Test Kit Usage Waiver

We are making available to you a home bleed kit, which will be processed utilising the BioCard™ Testing platform within our professional laboratory in the UK (the “Test Service”).

By placing your order for the Test Service, and ticking the box, you agree to the following terms:

    1. You confirm that you have read and agree to follow all instructions relating to “how to use the kit” and other instructions relating to the Testing Service and understand the information provided.
    2. By agreeing to these Terms you guarantee that any sample you send does not contain a communicable disease, (e.g H.I.V., and/or guarantee that you have not had COVID-19 symptoms, or been in contact with any persons known to have COVID-19, in the past 14 days.
    3. In certain circumstances, we may contact you to recommend, or notify you of updates to the service, recommendations for re-testing, and/or related products that may assist in the mitigation of COVID-19 virus, or otherwise assist in the protection or treatment the COVID-19 infection.
    4. The Test Service detects antibodies to the SARS-COV-2 virus, based on a sample of blood from your finger (or venous draw if you choose at your sole discretion). You are purchasing a Test Service that includes a home bleed kit which you will administer yourself in a home setting. The result of the Test Service depends on your own management of the testing process and your understanding of the test result.
    5. We cannot guarantee the outcome of the home bleedkit, or the Test Service to which it relates, which you administer yourself, and the purchase of the Test Service does not constitute our professional medical advice to you. Only you know the person to which the blood provided and thereby to whom the result relates. We exclude all liability as a professional advice giver, or medical doctor, or other medical professional. For medical advice, you are advised to engage with private consultant, (for which there will be a service charge), or otherwise, contact your doctor or local surgery or the NHS helpline.
    6. For reasons of hygiene under no circumstances can a home bleed kit be returned to us, and no refund will be given. As a one-use perishable item, no return is possible except in the event that the home bleed kit arrives damaged or incomplete, in which case immediate return of the unused (and un-opened) home bleed kit should be made and evidence of the damage or incomplete home bleed kit should be supplied.
    7. If you fail to follow the instructions, and send an insufficient sample contrary to instructions, you agree that we are under no obligation to refund you for the Test Service. Depending upon the circumstance, we may allow you to purchase replacement components if they are available to us, which enable you to re-supply the sample at a reduced cost to you that having to repurchase the Test Service completely. This offer will be solely at our discretion, and would only be made available once.
    8. We exclude all liability for any claim by you or any third party for any damages or losses arising out of or in relation to, or purported to relate to, the Test Service, howsoever arising and whether consequential, direct or indirect. While we will endeavour to return test results to you as swiftly as possible, we specifically exclude all liability for any delays in the test results caused by the royal mail in the delivery of samples and/ or email communication errors, omissions or failures. This exclusion shall not operate to exclude any liability that may not be excluded by law.
    9. We have endeavoured to design the Test Service with use of a CE marked blood drawing kit, specifically in combination with the COVID-19 BioCard™. Use of any other finger prick blood drawing device kit, will invalidate your results and should not be used. The BioCard™ is specifically designed and validated to function correctly with either finger prick attained blood, or venous draw bloods. If you are unable to attain sufficient blood a “gold top” venous tube is also validated, and should be performed by a fully qualified professional. Phlebotomists services are widely available, and usually charge for their services.
    10. The home bleed kit, and the BioCard™ it is validated to operate with, has been thoroughly tested to provide accurate and correct results pertaining to the sample you present to it according to the specification of the test. The specifications of the test operate in an ISO regulated facility, which inherently operates a system of continual improvement. The specifications and accuracy of the BioCard™, may be updated without notice at any time according to the information available at the time. Provided you observe and follow all the instructions optimally, the Test Service is considered to have an accuracy of >99.5% sensitivity and >99.5% specificity based on the results of the validity study pertaining to the test.
    11. The test is recorded against validity data for its CE mark as having a sensitivity of 100% and 99.4% against true 72 positive samples and 180 true negative samples to the specific spike antibodies to SAR-COV-2. Cross reactive studies were carried out when validating the test which demonstrated no cross reactivity against those it was tested against, which included other respiratory diseases and coronavirus.
    12. Whilst this infers a very high degree of confidence in any results, in very rare cases, in the potential context of a global population of 8.8 billion individuals it remains possible that the test may detect antibodies that are not due to a past COVID-19 infection, (none-specific binding), or be unable to detect antibodies which are otherwise proved present when sampled on the same day (Undetectable levels, and/or a true false negative).
    13. Positive and negative predictive values are dependent upon local incidence (true positive PCR results), and/or clinical histories that you hereby acknowledge are known solely to you, and/or those you are acquiring the service for.
    14. Any actions taken by you, or the individuals you are acting for when placing your order for this service, or decision or conclusions you reach, following Test Service results, are your own responsibility and arrived at based on your own conduct of your test and your free will and choice of action. We exclude all liability and responsibility for the action you take following your Test Service result and provide no consultation or medical advice to you on the basis of your Test Service results.
    15. You confirm that the email address provided for use with the service, is your own, and/or you are authorised, or have authorisation, from anyone receiving the test results, to use the email address which you have provided with the Service. (If purchasing tests on behalf of others, and any person does not wish to share their results with you, they are able to create an account using the unique code you give them, and access their results anonymously if preferred).
    16. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it. If you choose to delay asking for medical treatment on the basis of the Test Service results, you do so solely at your own risk.
    17. You hereby consent that should a sample of your blood remain, that it may be stored as a “retain”, to enable us to comply with good regulatory process and demonstrate the accuracy of results at a later time. Samples will be anonymous according to the ID known only to you and destroyed without notice not later than 24 months after our receipt.
    18. It is important that you continue to follow any and all local or national government irrespective of the Test Service result. Any Test Service result pertains only to the date the sample was taken and it not on-going evidence of any presence of antibodies nor of assumed immunity.