None listed
Conditions
Brief summary
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. In future, this information may allow people to move around more freely if their risk of COVID-19 infection is known to be low, such as quarantine free travel for those with sufficient immunity. 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
Interventions
Interventional.
This is a Phase I, single-site study to test the sensitivity, specificity and reproducibility of the Orbis QIC Test in vaccinated and un-vaccinated participants.
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. 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.
Interventional. This is a Phase I, single-site study to test the sensitivity, specificity and reproducibility of the Orbis QIC Test in vaccinated and un-vaccinated participants. 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. 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. The study will involve participants individually attending one clinic visit of approximately 30 minutes during which the following procedures will take place: - Informed consent process - Collection of demographic information including age, gender and ethnicity - Collection of COVID-19 vaccination status and date of vaccination, if applicable - Collection of the date and result of the participants most recent PCR test - Two Finger prick blood samples will be collected The study will be run at the airline's facility with the support of a private research study team. All members of the study team are appropriately qualified by education, training and experience suitable to their role in the study. The Orbis Arca device on which the QIC Test is run will be operated by trained Orbis personnel.
Sponsors
Orbis Diagnostics Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female airline staff, 18-65 (inclusive) years of age. 2. Is in generally good health with no underlying conditions that would be considered to present a risk to the participant or data integrity. 3. For vaccinated airline staff, the participant: - Is able to provide documentation of being fully vaccinated for SARS-CoV-2 infection at least 7 days prior to Day 1. - Received the Pfizer-BioNTech COVID-19 vaccine through the New Zealand vaccination pregame 4. Is willing to provide consent to participate in the study.
Exclusion criteria
1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data. 2. Currently being treated for or are known to be not completely free of symptoms associated with SARS-CoV-2 infection. 3. Known to be pregnant. 4. Partially vaccinated person (i.e. having received only one of the two vaccine doses) 5. For un-vaccinated participants, no previous confirmed or suspected SARS-CoV-2 infection, as determined by positive PCR, antigen, or antibody test, or by the determination of a government health agency.
Outcome results
None listed