The aim of the study is to find the proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
Study has three study visits. First two visits are three months apart. Second and third visits are five months apart. On each study visit participant will provide venous blood sample and saliva sample obtained by gargling with the use of GARGTEST sampling kit. Participant will also fill in a questionnaire about SARS-CoV-2 infections and vaccinations. Site staff will measure the body temperature of the patient to exclude a patient with an acute infection. Blood sample will be used for the assessment of antibodies and cellular immunity of SARS-CoV-2. Part of the blood will be biobanked for the future SARS-CoV-2 biomarker determination. Gargling sample will be used for the demonstration of the pathogen on mucous membranes. Gargle self-sampling using GARGTEST sampling kit will be done by participants at 14-day intervals between the study visits. For gargle sample RT-PCR (real time polymerase chain reaction) will be done to determine the patogen presence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
2,484
Venous blood sampling three times on three visits of the study.
Gargle sampling using GARGTEST sampling kit on three visits of the study and also gargle self-sampling using GARGTEST sampling kit at 14-day intervals between the study visits.
Patient will complete questionnaire on each visit on SARS-CoV-2 infections and vaccinations
University Hospital Olomouc
Olomouc, Czechia
The proportion of people in the population of the Olomouc Region with the presence of antibodies against the SARS-CoV-2 virus
The proportion of people in the population of the Olomouc Region with the presence of IgG (or IgM) antibodies against the S and N antigens of the SARS-CoV-2 virus, therefore people who have already encountered the SARS-CoV-2 virus with manifest antibody formation, or people who have undergone vaccination against COVID-19.
Time frame: 12 months
Quantification of the level/presence of cellular immunity
Quantification of the level/presence of cellular immunity will be done from venous blood.
Time frame: 12 months
Verification of the presence of the SARS-CoV-2 virus
Verification of the presence of the SARS-CoV-2 virus on the mucous membranes of the oral cavity and pharynx using a PCR (polymerase chain reaction) test
Time frame: 12 months
Proportion of people with an asymptomatic course of SARS-CoV-2 disease
Proportion of people with an asymptomatic course of the disease - a combination of antibody tests, questionnaire surveys and data from the Institute of Health Information and Statistics of the Czech Republic will be used to assess this outcome.
Time frame: 12 months
Quantification of the presence of antibodies and the presence of cellular immunity
Quantification of the presence of antibodies and the presence of cellular immunity according to risk factors and time interval since infection/immunization
Time frame: 12 months
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Body temperature will be measured by healthcare professional at each visit to exclude patients with acute infection.