CONSENT - S1 COVID TEST NDA - Spike Protein lab tests with Radiance Diagnostics

IMPORTANT NOTICE

The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is not required to use the test for this consent.

IF YOU ARE EXPERIENCING AN EMERGENCY CALL 911

Patient First Name

Patient Last Name

Patient Date of Birth

Phone Number

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I the undersigned patient or representative or legal guardian of the minor named above, give the following consent.

I am attempting to learn more about the Covid-19 spike burden in my body from having had the mRNA vaccine or having contracted Covid-19.

My "referring provider" has informed me that I may benefit from the test described by this Consent (the "Test"), because the test "Basic S1 Immune Subset Panel" may help my referring physician select the most viable avenue for detoxifying my body.

I do not have a Provider

I am not working with a provider and would like Dr. Bain to oversee my case.

I’m working with a Provider

I am working with a provider who will oversee my case. Enter your providers information below.

Referring Provider

Referring Provider ADDRESS, PHONE and EMAIL

We will send your results to your referring provider

CONSENT AND TERMS:

I give consent to include my results to be submitted and analyzed by the S1 Spike Study Team to understand the efficiency of the protocol that I am undertaking. My results will only be shared upon this study team of providers.

I do not wish to be included in the study.

The test determines if I am still encumbered with spike protein which may still challenge my immune system. The test measures S1 spike proteins in monocyte and analyzes if spike protein is still attached.

The test was developed by IncellDx, Ca, and its performance characteristics were determined by Radiance Diagnostics. Radiance will conduct the test at Radiance's laboratory, which is separate from Dr. Alan Bain, D.O.'s office. Within 5-7 business days after Radiance received the blood specimen, Radiance will prepare a report indicating the results of the test, which Radiance will deliver to the ordering Physician, Dr. Alan Bain, D.O. and forwarded to your referring physician.

The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is not required to use the test for this consent.

Radiance is a CLIA-Certified high-complexity laboratory. Dr. Alan Bain, D.O. will remit payment for the test to Radiance.

PLEASE CHECK THE FOLLOWING STATEMENTS INDICATING YOUR UNDERSTANDING:

The cost of the test may not be covered by my insurance. I understand and I am financially responsible for the full cost of the test, and I voluntarily consent to pay the Dr. Alan Bain, D.O. for the test in full, in advance and in the amount of $360.00 USD (the test cost). This test is given at a specialized discount to protect any conflicts of interest.

I agree to an informed consent consultation from Dr. Alan Bain, D.O. concerning the Test in addition to the above information. I understand the consult fee with Dr. Alan Bain is $54 and included in the total payment. I will contact Dr. Alan Bain's office to schedule once my results are completed.

I will refrain from discussing the results of my lab, the test price or information obtained during this process publicly, privately and on any social media and chat group.

I understand that COVID Long Hauler Cytokine panel, S1 and Immune Subset panel tests are Laboratory Developed Tests (LDT). This test panel was developed by incellDx and their performance characteristics were determined by Radiance Diagnostics, which is certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity testing. The U. S. Food and Drug Administration (FDA) has not reviewed, approved, or cleared these tests.

I understand that the laboratory tests performed at Radiance Diagnostics are done at my request. In consideration for receiving the opportunity to participate in laboratory testing , which is provided by The Radiance Diagnostics, I hear by release, waive, discharge, covenant not to sue, and agree to hold harmless for any and all purposes company and their healthcare staff, members, shareholders, officers, servants, agents, volunteers, or employees (herein referred to as “indemnities”) from any and all liabilities, claims, demands, injuries, (including death), or damages, including court costs and attorney’s fees and expenses, that may be sustained by me while participating in testing.

I am fully aware that, the company is not providing medical care or medical diagnosis with Testing. I further understand that it is my responsibility to consult my own medical doctor for interpretation, analysis, evaluation, and explanation of my test results. I understand that neither Radiance Diagnostics nor its ordering physician will analyze, evaluate, critique, or otherwise interpret the results of said tests. I agree that Radiance Diagnostics, its officers, shareholders, directors, employed physicians or its other agent or employee shall not be liable for any claims including, but not limited to, any claim arising out of or related to, inaccurate, uninterrupted, misinterpreted or results not received and do hereby expressly forever release and discharge all claims, demands, injuries, damage, actions or causes of action.

I hereby waive my rights regarding protected health information under HIPAA, to the extent necessary to complete the Testing and to allow Company to provide the results of Testing to the organization which has arranged for the testing or me. Protected health information will not be reused or disclosed by Company to any person or entity other than above, except as required by law.

I understand that there is no refund once the kit has been ordered through Dr. Alan Bain, D.O.

Typed Signature

By typing your name above, you acknowledge this is your legal binding signature.

PLEASE ANSWER THE FOLLOWING QUESTIONS TO THE BEST OF YOUR KNOWLEDGE:

If yes, what is the date of your most recent test?

How many times have you been infected with or believe you've been infected with Covid-19 by year?

2019

2020

2021

2022

2023 and later

Since having had Covid-19, have you received new diagnosis?

If yes, how man clinics have your been to?

If yes, which company developed the covid-19 vaccine you received?

Moderna

Pfizer

J&J

Other

The Covid-19 vaccination program was rolled out early in December 2020 with 50% of the total vaccinations being conducted by the end of June 2021. What is the approximate date of your FIRST vaccination(s)?

December 2020-March 2021

April 2021-June 2021

July 2021-December 2021

January 2022-December 2022

During 2023 or later

I cannot remember

Please indicate how much you agree with the following statement: The covid-19 vaccine NEGATIVELY effected my health

Strongly Agree

Agree Somewhat

Neither Agree or Disagree

Disagree Somewhat

Strongly Disagree

Please list any symptoms that you believe may have been caused by the vaccine.

How long have you had these symptoms?

How many specialists and traditional doctors have you seen?

Please list any supplements you are currently taking.

Please list any other medications you are currently taking.

Please list any medications and treatments you have tried, but failed.

Please list any disease diagnosis or chronic condition that occurred before your vaccination

Have any of these conditions gotten worse after taking the covid-19 vaccination? If yes, what condition worsened and how?

Please list any disease diagnosis or chronic condition that occurred after your vaccination.

PLEASE NOTE:

You are responsible for finding a phlebotomist to draw your blood and any fees associated with that service. We suggest https://www.anylabtestnow.com/

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