Circle Informed Consent

This Informed Consent is provided by Prenetics Limited, which together with its affiliated companies, is collectively referred to herein as “Prenetics”, “we”, “us” or “our”. Prenetics is the provider of Circle Snapshot Heart Health Test (Vital), Circle SnapShot Food Sensitivity Test (Essential), Circle SnapShot COVID-19 Antibody Test, and the “Service”.

This Informed Consent:

1. reviews the benefits, risks and limitations of the Service which you have selected;
2. explains how your personal information, personal health information, laboratory results and data, and biological sample will be used in connection with the Service; 
3. seeks your acknowledgement and consent to this document, the risks and limitations, and to our processing of your biological sample and information in connection with your Service; 
4. seeks your consent to receiving direct marketing materials; and
5. where the client is under the age of 18, seeks parental consent.

Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and biological sample is being provided for the Service. If you are a parent or guardian requesting the Service for a minor (as permitted by our Terms of Service depending on your country of residence), “you” may also refer to “your child or ward”, as contextually appropriate. 

In order to proceed with the Service, you must confirm that you have read, understood, and agree to this Informed Consent.

Voluntary participation

Your use of the Service is voluntary. It is your choice whether to use our Service or not. Prior to proceeding with the Service, you (and your guardian or parent, as appropriate) may wish to speak with a healthcare provider.

What we collect and how it is used

• Personal Information. If you request a Service or create an account, you will be asked to provide certain information, including personal information. We will only collect information that is necessary for our provision of the Service to you. 
• Biological sample. You will also be asked to provide a biological sample in accordance with our collection procedures. Your sample and Personal Information will be transferred to our laboratory or third party laboratories designated by us for processing and analysis in order to deliver our Service to you. 
• Personal Health Information. You may voluntarily provide additional personal health information via surveys. 
• Regulatory compliance, Internal quality control, Validation studies. Your biological sample may also be processed for regulatory compliance, internal quality control and validation studies. 
• Further opt-ins. You may consent to future products or services, or opt-in for third party research and our research database, as described below. We will not use your information or report on matters beyond those relevant to your ordered Service without your consent.
• Direct marketing. We will obtain your consent or indication of no objection before using your personal data for direct marketing purposes. You may, at any time, request that we cease using your personal data in direct marketing by contacting us at privacy@prenetics.com 

‍Important Notes: 

• For the Service to perform as intended, you must provide accurate and correct information. Failure to do so may result in your biological sample not being tested. 
• If another person is submitting information on your behalf, by agreeing to this Informed Consent, you represent and warrant that such person is authorized to provide such information and that all such information is accurate and correct. 
• In the event we determine that a biological sample is not suitable for processing and analysis due to incorrect collection, contamination of sample or violation of this consent or the TOS, we reserve the right to terminate the Service to you without providing any refund. 
• You are responsible for ensuring that by providing your biological sample, you are not violating any export ban or other legal restriction in your country.

Further details on the use of your information are set out under “Use of Your Information” below.

Leading risk factors for heart disease include high blood pressure, high blood cholesterol, diabetes, smoking, obesity, unhealthy diet, physical inactivity and genetics. The Heart Health (Vital) test is used to screen and monitor the risk of cardiovascular diseases. It quantitatively measures biomarker level of Total Cholesterol (TC), High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), Triglycerides (Trig) and high-sensitivity C-Reactive Protein (hs-CRP) in blood through TAP II blood collection device. Lipid profile measurement helps to determine the risk of plaque buildup in the arteries that lead to narrowed or blocked arteries (atherosclerosis). When the level of blood cholesterol rises, so does the cardiovascular disease risk. The level of hs-CRP increases when there is inflammation in the body and it is one of the indicators for cardiovascular diseases. And if other risk factors are present such as smoking, high blood pressure or diabetes present at the same time, the risk of cardiovascular disease development increases even further. The test provides information on biomarker ratios in the form of TC/HDL ratio, Non-HDL and Trig/HDL ratio. The higher the ratios, the higher the risk in developing heart disease.  

The TAP II Blood Collection Device is a clot activator with gel separator single use device intended to be used to collect capillary blood from the upper arm of individuals for self-sample collection  at home. The collected sample needs to be transported to our laboratory for analysis to determine the biomarker levels using photometric quantitative technology.

.The Heart Health test can be used routinely to monitor heart health related biomarkers level that can  provide information on cardiovascular diseases development risk. If an individual has high total cholesterol, high LDL, low HDL, high triglycerides or high hs-CRP levels, there is increased risk in heart disease development. Individuals can take actions in changing their lifestyle, diet and/or medications under the instruction of a physician or dietitian to improve the biomarker levels. This may help to lower an individual's risk of developing cardiovascular diseases, such as heart attack and stroke. It may also be used to monitor the body's response to cholesterol treatment.

When you are collecting the blood sample, the prick may affect healing if the prick site is already damaged. There is also a risk of infection or tissue death (a long-term effect) at the prick site. If the blood sample is collected by the TAP II device, the prick may cause an allergy reaction if you are allergic to stainless steel. If the blood sample is collected by the finger prick method, the needles may pinch, sting, or otherwise cause pain. The finger prick may cause excessive bleeding, a bruise or scarring. You may experience pain at the site of the finger prick test for several days after the test.

You should seek professional medical advice for interpretation of your test results and should only act on the independent information received from a medical doctor.

hs-CRP is a nonspecific indicator for a wide range of diseases. A high hs-CRP level may indicate inflammation that is not affecting your heart, especially if its level is significantly higher than normal.

Liver diseases, such as liver cirrhosis, may interfere with the HDL results. 

Other factors may interfere with the test and cause erroneous results, such as technical / procedural errors (haemolytic, lipaemic and icteric samples) or presence of interfering substances (haemoglobin, ascorbate, bilirubin, intralipid and rheumatoid factor) in the test samples.

A food sensitivity is an immune system reaction to food that may increase the IgG antibodies that are specific to that food. It may manifest into symptoms such as bloating, headaches and gastric distress. Delayed reaction may occur from hours to days after food consumption. It is important to understand that food sensitivities are different from food allergies or food intolerances. A food allergy is an immune system reaction that increases the IgE antibodies when exposed to certain foods and a food intolerance is having difficulty digesting certain foods due to an enzyme deficiency. The adverse reactions from food allergy and food intolerance are more severe and rapid. Food allergies may sometimes be life-threatening.        

Food sensitivities trigger an increased production of food specific IgG antibodies as an immune reaction. Our food sensitivity test measures your body’s IgG to a variety of common foods using TAP II blood collection device. The detection of IgG antibodies may help to identify the foods that contribute to the food sensitivity symptoms. 

An elimination diet may help to pinpoint foods that trigger the immune response. Removal of foods with high IgG levels may help relieve the symptoms of food sensitivities. 

The TAP II Blood Collection Device is a clot activator with gel separator single use device intended to be used to collect capillary blood from the upper arm of individuals for self-sample collection at home. The collected sample needs to be transported to our laboratory for analysis to determine the IgG antibody levels using immunoblotting technologies.

Food sensitivity tests can determine the immune response to certain foods. Each food will be rated on a sensitivity scale of normal, mild, moderate and high in terms of the reactivity levels of IgG antibodies. If an individual has a high IgG reactivity to certain food, the food in particular may be the cause of food sensitivity symptoms. The results may help identify foods that trigger the immune response and symptoms. 

When you are collecting the blood sample, the prick may affect healing if the prick site is already damaged. There is also a risk of infection or tissue death (a long-term effect) at the pick site. If the blood sample is collected by the TAP II device, the prick may cause an allergy reaction if you are allergic to stainless steel. If the blood sample is collected by the finger prick method, the needles may pinch, sting, or otherwise cause pain. The finger prick may cause excessive bleeding, a bruise or scarring. You may experience pain at the site of the finger prick test for several days after the test. 

IgG antibody reactivity is based on exposure to the food or foods; therefore, individuals who have recently eliminated foods from their diet may see a lower reactivity than expected.

Not all food with elevated levels of IgG reactivity will cause symptoms. You may also observe symptoms from foods with low reactivity. IgG reactivities are only one of the possible indicators of what your food sensitivities may be. 

The antibody determination indicates an individual's level of sensitivity to different foods and food additives analyzed. It does not provide information on the connection between the IgG antibody titer determined with the occurrence or severity of food allergies or food intolerances.

The test is limited by the discrete numerical values of the analysis ranging from 0 - 255, the validity and reliability of the trial data and the scope for human error in the testing protocol and there is a possibility that your test results are inaccurate.

The test may yield a false positive result(s). If the antigenic structures are similar, e.g. in chemically similar substances or due to a close botanic relationship, cross reactions between IgG antibodies of different foods and food additives may occur. 

It cannot be excluded that epitopes become inaccessible for binding to the antibodies during coating of the strips, which can result in missing signals and thus in false negatives. It is also possible that antibody binding sites are only created or become free for binding during processing or the digestion process. These cases can also cause false negative results. 

Other factors may interfere with the test and cause erroneous results, such as technical/procedural errors (haemolytic, lipaemic and icteric samples) or presence of interfering substances (haemoglobin, triglycerides and bilirubin) in the test samples.

A novel coronavirus was identified in early 2020 and was named COVID-19 virus, SARS-CoV-2. Later in the year, the rapid increase in people infected with the infectious disease led the World Health Organisation to characterise the outbreak as a pandemic. Signs and symptoms of COVID-19 can include fever, cough, shortness of breath, fatigue, headache, loss of taste or smell, and sore throat. Most people infected with the virus will experience illness ranging from the common cold to severe respiratory diseases and recover without hospitalisation. However, some will become severely ill and require medical attention. Older people and those with underlying medical conditions that have a weakened immune system are at increased risk of severe COVID-19 illness and death. 

Infection with SARS-CoV-2 initiates an immune response that produces antibodies against specific viral antigens such as the spike (S) protein. Antibodies are proteins created by the immune system that help fight off infections. They are made after one has been infected or has been vaccinated against an infection. These include antibodies that target the receptor binding domain of the spike protein’s S1 subunit. Our antibody test can detect the presence of these neutralising antibodies in blood within weeks following infection or vaccination.

Antibody tests should generally not be used to diagnose a current COVID-19 infection. However, antibodies can help prevent severe illness, hospitalizations, and death. Antibodies, whether from infection or vaccination, wane over time. How quickly antibodies wane is different for each person. Our antibody test can monitor the antibody levels.

The TAP II Blood Collection Device is a clot activator with gel separator single use device intended to be used to collect capillary blood from the upper arm of individuals for self-sample collection at home. The collected sample needs to be transported to our laboratory for analysis to determine the COVID-19 antibody levels using quantitative tests intended for assessing immune response in COVID-19.

Antibodies are developed by the body in response to an infection or after vaccination. Our antibody test looks for antibodies in your blood that fight the virus that causes COVID-19. Antibodies are for protection and often help prevent infections. It plays an instrumental role in preventing severe diseases, hospitalisations, and death. A positive antibody test indicates a person has antibodies for COVID-19 as a result of past infection or vaccination. A negative antibody test indicates antibodies to the virus were not detectable in your blood and you have not been infected or vaccinated.   

When you are collecting the blood sample, the prick may affect healing if the prick site is already damaged. There is also a risk of infection or tissue death (a long-term effect) at the prick site. If the blood sample is collected by the TAP II device, the prick may cause an allergy reaction if you are allergic to stainless steel. If the blood sample is collected by the finger prick method, the needles may pinch, sting, or otherwise cause pain. The finger prick may cause excessive bleeding, a bruise or scarring. You may experience pain at the site of the finger prick test for several days after the test.

There is a chance that this test may give a positive result when you actually don’t have antibodies and you did not have a past infection (false positive). If you inform a medical professional that you have a past infection or have antibodies based on the false-positive results, there is a chance that this could influence decisions that they make around any future care that you receive. 

There is a chance that this test may give a negative result when you actually have antibodies and you did have a past infection or vaccination, or the blood sample is collected too soon after the infection started (false negative). If you inform a medical professional that you have not been infected before based on a false negative result, there is a chance that this could influence the decisions that they make around any future care that you receive. 

You should seek professional medical advice for interpretation of your test results and should only act on the independent information received from a medical doctor.

A positive test does not mean that you cannot go on to develop the infection. It does not necessarily mean you are immune or have immunity that will prevent COVID-19. Some people with antibodies can still be infected or reinfected after recovering from a past infection. It should generally not be used to diagnose current infection and it is not recommended to assess immunity to COVID-19. 

The test is limited by the positive and negative predictive values of the analysis, the validity and reliability of the trial data and the scope for human error in the testing protocol and there is a possibility that your test results are inaccurate.

Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

Immunocompromised patients who have COVID-19 infection may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.

The persistence of a SARS-CoV-2 immune response has not been fully established. Negative results may be observed due to a decline in antibody titer over time.

Potential interference has not been evaluated for substances other than those described below: 

• Unconjugated Bilirubin 
• Conjugated Bilirubin 
• Hemoglobin 
• Triglycerides 
• Total Protein
• Acetaminophen 
• Alprazolam 
• Ascorbic Acid 
• Azithromycin 
• Biotin 
• Captopril 
• Fluoxetine 
• Guaifenesin 
• Hydroxychloroquine 
• Ibuprofen 
• Remdesivir

Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (HAMA). Such specimens may show either falsely elevated or depressed values when tested with assay kits such as SARS-CoV-2 IgG II Quant that employ mouse monoclonal antibodies.

Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed.

Rheumatoid factor (RF) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.

This Service and any Report and information provided are for informational purposes only. We do not provide diagnosis, treatment, or medical advice. You are advised to consult your healthcare provider for further advice before making decisions about your health or medical conditions, or before starting and stopping any treatment prescribed for you. 

Prenetics, its employees, contractors and agents shall have no liability to any person or entity with regards to claims, loss, or damage caused, or alleged to be caused, directly or indirectly, by the use of the information contained in the Report.

Your privacy is important to us. 

• We comply with Hong Kong laws. We comply with the applicable requirements of the Personal Data (Privacy) Ordinance in Hong Kong SAR and other applicable regulations specific to Hong Kong SAR. You understand and consent to our collection, use, processing and storage of your information, and our handling of your biological sample in accordance with Hong Kong laws and regulations, which may differ from those of your country of residence. 
• We implement physical, managerial, technical safeguards to protect your information. While we cannot guarantee that unauthorised access, disclosure, misuse or loss of information will never occur, we implement and frequently review physical, managerial, and technical safeguards to protect the confidentiality, integrity and availability of your information and to prevent information security incidents. In the event of a security incident or data breach, we will follow internal procedures to investigate the matter as well as comply with all applicable regulatory requirements. 
• Your responsibility. You are responsible for maintaining the confidentiality of your login credentials for your account and for all the activities that happen under your account. Sharing information through surveys or other features on our website is voluntary and done at your sole risk. We are not responsible for any breach of your responsibilities, which includes but is not limited to allowing others to access your account and password, or onward sharing or releasing your information publicly and you will indemnify us and our affiliates against any liability or costs arising from claims by other people based on the access and use of your account.

Further details about our policies governing customer privacy and information, including customer rights regarding such information, can be found at www.hicircle.com/privacy, or will be made available to you upon request by emailing care@hicircle.com

• To deliver test results to you. As part of the Service, you are requesting that your test results be made available to you, as may be specified in your account or order form. 
• To deliver test results and data to your healthcare provider. If you request that your test results be shared with your healthcare provider or any other third party, you consent to our provision of your test results, including any related Personal Information or Personal Health Information, to your designated healthcare provider or third party. If your ordering provider is part of a clinic or health system, Prenetics may, with your consent, provide such clinic or health system with your results, Personal Information, Personal Health Information, and related analyses, for your clinic’s or health system’s use for treatment, payment, healthcare operations, data analytics, research or other purposes, for which your clinic or health system has agreed to comply with applicable laws.  ‍
• To communicate with you. We may use your Personal Information to communicate with you about your collection kit, order, test results, account details, and other logistics and procedures in relation to the Service.

• Storing of your data. We store your Personal Information as required by applicable laws and regulations, and we may use this information to conduct subsequent testing or analysis in the event that (a) you consent to any new product or service offering, or (b) our review of medical literature and/or changes in technology indicate that such analysis is useful or necessary to confirm test results provided.
• Retention of your biological sample. We will retain your biological sample only for the duration required under applicable law or regulation (“Retention Period”), after which it will be destroyed. Until such time that your sample is destroyed, we may de-identify your sample and use or store it for regulatory and compliance purposes, internal quality control, laboratory validation studies, or, with your consent, research and development.

By using our Services or by submitting a biological sample, you confirm that:

• you have read, understood, and agree to this Informed Consent in its entirety.
• you consent to your personal information, personal health information and biological sample being processed for the purposes of the Service as described in this informed consent, terms of service and privacy notice.
• the biological sample being provided is yours and you are at least 18 years of age, or if the biological sample being provided is from someone under the age of 18 (“the minor”), you represent that: (i) the Service is permitted for the persons under the age of 18 in your country of residence, and (ii) your are the parent or legal guardian of the minor, and have the legal authority to consent for the minor. 
• you consent to the storage and use of your de-identified sample, anonymised genetic information, Personal Health Information, Personal Information and test results for internal quality control, validation studies, research and development and in Prenetics’ authored publications.  
• all information you have provided and will provide to Prenetics is true and accurate
• you understand that this Service is not available to Non-Asian Region customers under the age of 18, regardless of whether consent or permission from parents or guardians has been granted. 
• if your employer / insurer has provided or paid for (in whole or in part) the Service, you agree that your test results and Personal Health Information may be anonymized and/or aggregated and returned to your employer / insurer or its designee (e.g., plan administrator or pharmacy benefits manager) as a data analytics resource.
• you consent to being contacted for the purposes of participation in research projects. You may withdraw such consent by contacting us. 
• you consent to receiving marketing communication about products and service from Prenetics. You may withdraw such consent by contacting us. 

By using our Services or by submitting a biological sample, you understand that:

• The test results and any other information provided are not intended as a substitute for professional medical advice, help, diagnosis or treatment. You have been advised by Prenetics not to make any decisions regarding your medical care based on the test results without speaking to your healthcare provider first. Your healthcare provider remains ultimately responsible for all diagnosis and treatment decisions. 
• You understand that the Circle Terms of Service and Privacy Statement apply to the Service and are available at hicircle.com, or upon request.
• You understand and agree that your biological samples will be retained for regulatory and compliance purposes and will only be destroyed after the Retention Period