COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)
- Conditions
- Coronavirus Infectious Disease 2019 (COVID-19)
- Registration Number
- NCT04625257
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1600
- symptomatic patients getting tested for COVID-19
- mentally incompetent adults
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft
🇨ðŸ‡Liestal, Switzerland