COVID-19 PCR Test (Ages 3+)

COVID-19 Testing Consent Form
I acknowledge and understand that I will perform one or more of the following specimen collections on myself based upon the type of testing that I have ordered: (i) a nasal swab for SARS-CoV-2 PCR testing; and/or (ii) finger prick for SARS-CoV-2 antibody (IgG) testing. SARS-CoV-2 is the virus that causes COVID-19. I acknowledge and understand that if I am purchasing nasal swab testing for SARS-CoV-2 PCR for a pediatric individual age 3-12 I will perform their nasal swab collection and if they are age 13-17 I will supervise their nasal swab self-collection. I further acknowledge, understand, agree, certify, and authorize the following:

1. I have requested testing of my specimen for SARS-CoV-2.

2. I am responsible for the collection of my specimen using the collection supplies provided to me by Clinical Enterprise, Inc. d/b/a EmpowerDX (“CEI”).

3. The SARS-CoV-2 PCR test involves a swab slid into the nostril to obtain a sample. It may be uncomfortable, painful, or potentially cause mild abrasion or bleeding. No long-lasting side effects from testing are expected. There is minimal risk with collection of a specimen with a nasal swab, but the nature of the collection may cause slight discomfort.

4. The SARS-CoV-2 antibody (IgG) test involves a finger prick. The risks and complications of the finger prick include the following: pain on the finger prick site, bruising, lightheadedness, inflammation around the finger prick site, and a rare risk of infection.

5. I understand that CEI, or its affiliate, Eurofins Viracor, Inc., (“Viracor”) will perform the laboratory analysis on my specimen if I order SARS-CoV-2 PCR testing. I authorize Viracor to perform SARS-CoV-2 PCR testing on my specimen.

6. I understand that CEI’s affiliate Boston Heart Diagnostics Corporation, (“Boston Heart”) will perform the laboratory analysis on my specimen if I order SARS-CoV-2 antibody IgG testing. I authorize Boston Heart to perform SARS-CoV-2 antibody IgG testing on my specimen.

7. Processing of the specimen and results may take between 3 to 4 days.

8. CEI, Viracor and Boston Heart will report my test result to EmpowerDX. EmpowerDX will make my test results available to the EmpowerDX Patient Portal. My test results will be available to me through the EmpowerDX Patient Portal.

9. These procedures and the results are not a substitute for medical advice or treatment from my personal health care provider. I will consult with and obtain care from a health care provider if I have tested positive for COVID-19, am experiencing symptoms, or have any other questions or concerns.

10. I am not entering into a doctor-patient relationship with Michael J. Bauer, MD, CEI, Viracor, or Boston Heart. Any questions that I have, or coordination of required follow up with a health care professional, is my responsibility.

11. CEI, Viracor, and Boston Heart have infectious disease reporting responsibilities under applicable governmental regulations and will report my testing information in accordance with applicable regulations.

12. By submitting my health insurance information with the at-home COVID-19 test request, I consent to information about my results and testing to being shared with the health insurer paying for my testing for purposes of payment, treatment, and/or health care operations as described in EmpowerDX’s HIPAA Notice of Privacy Practices.

By clicking below, I acknowledge that I have read, understand, agree, certify, and/or authorize the information above and further agree that I and my heirs, executors and assigns hereby release Michael J. Bauer, MD, CEI, Viracor, and Boston Heart, including their respective employees, agents, and contractors from any and all liability and claims. I authorize CEI, Viracor and Boston Heart and their respective employees to use and/or disclosure the PHI as described above. I do hereby expressly and voluntarily authorize this use and release of information and declare that the information provided on this form is true and correct.

Fact sheets:

For Healthcare Providers: https://www.fda.gov/media/140978/download
For Patients: https://www.fda.gov/media/146326/download

Last Updated 02 July 2021