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| Name | Class |
|---|---|
| ETH Zurich Department for Biosystems, Science and Engineering | UNKNOWN |
| Kanton Basel- Landschaft | UNKNOWN |
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This study is to establish an accurate, robust and easily scalable COVID-19 viral nucleic acid analysis platform from, but not limited to, saliva to help enable and support contact tracing in the canton of Baselland/ Switzerland. To achieve this, crude ribonucleotide acid (RNA) extraction from saliva is validated in combination with next-generation sequencing (NGS) diagnostics and loop mediated amplification (LAMP) assays as well as point of care test (POCT) for rapid detection of viral antigens on patients' samples.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saliva based assay: crude RNA extraction | Other | Crude RNA extraction to inactivate the virus and stabilize the RNA for transport at room temperature. Validation of the crude RNA extraction from saliva in combination with NGS diagnostics and LAMP assays and point of care test (POCT) for rapid detection of viral antigens on patients' samples. | ||
| Validation of the NGS method | Other | Compare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab. | ||
| Validation of the LAMP assays | Other | The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay. | ||
| Validation of the POCT Antigen and Antibody tests | Other | Rapid point of care tests (POCT) detecting viral protein antigens (Ag) and antibodies (Ab) on patients' samples. POCT are often employed in low income countries, but for COVID-19 they are not yet characterized. Their performance is to be characterized that they can be used as a safe guard if the lab diagnostics fail. |
| Measure | Description | Time Frame |
|---|---|---|
| qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection) | For all qualitative method validation, the qualitative and quantitative result of the Foederatio Analyticorum Medicinalium Helveticorum (FAMH) performed RT-PCR (patient does / does not have SARS-Cov-2 and if yes, how many "ct" values for detection) is considered as the gold standard against which the crude extraction in combination with the LAMP or the NGS method using univariate measures is compared. | single point assessment at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Symptomatic patients arriving at the COVID-19 test center Feldreben in Muttenz, Basel Land and at Swiss TPH in Basel, Basel Stadt to get tested for COVID-19.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miodrag Savic, Dr. med. Dr. med. dent. | Contact | +41 79 485 31 13 | miodrag.savic@usb.ch | |
| Juerg Sommer, Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Miodrag Savic, Dr. med. Dr. med. dent. | Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft | Recruiting | Liestal | 4410 | Switzerland |
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Biological material is appropriately stored in a restricted area only accessible to authorized personnel. Until completion of the study, the material will be stored in the biobank "SERO-BL-COVID-19".
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000917 | Antibody Formation |
| ID | Term |
|---|---|
| D007110 | Immunity, Active |
| D056704 | Adaptive Immunity |
| D007109 | Immunity |
| D055633 | Immune System Phenomena |
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