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