INFORMED CONSENT FOR RAPID SALIVA COVID-19 SCREENING
This consent form is for individuals who present for the purpose of being screened for the novel coronavirus “COVID-19” using an investigational Rapid Saliva Viral Screening developed by 12-15 Molecular Diagnostics. The testing device, called Veralize, is a new, patented form of saliva-based viral testing that has not yet been evaluated and approved by the U.S. Food and Drug Administration (FDA). Clinical trials are currently underway. At this time, the results are for screening purposes only; they are not to be considered diagnostic. As noted in the Screening Questionnaire, if you are exhibiting signs or symptoms of COVID-19, have been in close contact with a COVID-19 patient, or are required to undergo a COVID-19 test for school or work, then you should NOT undergo this screening; rather, you should promptly contact your healthcare provider for evaluation and treatment.
Testing Process: By signing this form, you consent to 12-15 Molecular Diagnostics’ staff obtaining a small sample of your saliva that will then be screened for COVID-19 using the new device developed by 12-15 Molecular Diagnostics. The testing process will require you to spit once or twice into a wide mouth test tube. The screening procedures and all specimens are handled in accordance with all appropriate infection control measures. Your participation in this screening is entirely voluntary.
Reporting Results: The Rapid Saliva Viral Screen produces non-binding results within twenty minutes. You will be immediately informed of the results of the screen. Since this is only a preliminary screening, in the event that your screening yields a positive result, you should immediately present to an official testing site to undergo an FDA-approved COVID-19 nasal swab study in order to confirm your positive result. You will be offered a free COVID-19 test at a local partner hospital. We ask that you report back to the 12-15 Molecular Diagnostics researchers once you learn whether your nasal swab confirmation test was positive or negative. The information you provide will then be used by researchers to analyze the accuracy of the Rapid Saliva Viral Screen.
If the result of your screening is positive, this is an indication to self-isolate and/or wear a facemask in an effort to avoid infecting others until you obtain the results of the nasal swab test.
Confidentiality: Your personal information and screening results will remain confidential throughout the study. The results of your viral screening will not be reported to any individual or entity other than you.
I understand that 12-15 Molecular Diagnostics is not a medical provider, this screening for COVID-19 does not replace evaluation and treatment by my healthcare provider, and I assume full responsibility to take appropriate action with regards to my screening results. I agree I will seek medical advice, care, and treatment from my healthcare provider if I have any questions or concerns.
I understand that, as with any medical test, there is the potential for a false positive or false negative COVID-19 screening result.
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions and my questions, if any, have been answered to my satisfaction. I consent voluntarily to participate in this screening process.