Project Screen Informed Consent

Introduction

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 the COVID-19 test which you have selected (the “Service”).

This Informed Consent:

reviews the benefits, risks and limitations of the Service which you have selected;
explains how your personal information, personal health information, laboratory results, and/or biological sample will be used in connection with the Service;
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;
seeks your consent to receiving direct marketing materials; and
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”, 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.
Recording of your interaction with our representatives. If you interact with our representatives as part of our Service, your interaction will be recorded in order for us to provide the Services, and for internal quality control purposes.
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, and follow any guidelines or instructions that we provide.
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 our Services may not be completed 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.

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

Description of the Service

The At-Home (Virtual) COVID-19 Rapid Antigen Test is a self-administered test virtually supervised and validated by trained professionals. After taking the At-Home (Virtual) COVID-19 Rapid Antigen Test and uploading the result to your account on web.prenetics.com, a trained professional will issue a certified digital result. A negative test result can be used for international travel to destinations that accept Rapid Antigen Test as entry requirement.
The COVID-19 Rapid RT-PCR Test involves a deep throat saliva sample taken at-home or a combined nasal and throat swab sample collected in-person by a trained health professional. The sample is processed in Prenetics’ ISO-15189:2012 laboratory based in Hong Kong. Prenetics’ laboratory will issue a certified digital result. A negative test result can be used for international travel to destinations that accept RT-PCR Test as entry requirement
The COVID-19 Rapid Antigen Test is a nasal swab collection performed by a trained health professional and analysed using Flowflex™ COVID-19 Rapid Antigen Test. The COVID-19 Rapid Antigen Test will be conducted at Hong Kong International Airport and Prenetics will issue a certified digital report via SMS and email. A negative test result can be used for international travel to destinations that accept Rapid Antigen Test as entry requirement.

Risks of the Services

For the At-Home (Virtual) COVID-19 Rapid Antigen Test you will collect your own sample in accordance with the instructions manual provided with the relevant Rapid Antigen Test. The collection of a Sample may produce discomfort, irritation, bleeding, and, in rare cases, infection inside the nose where the nasal sample was collected.
For the COVID-19 Rapid RT-PCR Test conducted at the Hong Kong international airport, a trained professional will collect your sample. The collection of a Sample may produce discomfort, irritation, bleeding, and, in rare cases, infection inside the nose where the nasal sample was collected.
For the COVID-19 Rapid Antigen Test a trained professional will collect your sample. The collection of a Sample may produce discomfort, irritation, bleeding, and, in rare cases, infection inside the nose where the nasal sample was collected.
If, for any reason, the Sample is improperly collected or handled, you may not receive a valid result, or the results may be false.
The Test may reveal sensitive information about your health and state of infection with respect to COVID-19 virus. There is a potential risk of loss or misuse of this information. To mitigate this risk, we implement and frequently review certain physical, managerial, and technical safeguards that are designed 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.

Limitations of the Services

The At-Home (Virtual) COVID-19 Rapid Antigen Test will tell you if the COVID-19 viral surface protein is present inside nasal samples. A positive result means that the Sample you have provided highly likely contains COVID-19 viral surface protein and that you are most likely to be infected with COVID-19 and are potentially contagious. Individuals who receive a positive result should seek immediate medical attention. The clinical case for positive results is very straight-forward. However, for negative results, there will be scenarios where it may produce false-negatives. Below we outline such scenarios. For those with negative results, it means that the virus was not detected in the sample at the time of the test. A negative result does not mean that you do not have COVID-19. If it’s negative, it may be because it is still too early in the infection stage, where the viral load in the nasal sample may be so low that it is not detected. A negative result could also be due to your sample not being collected properly.
The COVID-19 Rapid RT-PCR Test will tell you if SARS-CoV-2 RNA, the virus that causes COVID-19, is detected in your Sample. According to standard lab testing protocols, if a sample returns a positive result, a second test will be carried out with the same sample to confirm its status. A positive result means that the Sample you have provided contains SARS-CoV-2 RNA and that you are likely to be infected with COVID-19 and are potentially contagious. Individuals who receive a positive result should seek immediate medical attention. The clinical case for positive results is very straight-forward. However, for negative results, there will be scenarios where it may produce false-negatives. Below we outline such scenarios. For those with negative results, it means that the virus was not detected in the sample at the time of the laboratory test. A negative result does not mean that you do not have COVID-19. If it’s negative, it may be because it is still too early in the infection stage, where the viral load may be so low that it is not detected. A negative result could also be due to your sample not being collected properly.
The COVID-19 Rapid Antigen Test will tell you if the COVID-19 viral surface protein is present inside nasal samples. A positive result means that the Sample you have provided highly likely contains COVID-19 viral surface protein and that you are most likely to be infected with COVID-19 and are potentially contagious. Individuals who receive a positive result should seek immediate medical attention. The clinical case for positive results is very straight-forward. However, for negative results, there will be scenarios where it may produce false-negatives. Below we outline such scenarios. For those with negative results, it means that the virus was not detected in the sample at the time of the test. A negative result does not mean that you do not have COVID-19. If it’s negative, it may be because it is still too early in the infection stage, where the viral load in the nasal sample may be so low that it is not detected. A negative result could also be due to your sample not being collected properly.

Informational Purposes Only

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 and 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 information contained in the Report.

Privacy and data security

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 onwardly 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, will be made available to you upon request by emailing privacy@prenetics.com.

Use of your information

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.

Retention of your information

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.

Representations and Consent

By using our Services, you confirm that:

you have read, understood, and agree to this Informed Consent in its entirety.
you consent to your personal information and sample being processed for the purposes of the Service as described in this informed consent, terms of service and privacy notice.
all information you have provided and will provide to Prenetics is true and accurate
you consent to receiving marketing communication about products and service from Prenetics. You may withdraw such consent by contacting us.

By using our Services, 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 Project Screen Terms of Service and Privacy Statement apply to the Service and are available at projectscreen.co, or upon request.