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Terms and Conditions for COVID-19 Neutralizing Antibody Test

If you are experiencing severe symptoms, please contact your health care provider. If you are experiencing a life-threatening emergency, please call 911 immediately.

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I authorize VaxGuard, a service of FirstVitals Health and Wellness Inc and Predicine Labs to collect a blood sample from me (or my child/dependent named in the Test Requisition) for SARS-CoV-2 Neutralizing Antibody Testing in accordance with the Terms and Conditions.

I understand, acknowledge, and accept that I (or my child/dependent) may experience discomfort or other negative reaction as a part of or result of the Testing Service. This discomfort or other negative reaction is inherent to the testing process.

I understand, acknowledge, and accept that either VaxGuard or Predicine Labs may use email, SMS and verbal communication to transmit my test results to me, and I understand the potential risks that may arise. I understand that test results containing my personal health information will be sent to either the email address or mobile phone number I voluntarily enter on the test registration form. By entering an email address or mobile phone number that belongs to another individual, I hereby authorize VaxGuard or Predicine Labs to send my test results and personal health information to that individual.

I understand, acknowledge, and accept that Predicine Labs may deliver my test result outside of the specified time frame depending on current laboratory capacity. Predicine Labs reserves the right to adjust turnaround time and test result delivery without prior notification. Invalid tests may be re-processed to obtain a new result.

I understand that I should contact my healthcare provider to discuss the outcomes of this test.


 SARS-CoV-2 Neutralizing Antibody Test

TERMS AND CONDITION

 

Overview

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  1. This agreement (“This Document”) dictates the Terms and Conditions for the conduction of COVID-19 Neutralizing Antibody Testing Service ("Testing Service") through VaxGuard and Predicine Labs and its personnel, employees and affiliates, to the Test Recipient.

  2. This Document, in addition to the agreements made by the Test Recipient as part of the registration process (electronic registration form) for receiving COVID-19 Neutralizing Antibody Testing, comprise the entire agreement between the parties.

  3. This Document supersedes all prior agreements, understandings, representations and all forms of prior communication between Predicine Labs and the Test Recipient.

  4. I am the Test Recipient named below or I am the parent or legal guardian (if the Test Recipient is a minor or dependent) of the Test Recipient named below.

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COVID-19 Neutralizing Antibody Testing

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  1. Predicine Labs shall provide COVID-19 Neutralizing Antibody Testing Services to the Test Recipient in accordance with This Document.

  2. Blood samples (Test Samples) will be collected from a self-collection finger stick by the Test Recipient.

  3. The purpose of the Testing Service is to determine whether the presence of neutralizing antibodies can be detected in the sample collected from the Test Recipient at the time of testing (Test Results). No other test results or information are expected to be determined or supplied.

  4. It is the responsibility of Test Recipient to determine how Testing Service is covered by Test Recipient's health care insurer.  Currently under a public health emergency, it is anticipated insurance and government programs will cover the cost of the COVID-19 Neutralizing Antibody Test.

  5. While an estimated time frame for receiving Testing Service result is provided, unknown factors, including high demand for Testing Service, could result in delays in the delivery of results. The time between when a Test Recipient is tested and when the Test Recipient’s results become available may be unpredictable. Predicine Labs. will provide an estimated time of result availability, but makes no guarantee the results will be provided at that time. Predicine Labs will be communicative about any delays in sample results.

  6. The Testing Service is not 100% accurate, cannot be used to guarantee COVID-19 vaccine efficacy or protection against COVID-19 infection.

  7. Additional testing may be required depending on the results of the test, including if a result is inconclusive.


Test Recipient Requirements

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  1. The Test Recipient (or parent/legal guardian) must accurately complete all necessary portions of the Test Requisition Form; provided as part of the registration process, usually through the online survey, including providing answers to health questions, medical information, and exposure history.

  2. The Test Recipient must cooperate with Predicine Labs in all matters in regards to Testing Service. Full cooperation during the sample collection process is critical for the safety of the Test Recipient and Predicine Labs personnel. Test Recipient must follow all instructions provided by clinical staff. Failure to comply with these instructions may result in insufficient sample collection, invalid test results, and delays in receiving test results. Predicine Labs is not responsible for damages, delays, or any other consequences resulting from insufficient sample collection.

  3. Test Recipients who are minors aged 17 and under must be accompanied by a parent or legal guardian during the specimen collection procedure.

  4. The Test Recipient must allow access to the Test Recipient’s physical health information, records, and medical information as may reasonably be requested or required by Predicine Labs for the purposes of performing the Testing Service.

  5. The Test Recipient must respond to any of Predicine Lab’s requests for additional information, authorizations, or decisions that are reasonably necessary for Predicine Labs to perform Testing Service in accordance with the requirements stated in This Document.

  6. The Test Recipient must provide such Test Recipient materials or information as Predicine Labs may reasonably request to carry out the Testing Service with the provided turnaround time. Test Recipient shall ensure that such Test Recipient materials or information are complete and accurate in all material respects.

  7. The Test Recipient understands and acknowledges that accurate processing of Testing Service is contingent on Test Recipient promptly providing full, complete, and accurate medical information to Predicine Labs.

 

Potential Risk and Discomfort

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  1. The Testing Service procedure could involve some degree of discomfort, invasiveness, distress, dissatisfaction, and/or other negative reaction. Test Recipient acknowledges this fact, and acknowledges that he/she may experience them as a result of receiving Predicine Labs Testing Service.

  2. The Test Recipient understands, acknowledges, and accepts that any discomfort, invasiveness, distress, and/or other negative reaction is inherent to the testing process and not a result of any misuse of the testing materials by Predicine Labs. Test Recipient agrees that Predicine Labs cannot be held liable for any discomfort, invasiveness, distress, and/or other negative reaction experienced by Test Recipient as a part of or result of the Testing Service.

  3. Nothing in This Document shall serve to exempt Predicine Labs and its partners, affiliates, assigns, employees, contractors, and other relevant parties from liability for gross negligence, intentional misconduct, or other liability un-waivable by law.

 

Protecting Test Recipient Privacy

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  1. All of the Test Recipient’s confidential information, including medical and financial information, shall be protected in accordance with Health Insurance Portability and Accountability Act (HIPAA) regulations, as well as standard industry practices. Exception may be made for any required disclosures to the Test Recipient’s employer or Federal, State, or Local governments.

  2. VaxGuard and Predicine Labs represents and warrants that with respect to all Protected Health Information (PHI), it is a Covered Entity under HIPAA Regulations and that it will protect the confidentiality, privacy, integrity, security, and availability of the PHI disclosed to, used by, or exchanged by the parties.

  3. Test results (Result Reports) are primarily sent with encrypted email or fax, but other methods, including phone or mail may also be used upon request by the Test Recipient, or depending on the circumstance.

  4. VaxGuard and Predicine Labs will use reasonable means to protect the privacy of the Test Recipient’s PHI, including test results, but the Test Recipient acknowledges the inherent risk of potential disclosure of test results.

  5. The Test Recipient also acknowledges the risks of using certain methods of unencrypted communication, as well as the possibility that someone who has access to the Test Recipient’s devices may be able to access private information.

  6. The Test Recipient consents to VaxGuard and Predicine Labs providing their Results Report through encrypted email, secured text messaging or fax, and releases Predicine Labs from any liabilities that may arise from the inherent risks in using these methods for the delivery of Result Reports.

  7. The Test Recipient may voluntarily enter email addresses or mobile phone numbers belonging to other individuals on the test registration form. Test Recipient acknowledges that their test results containing PHI and personal information will be sent to those email addresses. By entering those email addresses on the registration form, Test Recipient consents to those individuals receiving Test Recipient's test results and PHI.

 

Disclosure to Test Recipient’s Employer

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  1. If the Testing Service is paid for or facilitated through Test Recipient’s employer, the Test Recipient understands and acknowledges that Test Recipient’s employer may receive the results of Test Recipient’s test, regardless of Test Results. 

  2. Test Recipient understands, acknowledges, and agrees to the providing of the necessary personal and medical information to Test Recipient’s employer.

  3. The employer’s use of that information with respect to Privacy Laws will not be monitored by VaxGuard or Predicine Labs, and VaxGuard and Predicine Labs shall not be liable for the employer’s use or misuse of any data, testing results, personal or medical information, or any other information provided as a result of the Testing Service. 

  4. The Test Recipient agrees to waive any applicable HIPAA protections that prevent VaxGuard and Predicine Labs from disclosing Test Recipient's Protected Health Information only to the extent of providing Result Reports to the Test Recipient’s employer. 

  5. Authorization to disclose Test Results to the Test Recipient's employer shall be in effect for one year from the date of sample collection.

  6. The Test Recipient has the right to revoke this Authorization at any time by providing a written and signed request to VaxGuard or Predicine Labs. This revocation will be effective upon receipt, but will have no impact on disclosures made prior to the revocation.

 

Disclosure to Regulatory Bodies and Government Agencies

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  1. Test Recipient understands, acknowledges, and agrees that the results of Test Recipient’s Testing Service administered under This Document is permitted to be disclosed to the applicable Federal, State, and/or Local governments.

  2. VaxGuard and Predicine Labs shall not be liable for the applicable Federal, State, or Local governments’ use or misuse of any data, testing results, personal or medical information, or any other information provided as a result of the Testing Service.

  3. The Test Recipient expressly agrees to waive any applicable HIPAA protections only to the extent necessary to disclose test results to Federal, State, and Local governments.

 

Ownership of Intellectual Property, Confidential Information, and Data
 

  1. Test Recipient acknowledges and agrees that VaxGuard shall hold right and title to any intellectual property rights in and to the results of the Testing Services (with identifiable patient information removed) including any derived works or information created from or with the results of the Testing Service.

 

Disclaimer of Warranties

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  1. Except for the representations and warranties expressly set forth in This Document, VaxGuard and Predicine Labs makes no representation or guarantee whatsoever regarding the use or misuse of Test Recipient information provided.

  2. Except for the representations and warranties expressly set forth in This Document, VaxGuard and Predicine Labs makes no representation or guarantee whatsoever regarding the accuracy of Testing Service results ensuing from improper performance of the self-collection blood kit or inaccurate Test Recipient information.

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Limitation of Liability

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  1. In no event shall Predicine Labs be liable to the Test Recipient or to any third party for any loss of use, matters regarding employment, pain and suffering, distress, or for any consequential, incidental, indirect, exemplary, special, or punitive damages whether arising out of breach of contract, wrongful conduct, or negligence.

  2. VaxGuard and Predicine Labs will take precautions to avoid transmission, spread, or exposure to COVID-19. However, the Test Recipient acknowledges that the risk of potential exposure cannot be fully eliminated. The Test Recipient consents to any reasonable risk of exposure which may arise from the Testing Service procedure.

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Acknowledgement

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  1. I authorize VaxGuard, a service of FirstVitals Health and Wellness Inc and Predicine Labs to collect a blood sample from me (or my child/dependent named in the Test Requisition) for SARS-CoV-2 Neutralizing Antibody Testing in accordance with the Terms and Conditions.

  2. I understand, acknowledge, and accept that I (or my child/dependent) may experience discomfort or other negative reaction as a part of or result of the Testing Service. This discomfort or other negative reaction is inherent to the testing process.

  3. I understand, acknowledge, and accept that VaxGuard or Predicine Labs may use email, SMS and verbal communication to transmit my test results to me, and I understand the potential risks that may arise. I understand that test results containing my personal health information will be sent to the email addresses I voluntarily enter on the test registration form. By entering an email address or mobile phone number that belongs to another individual, I hereby authorize VaxGuard or Predicine Labs to send my test results and personal health information to that individual.

  4. I understand, acknowledge, and accept that VaxGuard or Predicine Labs may deliver my test result outside of the specified time frame depending on current laboratory capacity. Predicine Labs reserves the right to adjust turnaround time and test result delivery without prior notification. Invalid tests may be re-processed to obtain a new result.

  5. I understand that I should contact my healthcare provider to discuss the outcomes of this test.

  6. I understand, acknowledge, and accept that I must follow all instructions provided to me by VaxGuard or Predicine Labs staff. Failure to comply with these instructions may result in insufficient sample collection, invalid test results, and delays in receiving test results. VaxGuard and Predicine Labs is not liable for any damages, delays, or other consequences resulting from insufficient sample collection.

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