The purpose of this form is to obtain your consent to obtain a serology sample and analyze it using an FDA-authorized (under emergency use authorization) rapid detection system to determine if you have antibodies directed against SARS-CoV-2, the virus that causes COVID-19. Please carefully read the items on this form and indicate your acknowledgment and consent to the following by signing in the spaces provided.
1. I AM INFORMED. I received and read the FACT sheet regarding the lab-selected rapid detection system. I understand this test is not a clinical trial and my participation is entirely voluntary.
2. Personal Information Privacy and Use of Results. Vanguard Genetics will not retain any right to test your sample for any purpose other than determining if you have antibodies directed against SARS-CoV-2. Your results may be anonymously pooled with the results of others in order to determine community prevalence or other statistics related to COVID- 19, and these results may be reported or published. However, under no circumstance will any personal information be made available to, or disclosed by, Vanguard Genetics, with the exception of this Consent Form.
3. Assumption of Risk and Release. I recognize that there are certain inherent risks associated with having my blood sample analyzed. I hereby consent for myself, my heirs, executors, administrators, assigns, or personal representatives, knowingly and voluntarily agree to have my sample analyzed by the lab-selected rapid detection system and hereby waive any and all rights, claims, or causes of action of any kind whatsoever arising out of my participation in this activity, and do hereby release and forever discharge Vanguard Genetics, its affiliates, managers, members, agents, attorneys, staff, volunteers, heirs, representatives, predecessors, successors, and assigns (collectively, “Vanguard Genetics”), for any physical or psychological injury, including but not limited to illness, paralysis, death, economical or emotional loss, that I may suffer as a direct result of my participation in this activity, including traveling to and from any location related to this activity. In the event that I should require medical care or treatment, I agree to be financially responsible for any costs incurred as a result of such treatment. I am aware and understand that I should carry my own health insurance.
4. Indemnification. I agree to indemnify and hold harmless Vanguard Genetics against any and all claims, suits, or actions of any kind whatsoever for liability, damages, compensation, or otherwise brought by me or anyone on my behalf, including attorney’s fees and any related costs, if litigation arises pursuant to any claims made by me or by anyone else acting on my behalf. If Vanguard Genetics incurs any of these types of expenses, I agree to reimburse Vanguard Genetics for these expenses.
5. FDA Guidance. I understand that the FDA has allowed the use of the lab-selected rapid detection system under Emergency Use Authorization even though it has not yet been formally approved. According to FDA Guidance, we are required to inform you of the following:
a. This test has not been reviewed by the FDA.
b. 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 should be considered to rule out infection in these individuals.c. 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.
d. 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.
e. This test is not for the screening of blood and blood products collected for the purposes of blood banking
