Informed Consent For Rapid Antibody (Igm/Igg) Testing

The test being provided is a rapid antibody test that has an FDA Emergency Use Authorization (EUA) for use in the US. You understand that the test has not been officially approved for use in a physician’s office or for a point of care setting.

This test is a rapid results test with results produced within 15 minutes.

Even if the test is negative, please be advised that you may still have COVID-19 or have acquired the infection in the last 7 days. Negative tests do not rule out a COVID 19 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 or to inform infection status.

Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID 19 infection or to inform infection status, as any test can have both false positive and false negative results.

Positive results may be due to past or present infection with non COVID 19 strains, such as coronavirus HKU1, NL63, OC43, or 229E.

A negative IgM/IgG test does not preclude you from having a recent COVID19 infection that occurred in the last 7 days. In other words, a negative IgM and negative IgG could still mean you are positive to COVID-19 especially if you have symptoms. DO NOT rely on a negative test result.

REPORTING OF TEST RESULTS:
The COVID-19 test results will be given to you directly OR you will be notified by email or text of your results.

RELEASE OF TEST INFORMATION:
Per Title 17 Section 2500 of the California Code of Regulations, cases of Coronavirus Disease 2019 (COVID-19), must be reported to the local health officer for the jurisdiction where the person resides.
You may request a photocopy of the lab result
You have the right to a copy of this authorization form

TREATMENT OPTIONS:
You understand that you have responsibility for finding your own treatment and discussing with your own doctor the significance of your testing. You may book an appointment for a consultation with a health care provider at: info@arkclinicalresearch.com . The cost for consultation is: $125 per 10-minute slot and will be charged upfront to reserve the MD time.

CONSENT FOR USE OF DATA FOR RESEARCH STUDIES:
As little is known about the epidemiology of COVID 19, you are agreeing that we can report your data in a non-identified (anonymous) summary form and collaborate with other researchers who are collecting data on this condition for no compensation. Samples may also be saved for future study looking at the characteristics of the assays being used.

TEST INTERPRETATION:
Any test can be wrong, In other words, any test can have a false positive or false negative result. If you have a negative Antigen, but you have symptoms of COVID-19, the negative result in the PCR could be wrong and should be repeated or you should get a PCR.

RELEASE OF LIABILITY:
I agree to release Cosmos Health Solutions and its employees and subcontractors for any and all liability regarding anything related to the processing of samples, notification of results, actual test results, or any other unforeseen problem. I understand that the test being performed is not fully understood in terms of the accuracy and may have both false negatives or false positives.

CONSENT AND SIGNATURE:
I authorize Cosmos Health Solution to notify me of the test result and provide me with guidance for medical follow up. I authorize for physician or health care provider affiliated with Cosmos to have access to and disclose my test results to me. I consent to provide my phone number and email released to the local Health Department where I live if required by law.