None listed
Conditions
Brief summary
The Herekorenga - Freedom study is recruiting approximately 300 participants to take part from a variety of different backgrounds. Participants will be categorised into three (3) main groups for sample data analysis based on information given in the participant questionnaire: I. People who have been infected with COVID-19 II. People who have been vaccinated (one (1) or two (2) doses) III. People who have not been infected with COVID-19 and have not been vaccinated Participants will be required to attend the designated Tend Medical Clinical at a pre-arranged time, where all documentation such as the questionnaire and consent form will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study - a similar amount as a doctor would take during a routine blood test. This will be the only time a sample will be required for this study. These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis. This allows the analysis to be conducted under blinded study conditions. IGENZ will also run the Rako SARS-CoV-2 saliva test for each patient to ensure there are no unknown active infections. Positive and negative controls will be included in each assay run. These controls will be run as separate samples alongside the patient samples. The PictArray™ SARS-CoV-2 IgG ELISA also includes internal controls (alignment spots) to monitor system performance during each run. Validity of each clinical sample will be determined by the result of both external and internal controls.
Interventions
Participants will be required to attend the designated Tend Medical Clinic (in Auckland) at a pre-arranged time, where all documentation such as the questionnaire and PISCF will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study. This will be the only time a sample from participants
Participants will be required to attend the designated Tend Medical Clinic (in Auckland) at a pre-arranged time, where all documentation such as the questionnaire and PISCF will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study. This will be the only time a sample from participants will be taken for this study. It is estimated participants will require 20 - 30 minutes to complete documentation and sample collection. These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis of the samples on the PictArray™ SARS-CoV-2 IgG Enzyme linked immunosorbent assay (ELISA) . This allows the analysis to be conducted under blinded study conditions. Pictor will then receive the data from the samples for further statistical analysis. A report detailing the presence or absence of antibodies towards the COVID-19 virus spike and nucleocapsid proteins will be compiled using this analysis.
Sponsors
Pictor
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participation by people of all genders, ages and ethnicities is encouraged in this study. Pictor would like to get a representative selection of Aotearoa New Zealand’s unique population. We are especially encouraging people who fall into the following categories to become involved in this study. I. People who have been infected with COVID-19 II. People who have been vaccinated (one (1) or two (2) doses) III. People who have not been infected with COVID-19 and have not been vaccinated
Exclusion criteria
I. Participant has not given consent to use of their sample II. The sample was not properly collected, labelled, transported, processed or stored according to instructions provided by Pictor to the independent laboratory.
Outcome results
None listed