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The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that were randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution.
The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously.
The investigators are using a direct detection of SARS-CoV-2 RNA in nasopharyngeal samples with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay.
The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that we have randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution.
The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously.
Direct detection of SARS-CoV-2 RNA in nasopharyngeal samples is performed with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay.
Principal aims of the study are to systematically and accurately assess:
The study is carried out by the Institute of Microbiology and Immunology of University of Ljubljana. The Institute is Slovenia's leading institution for microbiology and immunology research. The study is joined by a team of IT specialists, data scientists, and statisticians from the other departments of the University of Ljubljana.
To speed-up and support the study, an innovative information infrastructure for data gathering and management was purposely developed and optimized for the study. The system fosters error-free data collection, automatic processing of questionnaires using artificial intelligence approaches, and provides security for sensitive clinical data.
All participants will be passively followed up twice monthly and tested again for the presence of anti-SARS-CoV-2 antibodies in plasma samples six months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General cohort | General population cohort aged 0-100 years from Slovenia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO intervention planned due to the observational study design - only a diagnostic testing | Diagnostic Test | Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples | Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples | April to May 2020 |
| Prevalence of anti-SARS-CoV-2 antibodies in blood samples | Prevalence of anti-SARS-CoV-2 antibodies in blood samples | April to November 2020 |
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Inclusion Criteria:
Signed informed consent only.
Exclusion Criteria:
Declined participation, no response on study invitation, no samples collected.
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3,000 inhabitants randomly selected from the Slovenian general population. Sample is representative in age, gender, and geographical distribution.
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| Name | Affiliation | Role |
|---|---|---|
| Mario Poljak, MD | Univesity of Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32688068 | Result | Maver Vodicar P, Ostrbenk Valencak A, Zupan B, Avsic Zupanc T, Kurdija S, Korva M, Petrovec M, Demsar J, Knap N, Strumbelj E, Vehovar V, Poljak M. Low prevalence of active COVID-19 in Slovenia: a nationwide population study of a probability-based sample. Clin Microbiol Infect. 2020 Nov;26(11):1514-1519. doi: 10.1016/j.cmi.2020.07.013. Epub 2020 Jul 18. | |
| 33838303 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum and nasopharyngeal swab collected in Copan UTM media
| Poljak M, Ostrbenk Valencak A, Strumbelj E, Maver Vodicar P, Vehovar V, Resman Rus K, Korva M, Knap N, Seme K, Petrovec M, Zupan B, Demsar J, Kurdija S, Avsic Zupanc T. Seroprevalence of severe acute respiratory syndrome coronavirus 2 in Slovenia: results of two rounds of a nationwide population study on a probability-based sample, challenges and lessons learned. Clin Microbiol Infect. 2021 Jul;27(7):1039.e1-1039.e7. doi: 10.1016/j.cmi.2021.03.009. Epub 2021 Apr 7. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |