PROJECT SCREEN 知情同意書

介紹

此知情同意書會告知您服務訂單或賬戶設置所選的 2019 冠狀病毒病 (2019-nCoV) 測試（「服務」或，「2019冠狀病毒病測試」在下文進一步詳細描述）的好處、風險及限制，該測試由 Project Screen （「Project Screen」）、 Circle（「Circle」）、其母公司 Prenetics Limited， 及我們的附屬/聯營公司 —— 統稱為「Prenetics」、「我們」或「我們的」——提供。本知情同意書亦會解釋如何將您的資料及樣本與服務結合使用。此知情同意書中的「您」、「您的」、「我」及「我的」皆指為本次服務提供資料及樣本的人。如果您是進行此項服務未成年人士的父母或監護人，在此「您」也可以根據具體情況而指「您的孩子」。通過注冊，您確認您已閱讀、理解並同意此知情同意書。您了解服務是自願的而且您並非一定要使用此項服務，在使用此項服務以及同意此知情同意書之前，您（以及您的監護人或家長，如適用）可以向醫療服務提供者諮詢此項服務。請注意，所有樣本均在 Prenetics Limited 旗下獲有 ISO-15189:2012 國際認證的實驗室中進行處理。該實驗室位於香港，按國際質量標準程序處理樣本及進行基因測試，遵守包括 ISO 27001 在內的信息安全標準，並執行一系列步驟和協議，以確保患者的數據安全性。

收集的資料及用途

如果您選擇使用此項相服務，您需要提供您的個人健康資料（Personal Health Information, PHI）。為了令服務能按預期進行，您必須提供準確及正確的資料。如果由其他人代表提交您的 PHI 或相關資料，只要同意此份知情同意書，即代表您聲明並保證該人士有權代您提供該資料，且所有提供資料均準確無誤。如果您提供的是親屬的個人資料，您亦在此聲明並保證您已獲取該親屬的許可，向我們披露該資料。您也需按照我們的樣本采集程序提供深喉唾液樣本。您的樣本將被送至我們的實驗室進行處理。我們將從您提交的樣本中提取病毒核糖核酸（RNA）並進行分析。完成 2019 冠狀病毒病測試後，您將收到測試報告以查閲 2019 冠狀病毒病測試結果。建議您向醫療服務提供者諮詢了解您的檢測結果。

服務的報告

2019 冠狀病毒病測試將檢測您的身體對稱嚴重急性呼吸綜合症冠狀病毒 2 型(SARS-CoV-2)的反應 。測試結果（陽性或陰性）將會直接發送到您的電郵信箱中。

服務的風險

此服務包括一項分子測試（“2019 冠狀病毒病測試”），可能會向您透露與您的健康狀況和與 2019 冠狀病毒病有關的感染狀況等敏感信息。丟失或濫用這些信息的風險可能存在。為降低這些風險，我們實行並定期檢討一系列實質上、行政上及技術上的個人資料保護措施，以保障信息的機密性、完整性以及可用性，防止信息不安全事件。如果發生不安全事件或數據洩露，我們將按內部程序進行調查，並遵守所有適用法規要求。另外，採集深喉唾液樣本的過程可能會產生不適。未能遵循正確指引進行採樣可能會導致測試欠準確。為避免此類風險，我們提供了樣本採集教學視頻示範採樣流程。目前，該服務為直接售賣予消費者、無需醫護在場的健康服務。請注意，直接售賣予消費者的健康服務目前不受衛生署管制。在進行 2019 冠狀病毒病測試之前和之後，您可選擇諮詢醫療服務提供者。您明白並接受所涉及的風險。

 

服務的限制

2019 冠狀病毒病測試將檢測您的身體對稱嚴重急性呼吸綜合症冠狀病毒 2 型(SARS-CoV-2)的反應 （陽性或陰性）。根據實驗室測試標準和慣例，若您的初步測試結果呈陽性，Prenetics 會針對同一樣本額外進行確認性測試，以確保陽性結果屬實。如確認性測試結果均呈陽性，這表示您已被感染，並可將病毒傳染給他人。在這種情況下，茂宸晉康醫療集團的註冊醫護或您的醫療服務供應商會與您聯絡，並為您分析測試結果以及講解您需進行的步驟，包括立即進行自我隔離，以減低病毒在社區散播的風險。若果有關醫療服務提供商無法通過合理的方式，並利用您所提供的資料與您聯絡，您的報告將會被發送至您註冊使用測試服務時所提供的電郵信箱中。此外，您亦需聯絡衛生署衛生防護中心。確認性測試結果呈陽性即表示已受感染。然而，若測試結果呈陰性，在某些情況下或會屬於「假陰性」。我們列舉了一些「假陰性」情況：若測試結果呈陰性，這表示我們未有在您所提供的樣本中檢測到相關病毒。儘管如此，陰性測試結果並不完全
代表您未被 2019 冠狀病毒感染。陰性測試結果可能是因為出於感染初期，病毒的載量低，所以樣本中未能檢測到相關病毒。除此之外，陰性結果亦可能是因樣本收集程序錯誤所致。如果您的檢測結果為陰性，但仍然出現較輕微的病徵，如發燒、咳嗽和呼吸急促等，或曾與受感染人士有密切接觸，我們建議您考慮在 2-14 天潛伏期内重新收集樣本進行檢測（有報告曾指出，病毒的潛伏期可以長達 27天）。Prenetics 採用「逆轉錄——聚合酶鏈反應」（RT-PCR）作為檢測 2019 冠狀病毒病的測試方法，旨在確定您當前是否感染 2019 冠狀病毒病。請注意，RT-PCR 測試並非旨在檢測您在過去是否曾感染 2019 冠狀病毒病並由此而產生免疫。如要檢測您之前是否曾感染 2019 冠狀病毒病，可以使用抗體測試。血清學抗體快速測試既可是實驗室測試，亦可指以指尖血液作為樣本的快速測試。 一旦感染了病毒，抗體就會由我們的免疫系統中產生。此測試能夠驗出未出現任何病徵或已出現輕度病徵者有否感染 2019 冠狀病毒。此外，我們亦可以透過深喉唾液樣本測試驗出相關人士是否帶有病毒，若該測試顯示呈陽性結果，那麼結論將指出患者已被病毒感染。相反地，由於身體需要 5-8 天累積足夠抗體，抗體快速測試的結果極有可能呈陰性。總的來說，Prenetics 採樣以 RT-PCR 為基礎的檢測方法能夠檢測到當前感染患者，但無法檢測出已受感染患者。

個人私隱及數據安全

您的私隱對我們非常重要。我們遵守香港特別行政區個人資料（私隱）條例的適用規定及香港特別行政區的其他適用規例。您同意我們對未經授權洩露您的資料不承擔任何責任，除非該洩露是由於我們的重大過失或蓄意不當行為而造成。如果您居於香港特別行政區以外的地方，您應該諮詢您的醫生和/或適合的顧問，因為在某些國家，基因檢測可能會受到特定的監管限制或被禁止。同意此份知情同意書，即表示您同意按香港特別行政區法律及規例收集、使用、處理及儲存您的資料，管理該測試以及對您樣本及資料的處理，儘管條文或與您所處國家有異。您進一步同意，通過提供樣本，即代表您沒有違反您所在國家／地區的任何出口禁令或其他法律限制。我們會採取實體、管理及技術層面的保護措施，保障受保護資料的完整性及安全性。然而，我們不能保證您傳送給我們或儲存在我們網站上的任何資料的安全性。如發生數據洩露，我們會遵守所有適用的通報要求。您需要自行保障個人帳戶登入資料的私隱，並承擔其帳戶旗下的活動風險。您同意我們對未經授權洩露您的資料不承擔任何責任，除非該洩露是由於我們的重大過失或蓄意不當行為而造成，否則我們未能因您所違反的責任行為承擔任何責任，包括但不限於允許他人使用您的帳戶和密碼，或公開或共享您的個人資料，以及因他人使用帳戶而向我們和我們的關聯公司所提出的索賠。若您的測試呈陰性結果，只有你本人、為您訂購 Project Screen 的醫生，或您的視像問診醫生和 Prenetics 可以查看測試結果數據。 Prenetics 不會將數據分享予任何第三方人士或其他 Project Screen 計劃成員公司，包括英國保誠香港、雅士能基因科技、茂宸晉康醫療集團、HPA 何設計、海闊天空創投基金以及智慧物流。對於任何陽性測試結果，由於 2019 冠狀病毒是法定需申報的疾病，Prenetics 需要通知香港衛生防護中心。衛生防護中心是香港衛生署轄下的機構，負責疾病的預防和控制。該信息將用於跟踪新感染個案，以提高公眾健康意識並作出適時反應。若您的樣本測試結果呈陽性，Prenetics 將與茂宸晉康醫療集團或轉介你接受測試之醫療服務提供者分享您的測試報告以及聯絡電話，以進一步與您溝通測試結果及提供咨詢服務。另外，Prenetics 亦會與香港中文大學生物醫學學院以匿名形式分享您的樣本，中大將對該病毒樣本進行基因組測序，以確定感染源頭以及病毒株，還有其他關於病毒突變的數據。有關寄送和接收測試套裝的相關的資料，我們會與指定的物流供應商 Pickupp 分享您的姓名，地址和聯繫方式。請注意，Pickupp 是已獲衛生署批准，可在香港運送 2019 冠狀病毒病樣本的物流公司。

個人資料用途

完成 2019 冠狀病毒病測試後，您可要求我們按照您賬戶或服務訂單中的指示向您提供結果。通過同意此份知情同意書，即代表您亦同意您的分子資訊、PHI 及結果可以與您指定的任何醫療服務提供者共享。您亦同意我們可能會就您的基因採集套裝、服務訂單、結果、賬戶詳細資料，以及其他測試後勤工作及程序與您進行溝通。我們會按照適用的法律及規例要求儲存您的基因測序相關數據。我們僅會在適用法律或規例允許的最長期限（「保留期」）內保留樣本，並於其後將之銷毀。在您的樣本被銷毀之前，我們可能將您的樣本去識別化，使用或儲存，以于監管、內部質量控制、實驗室驗證，或在您的知情同意下用作進行科技研發。您的基因資訊、PHI、個人數據及測試結果也可能去識別、儲存、並用於內部質量控制、驗證、科技研發，或我們著作的出版物當中，而出版物可以是由我們自己出版，或與第三方學術或商業機構合作出版。

同意

我所提供的樣本是屬於本人的，而我已年滿 18 歲；或如果我是代表其他人表示同意的話，我有法定權力為提供樣本的人表示同意。如果提供的樣本來自 18 歲以下人士，我在此表明我是測試者的父母或法定監護人。報告的結果及資料不構成 Prenetics 的醫療建議。我不應該根據這些結果，在未經諮詢我的醫療服務提供者的情況下，作出任何醫療決定或更改用藥。我的醫療服務提供者仍然負責我的所有診斷及治療決定。我的樣本以及我所有相關的個人資料將被送至Prenetics 分析、使用、處理及儲存，並受香港特別行政區的法律、法例及規例約束。所有樣本將在適用的保留期結束後銷毀。我同意 Project Screen 的服務條款及私隱政策，其文本可在 projectscreen.co 上獲得或按要求提供。我確認所提供的所有資料皆真實準確。我同意我有權提供此同意書。我明白如果我想撤回此同意書，我可以聯繫 Project Screen。我已閱讀並理解此知情同意書內所提供的資訊。

 

PROJECT SCREEN INFORMED CONSENT

Introduction

This Informed Consent reviews the benefits, risks and limitations of undergoing COVID-19 (2019-nCoV) testing as selected on your order form or in your account settings (“Service(s)”, or “COVID-19 Test(s)”, as described in further detail below) provided through Project Screen (“Project Screen”), Circle (“Circle”), Prenetics Limited, and our affiliated companies, collectively referred to as “Prenetics”, “we”, “us”, or “our”. It also explains how your information and sample will be used in connection with the Service. Throughout this Informed Consent, “you”, “your”, “me”, “my”, and “I” refer to the person whose information and sample is being provided for this Test. If you are a parent or guardian requesting a Test for a minor (as permitted by the TOS depending on your country of residence), “you” may also refer to “your child”, as contextually appropriate. By proceeding with the registration, you confirm and acknowledge that you have read, understood, and agreed to this Informed Consent. You understand that the Service is voluntary and that you are not required to have the Service. Prior to proceeding with the Service and thereby agreeing to this Informed Consent, you (and your guardian or parent, as appropriate) may wish to speak with a healthcare provider about the Service. Please note that the laboratory which is performing the COVID-19 test is Prenetics Limited. Prenetics is a ISO-15189:2012 laboratory based in Hong Kong and adheres to international and industry standards, including ISO 27001 Information Security Standards, and administers a number of steps and protocols to ensure that your data remains safe and secure.

 

What we collect and how it is used

If you request a Service, you will be asked to provide your Personal Health Information (PHI). In order for the Service to perform as intended, you must provide accurate and correct information. If another person is submitting your PHI or related 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. If you are providing personal information about your relatives, you also represent and warrant that you have obtained permission from such relatives to disclose such information to us. You will be asked to provide a deep throat saliva sample in accordance with our collection procedures. Your sample will be transferred to our laboratory. Viral RNA will be extracted from the submitted sample and analyzed. Upon successful completion of a COVID-19 Test, a report will be made available to you which will show the results of the COVID-19 test. It is advisable that you speak to your healthcare provider.

Results of the Service

The COVID-19 Test will tell you if you are positive or negative for SARS-CoV-2 – the coronavirus that causes COVID-19. Your results will be sent digitally to the email address we have on file.

Risks of the Service

The Service includes a molecular test (“COVID-19 Test”) that may reveal to you 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. Additionally, collection of a deep throat saliva sample may produce discomfort. Some may not be able to follow the appropriate procedure which could result in sub-optimal results. To mitigate this risk, we have provided simple instructional videos illustrating the procedures. At this time, the service is being offered as a direct to consumer health service without the need to see a physician. Please do note that direct to consumer health service is not currently regulated by the Department of Health. You may elect to consult with your healthcare provider before and after performing the COVID-19 test. You understand the risks involved and accept the risk.

Limitations of the Services

The COVID-19 Test will tell you if you are positive or negative for SARS-CoV-2 – the coronavirus that causes COVID-19. According to standard lab testing protocols, positive results will undergo a second test with the same sample to confirm its status. A positive result means that you are infected with the disease and are potentially contagious. Those with positive results will be notified via a telephone consultation with a Hong Kong-registered health professional from Mason Supreme Healthcare or from the physician which has ordered your test on your behalf, they will outline the results and provide appropriate next steps. In the event that you are not reachable via your contact information after reasonable attempts, your report will be sent directly to your registered email address. Individuals who test positive will be instructed to immediately selfisolate to limit the risk of exposure to the community, and to contact the Centre for Health Protection in Hong Kong to receive proper care. 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. If you are tested negative and have mild symptoms such as a fever, cough, shortness of breath, and/or have had close contact with an infected individual, you may want to consider getting re-tested within the 2-14 days incubation period (longer incubation periods of up to 27 days have also been previously reported). Prenetics utilizes RT-PCR as the testing methodology to detect COVID-19 and is intended to identify if you are currently infected with COVID-19. Please note that the RT-PCR test is not intended to detect if you have had COVID-19 in the past and may be immune from it. To detect if you may have been infected previously with COVID-19, this would be with an antibody test. Serology antibody rapid tests are either a laboratory test or a finger-prick rapid test that uses your blood as the specimen type. Antibodies are generated by our immune system when we have contracted a virus. As there are individuals who may have contracted SARS-CoV-2 – but with no or only have mild symptoms – antibody testing can tell if you have been previously infected as antibodies for the said-virus would be in your system. Therefore, if the RT-PCR of the deep throat saliva shows the presence of the virus, it can be concluded that a patient is COVID-19 positive (and therefore infected). However, the antibody test of the same patient will most likely be negative, as COVID-19 antibodies take a duration of 5-8 days to be in sufficient quantities and to be detected. In summary, the Prenetics RT-PCR test can detect current infections but cannot detect previous infections.

Privacy and data security

Your privacy is important to us. 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. By agreeing to this Informed Consent you acknowledge that such laws and regulations regarding collection, use, processing, and storage of your Information shall govern our performance of the Service and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any law or other legal restriction.While we cannot guarantee that unauthorised access, disclosure, misuse or loss of Information will never occur, 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. You are responsible for maintaining the confidentiality of your login credentials for your account and you are
responsible for all the activities that happen under your password and account. Sharing Self-Reported Information through surveys, or other features on our website, is voluntary and done at your sole risk. Unless due to gross negligence or misconduct on our part, we cannot take responsibility for any breach of your responsibilities, which includes but not limited to allowing others to access your account and password, or onwardly sharing or releasing publicly your Information 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. The only parties who would have access to your test results data (negative results) would be yourself, your physician who ordered Project Screen for you, your Telehealth Consultation physician and Prenetics – i.e. the testing party. Prenetics does not share the data with any third party or any other member of the companies involved in the Project Screen consortium, including Prudential Hong Kong, Xcelom, Mason Supreme Healthcare, hpa SOCIAL, Beyond Ventures, and Pickupp. For data pertaining to any positive test results, Prenetics would need to notify the Hong Kong Centre for Health Protection as COVID-19 is deemed a statutory notifiable disease. The Centre for Health Protection is an agency under the Department of Health in Hong Kong responsible for disease prevention and control. The information would be used to track new infections for the purpose of public health awareness and response. Additionally, for any positive test results, Prenetics will share the test report and contact number to a designated healthcare professional at Mason Supreme Healthcare or the physician which has ordered your test on your behalf, in order to notify you of your results through telephone consultation. Further, Prenetics will provide the physical sample – that has been anonymised – to Chinese University of Hong Kong Biomedical Sciences department who will sequence the genome of the virus to identify its strain, which could be used to pinpoint the source of infection and also provide important information about how the virus may be mutating. For information relating to the fulfilment of delivering and receiving the test kits from you, we do share your name, address and contact details with Pickupp, our designated logistics provider. Please note that Pickupp is approved by the Department of Health for the logistics of COVID-19 samples in Hong Kong.

Use of your information

Upon completion of COVID-19 Test, you are requesting that your results be made available to you as specified in your account or order form. By agreeing to this Informed Consent, you also agree that your molecular information, PHI, and results can be shared with any healthcare provider that you designate. You also agree that we may communicate with you about your collection kit, order, results, account details, and other test logistics and procedures. We store your molecular data as required by applicable laws and regulations. We will retain the sample only for the maximum duration permitted under applicable law or regulation (“Retention Period”), after which point 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 compliance purposes; internal quality control; laboratory validation studies; or, with your consent, research and development. With your consent, your information, PHI, personal data, and results may also be de-identified, stored and used for internal quality control; validation studies; and in publications authored by us, either on our own or in collaboration with academic third parties.

 

Consent

The sample being provided is mine and I am at least 18 years of age, or if consenting for someone else, I have the legal authority to consent for such a person whose sample is being provided. If the sample being provided is from someone under the age of 18, I represent that I am the parent or legal guardian of the person being tested. The reported results and information do not constitute medical advice by Prenetics. I should not make any medical decisions or medication changes based on these results without speaking to my healthcare provider first. My healthcare provider remains ultimately responsible for all diagnosis and treatment decisions. My sample and all my related personal information will be transferred to Prenetics for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the Hong Kong SAR. All samples will be destroyed after the end of the applicable Retention Period. I agree to the Project Screen Terms of Service and Privacy Statement, which are available at projectscreen.co or upon request. I confirm that all information provided is true and accurate. I agree that I have the authority to provide this consent. I understand that if I wish to withdraw consent, I may do so by contacting Project Screen. I have read and understood the information provided in this Informed Consent.