Device: BD Veritor System for Rapid Detection of SARS-CoV-2
Indication: Qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.
Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
I understand and agree that local health guidelines include the reporting of positive test results to the County Health Department to enable contact tracing and limit spread of the disease and I hereby consent to such reporting in the event I test positive.
10 Minutes Rapid Detection of SARS-CoV-2 (COVID-19) N-Protein Antibodies Test Kit.
HealGen Scientific LLC offers lateral flow devices for the detection of IgG and IgM antibodies to the coronavirus N-protein in serum, plasma, and peripheral blood. An example of a lateral flow device is a home pregnancy test. They are easy to use and provide rapid results.
This rapid test is for in vitro diagnostic use, following guidance from the FDA for Emergency Use Authorizations of tests submitted for approval on March 16, 2020. The tests have not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
IgG/IgA/IgM Antibody Detection Kit (Indirect ELISA)
N-Protein and S-Protein (S1 subunit, RBD) human antibody detection kits (Indirect ELISA method) for the semi-quantitative measurement of human IgG, IgA, or IgM antibody against SARS-CoV-2 in serum or plasma.
I am voluntarily on my free will, allow Relany LLC dba: CryoFit of Milwaukee to:
Blood Test Consent and Release Form. I hereby consent to the drawing of a blood sample for the purpose of COVID-19 antibody test. I have had the opportunity to read and consider the Relany LLC Privacy Practices Notice to my satisfaction prior to consent. I accept that services, including counseling/explaining of results, might be rendered in a non-private setting. Furthermore, I hereby release and forever discharge for myself, my heirs, executors, administrators and assignees, Relany LLC and their employees, owners and representatives, as well as the company sponsoring this event and their agents, representatives, employees, successors, assignees, governing bodies, and advisory committees from any and all claims, demands, actions and causes of action, which may result from participation in this program. I understand and accept that: 1. Data derived from this test is to be considered preliminary only and does not constitute any kind of diagnosis. 2. The responsibility for initiating a follow-up examination to confirm results and obtain professional advice and medical treatment is mine and not that of Relany LLC or any other organization associated with this screening. 3. Relany LLC will keep my results strictly confidential and may release only aggregate data to my employer or other organizations. 4. Relany LLC will keep my results strictly confidential and may release my data to a 3rd party vendor, which will anonymize it before sending it to my employer for the purposes of wellness program development.
Today's Date: June 18, 2021