COVID-19 Informed Consent

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Consent to COVID-19 testing

You are providing consent for COVID-19 testing. COVID-19 testing includes specimen collection (nasal swab), and the testing of that specimen for the presence of the virus that causes COVID-19 (SARS-CoV-2).When the test is complete, results will be returned to you, to the ordering physician, and when required by law, to certain federal, state, or local agencies for public health purposes. If you have provided a HIPAA authorization, the result will also be shared with the sponsor of the testing program.

  • Some important clinical considerations
    • Your specimen may be collected via anterior nares, nasopharyngeal or oropharyngeal swabs. Samples can be self-collected or collection can be administered by a third party subcontracted service. The most common risks associated with such collections are mild pain or discomfort, a little gagging, or a minor nosebleed.
    • The test detects if you have SARS-CoV-2 (the virus that causes COVID-19) at the time of sample collection only. It does not test for immunity or if you had the virus in the past. More details about the COVID-19 Test, including the Patient Fact Sheet, are available at https://www.color.com/covid19-details.
    • If your results are positive, please contact a doctor immediately. Only a doctor can give you a diagnosis. The doctor can also provide information on how to care for yourself and how to help protect others from infection.
    • Negative results mean that the virus was not detected. If you’re feeling symptoms, contact a doctor and ask whether you should be retested because:
      • You may have contracted the virus after your test.
      • Your test may have been a false negative. False negatives occur because the tests are not perfectly accurate.
    • Color does not give medical advice or provide medical care. Follow up with your doctor about your results. If you are experiencing a medical emergency, call 911 immediately.  

 

  • Some other important considerations
    • When testing is complete, the virus present in positive samples may be further analyzed for public health purposes. De-identified specimens and data may be used for COVID-19-related quality assurance, validation and laboratory testing development. 
    • If you are being offered the COVID-19 test as part of a program sponsored by an organization (e.g., school, employer, etc.), such organization shall be referred to herein as the “COVID-19 Testing Program Sponsor,” and the following may also apply:
      • By providing your consent, you are agreeing for these terms to apply each time you receive a COVID-19 test through your COVID-19 Testing Program Sponsor’s program, on such recurring basis as will be communicated to you by your COVID-19 Testing Program Sponsor (directly or through Color), for six (6) months following the date that you provide this consent; 
      • If you wish to revoke your consent at any time over the six-month period that it is in effect, prior to receiving a COVID-19 test during your COVID-19 Testing Program Sponsor’s program, you may do so by emailing support@color.com.  Please note though that you will be unable to participate in testing with the program if you revoke your consent, and any revocation will not apply to testing received under the program prior to Color processing your revocation request.

 

Last updated: December 20, 2021