Participant Information Sheet

Short Title

Orbis Immunity for COVID-19 (QIC) Test Sensitivity and Specificity Study

Protocol Number

ORB-003

Project Sponsor

Orbis Diagnostics Limited, 125 Queen Street, Auckland, 1010

Principal Investigator

Dr Api Talemaitoga 

Locations

Air NZ Campus, 5 Geoffrey Roberts Road, Mangere, Auckland, 2022

Auckland Airport Domestic Terminal - Air NZ Jet and Turboprop Crew Rooms

Southern Clinical Trials Manukau, Cavendish Doctors, 175 Cavendish Drive, Manukau, Auckland 2104

Ethics Number

21/NTB/212

This is one of the first clinical trials of the Orbis QIC test in people.

You may not get any health benefit from the study device; but there are risks of you having a device-related injury.

You are invited to take part in a study involving an investigational device. This Participant Information Sheet will help you decide if you’d like to take part. It sets out why we are doing the study, what your participation would involve, what the benefits and risks to you might be, and what would happen after the study ends. Whether or not you take part is your choice.  If you do not want to take part, you do not have to give a reason, and it will not affect the care you receive.  If you want to take part now, but change your mind later, you can pull out of the study at any time.

We will go through this information with you and answer any questions you may have. You do not have to decide today whether or not you will participate in this study. Before you decide you may want to talk about the study with other people, such as family, whānau, friends, or healthcare providers. Feel free to do this.

If you agree to take part in this study, you will be asked to sign the Consent Form on the last page of this document. You will be given a copy of both the Participant Information Sheet and the Consent Form to keep. This document is 10 pages long, including the Consent Form. Please make sure you have read and understood all the pages.

Voluntary Participation and Withdrawal From This Study

Taking part in this study is voluntary (your choice). You are free to say yes or no.  If you do take part, you are free to change your mind and withdraw at any time without penalty or loss of benefits to which you are otherwise entitled and without having to give a reason. If you wish to leave the study, tell a member of the study staff. No judgement will be shown toward you regarding medical care or participation in future research.

What is the purpose of the study?

The Orbis QIC test is being developed as a rapid tool to assess an individual’s immune response to COVID-19 from a single finger prick of blood. This information may allow people to move around more freely if the risk of COVID-19 infection is known to be low, such as quarantine free travel for those with sufficient immunity. When a person is infected with a virus or they are fully vaccinated, most people will have an immune response. This means that cells in their body produce antibodies so that if that person is exposed to the virus again, their body is able to fight the infection and prevent them from becoming sick. If a person has neutralising IgG antibodies that target SARS-CoV-2 (the virus that causes COVID-19) circulating in their blood, this shows that the person has had a rapid and effective immune response that could prevent COVID-19 infection. By measuring the amount of IgG antibodies in a person who is thought to be immune to SARS-CoV-2 through vaccination, will provide a reliable and accurate test to determine their ability, or inability to become infected. The Orbis QIC test cannot be used to diagnose or exclude acute SARS-CoV-2 infection and at this time, it is currently unknown for how long antibodies remain in your blood following infection.

The aim of this study is to test the Orbis QIC test device’s ability to:

  • Detect IgG antibodies in individuals who have received the COVID-19 vaccine
  • Correctly identify individuals who have not received the COVID-19 vaccine
  • Repeatedly produce the same results

You have been invited to take part in this study as you work for an airline or are a member of the public and are one of the groups of people for which this device could be used in the future.

How is the study designed?

A total of 175 participants will be enrolled into the study - 75 unvaccinated and 100 vaccinated individuals.  

The study will involve one clinic visit during which the following procedures will take place:

  • Informed consent process
  • Collection of demographic information including your age, gender and ethnicity
  • Collection of COVID-19 vaccination status and date of vaccination, if applicable
  • Collection of the date and result of your most recent PCR test
  • Finger prick blood sample collection
Who can take part in the study?
To take part in this study, you must be:
  • 18-65 years of age
  • In generally good health
  • If vaccinated:

–  Confirmation of being fully vaccinated against SARS-Cov-2 infection at least 7 days before blood collection

–  Have received both doses of the Pfizer-BioNTech vaccine through the New Zealand COVID-19 vaccination program

  • Be willing to provide consent to participate in the study
You cannot take part in this study if you:
  • Have any medical condition which theInvestigator thinks might mean it is not safe for you to take part
  • Are currently being treated for or are known to have symptoms associated with COVID-19
  • Know you are pregnant
  • Have previously had a confirmed or suspected COVID-19 infection
What will my participation in the study involve?

You can participate in this study by attending one of the walk-in clinics or by pre-booking an appointment with the study team. For those participants who attend a pre-booked appointment you may be asked to provide an additional finger prick sample as outlined in the section below.

The study will involve one clinic visit, which will take up to 30 minutes, and will include the following:

  • Informed consent process – you will be given this Information Sheet to read and will be provided with the opportunity to discuss the study with one of the study team.  They will be able to answer any questions that you may have. If you decide to take part, you will be asked to sign the consent form at the end of the Information Sheet to confirm that you understand the information you have been given and voluntarily agree to take part. You are welcome to discuss the study with your family / whānau / friends or your regular doctor to help you decide if you would like to take part or not.
  • Demographic information – the study team will collect your personal information including your name, age, gender and ethnicity.
  • Vaccination status – by signing this consent form you agree to the study team obtaining information regarding the date and type of your COVID-19 vaccination from the Ministry of Health COVID-19 Immunisation Register.  
  • PCR results - the study team will collect the date and result of your most recent PCR test.
  • Finger prick blood sample – a device called a lancet will be used to prick your fingertip. Your finger will then be squeezed until enough blood has come out to collect a sample. A small pipette will be used to collect one droplet (approximately 30mcl) of blood from your finger and transfer it to the testing vial. Participants attending a pre-booked appointment may be asked to provide an additional droplet (approximately 30mcl) of blood for testing. The testing vial will be placed in a rack which will be shipped to the Sponsor's laboratory for testing.  

There is the possibility that the results of your Orbis QIC test will differ from what is expected. For example, if you are expecting a negative test result because you are unvaccinated and have not tested positive for COVID-19 in the past, but instead you receive a positive test result, meaning that there are antibodies to SARS-CoV-2 detected in your blood. In this instance you will be given the option of a follow up test using an approved laboratory-based antibody test to confirm if there was an error with the Orbis QIC test result.

What will happen to my blood samples?

The sample collected from your fingertip will be tested in the Sponsor's laboratory (within New Zealand) within 48 hours of collection. Your sample will be labelled with your participant code, not your name or any other identifying information. Only the study team will be able to identify you from this code. Any remaining sample will be destroyed shortly after testing. Your blood sample will not be used for any genetic or future testing.

We understand that Māori may consider blood to be tapu, and that participation in this type of study requires careful consideration. Some of your information will be the same as your whānau, and when donating a blood sample it may be appropriate to discuss participation with them. You may also wish to consult your iwi for participation in this research.  

Should you have any concerns regarding appropriate practice/tikanga to address cultural issues arising from your participation in the study, talk to your whānau, someone you respect in your community or contact Henare Johnson, Manager Māori Projects at Air NZ (henare.johnson@airnz.co.nz) or Buddy Mikaere (buddy@buddymikaere.com).  We respect the importance of these values and beliefs.

What are the possible risks of this study?

 Below are the possible risks of taking part in this study:

  • Blood sample collection – the lancet device used to collect the blood sample may cause discomfort or result in bruising.
  • Allergic reaction – you may experience an allergic reaction to the gloves used by the study team in this study. Please inform the study team before the sample collection if you have a known allergy to latex. Latex allergies occur in approximately 4% of the world’s population. Symptoms of an allergic reaction may include itching, redness, hives, rashes, blisters, sneezing, runny nose, itchy or watery eyes, scratchy throat, difficulty breathing, wheezing or a cough.
What are the possible benefits of this study?

There are no direct benefits to you taking part in this study. However, the information gathered from this study will be used to further develop the device with the aim that in future it can be used as a screening tool for COVID-19 immunity. This test is intended to support border authorities to make informed, individualized containment decisions for international arrivals that ultimately enables an increase in volume of air travel with minimal risk to border security.

What are my responsibilities?

If you decide to take part in this study you must provide truthful information to all questions asked by the study team including, your health and any COVID-19 symptoms you may have, your vaccination status and whether you might be pregnant (for women of child-bearing potential). You should also notify the study team via the contact details on this form if you experience any adverse effects up to 7 days after your visit. They will provide advice on how best to manage these effects.

What are the alternatives to taking part?

Since this study is not intended to provide treatment or other health-related benefits, your alternative is not to participate in the study.

Will any costs be reimbursed?

You will be provided with $75 cash to thank you for participating in this study. There are no anticipated costs associated with taking part in this study.

What if something goes wrong?

If you were injured in this study, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery.

Orbis Diagnostics Limited has also satisfied the New Zealand Government’s Health and Disability Ethics Committee (https://ethics.health.govt.nz) that approved this study that it has up-to-date insurance for providing participants with compensation if they are injured as a result of taking part in this study.

New Zealand ethical standards require compensation for injury to be at least ACC equivalent. Compensation should be appropriate to the nature, severity and persistence of your injury and should be no less than would be awarded for similar injuries by New Zealand’s ACC scheme.

An initial decision whether to compensate you would be made the by the Sponsor and/or its insurers.  

If they decide not to compensate you, you may be able to take action through the Courts for compensation, but it could be expensive and lengthy, and you might require legal representation. You would need to be able to show that your injury was caused by participation in the trial.

If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.

What will happen to my information?

During this study the study staff will record information about you and your study participation. This includes your age, gender, ethnicity, vaccination status, PCR results and the results of your finger prick blood test.

Identifiable Information

Identifiable information is any data that could identify you (e.g. your name, date of birth, or address). The following groups may have access to your identifiable information:

  • Study staff (to complete study assessments)
  • Study monitors, to make sure the study is being run properly and that the data collected is accurate.
  • The Sponsor and its representatives if you make a compensation claim for study-related injury. Identifiable information is required in order to assess your claim.
  • The Sponsor, ethics committees, or government agencies from New Zealand or overseas, if the study or site is audited. Audits are done to make sure that participants are protected, the study is run properly, and the data collected are correct.
  • Your usual doctor, if a study test gives an unexpected result that could be important for your health. This allows appropriate follow-up to be arranged. For example, if you are unvaccinated and are not aware of any previous infection with SARS-CoV-2 but are found to have IgG antibodies, the study team may refer you to have a laboratory blood test to confirm if the result is correct.
  • The Ministry of Health, if an unvaccinated participant has a positive test result as this would indicate prior infection with COVID-19. In this instance, you would first be offered a follow up laboratory blood test to confirm the result is correct.
De-identified (Coded) Information

To make sure your personal information is kept confidential, information that identifies you will not be included in any study information sent to or generated by the Sponsor. Instead, you will be identified by a code. Dr Awill keep a list linking your code with your name, so that you can be identified by your coded data if needed.

The following groups may have access to your coded information:

  • The Sponsor, for the purposes of this study.
  • People and companies working with or for the Sponsor, for the purposes of this study (this may include approximately 20 people).  
  • Regulatory or other governmental agencies worldwide.

The results of the study may be published or presented, but not in a form that would reasonably be expected to identify you.

Security and Storage of Your Information

Your identifiable information is held at Southern Clinical Trials Manukau during the study. After the study it is transferred to a secure archiving site and stored for at least 10 years, then destroyed. Your coded information will be entered into electronic case report forms and sent through a secure server to the Sponsor. Coded study information will be kept by the Sponsor in secure, cloud-based storage indefinitely. All storage will comply with local and/or international data security guidelines.

Risks

Your study records will be kept as confidential as possible. Although efforts will be made to protect your privacy, absolute confidentiality of your information cannot be guaranteed. Even with coded or anonymised information, there is no guarantee that you cannot be identified. The risk of people accessing and misusing your information (e.g. making it harder for you to get or keep a job or health insurance) is currently very small, but may increase in the future as people find new ways of tracing information.

Rights to Access Your Information

You have the right to request access to your information held by the research team, including the outcome of the Orbis QIC test. You also have the right to request that any information you disagree with is corrected.  

If you have any questions about the collection and use of information about you, you should ask Dr.

Rights to Withdraw Your Information

You may withdraw your consent for the collection and use of your information at any time, by informing a member of the study team.  

If you withdraw your consent, your study participation will end, and the study team will stop collecting information from you.

Information collected up until your withdrawal from the study will continue to be used and included in the study. This is to protect the quality of the study.

Ownership Rights

Information from this study may lead to discoveries and inventions or the development of a commercial product. The rights to these will belong to the study Sponsor. You and your family will not receive any financial benefits or compensation, nor have any rights in any developments, inventions, or other discoveries that might come from this information.

Māori Consultation and Data Sovereignty

Personal and health information is tāonga and will be treated accordingly.  The data sovereignty principles of whakapapa, whanaugatanga, rangatiratanga, kotahitanga, manaakitanga and kaitiakitantga will be considered throughout the study. This will help make sure that information from this research is protected and can benefit Māori now and in the future.

Can I find out the results of the study?

The results of the study may be published or presented, but not in a way that would reasonably be expected to identify you. You will receive a summary of the study results. This summary will be sent to you once the final study report is available (this can take 2-4 months). A description of this trial will also be available on the www.anzctr.org.au website. This website will not include information that can identify you. At most, it will include a summary of the study results.

Who is funding the study?

Orbis Diagnostics Limited, a medical device company based in New Zealand, is funding this clinical study. Orbis is the ‘Sponsor’ of the study, which means it has overall responsibility for developing, managing, and conducting the study. Southern Clinical Trials Manukau are paid by Orbis to do this study.   

Who has approved the study?

This study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. The Northern B Health and Disability Ethics Committee has approved this study.

Who do I contact for more information or if I have concerns?

If you have any questions, concerns or complaints about the study at any stage, you can contact:

Name:             Dr Api Talemaitoga, Principal Investigator
Phone:            (09) 8699963
Email:              a.talemaitoga@xtra.co.nz

If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on:

Phone:            0800 555 050
Fax:                 0800 2 SUPPORT (08002787 7678)
Email:              advocacy@advocacy.org.nz

Website:          https://www.advocacy.org.nz/

 

For Māori health support please contact:

Henare Johnson, Manager Māori Projects atAir NZ

Email:              henare.johnson@airnz.co.nz  

Buddy Mikaere

Phone:             021 384 620

Email:               buddy@buddymikaere.com

 

You can also contact the health and disability ethics committee (HDEC) that approved this study on:

Phone:            0800 4 ETHIC

Email:              hdecs@health.govt.nz