from COVID Clinic or any third party laboratory will be reimbursable by your insurance provider.