Coronavirus Infectious Disease 2019 (COVID-19)
Conditions
Keywords
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay, point of care tests (POCT), next-generation sequencing (NGS) method, contact tracing, transmission chains, crude RNA extraction from saliva, loop mediated amplification (LAMP) assay, viral nucleic acid analysis platform
Brief summary
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.
Interventions
OTHERSaliva based assay: crude RNA extraction
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.
OTHERValidation of the NGS method
Compare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab.
OTHERValidation of the LAMP assays
The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.
OTHERValidation of the POCT Antigen and Antibody tests
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.
Sponsors
ETH Zurich Department for Biosystems, Science and Engineering
Kanton Basel- Landschaft
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* symptomatic patients getting tested for COVID-19
Exclusion criteria
* mentally incompetent adults
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection) | single point assessment at baseline | 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. |
Countries
Switzerland
Contacts
Primary ContactMiodrag Savic, Dr. med. Dr. med. dent.
Backup ContactJuerg Sommer, Dr.
Outcome results
None listed