COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04625257

Collaborator

ETH Zurich Department for Biosystems, Science and Engineering (Other), Kanton Basel- Landschaft (Other)

3,000

Enrollment

Location

13.2

Anticipated Duration (Months)

226.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infectious Disease 2019 (COVID-19)	Other: Saliva based assay: crude RNA extraction Other: Validation of the NGS method Other: Validation of the LAMP assays Other: Validation of the POCT Antigen and Antibody tests

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COVID-19 in Baselland: Validation of Simple and Accurate Tests for COVID-19 Detection, Monitoring and Tracing (ACCURATE-BL-COVID-19)

Actual Study Start Date :

Oct 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

symptomatic patients getting tested for COVID-19

Exclusion Criteria:

mentally incompetent adults

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft	Liestal		Switzerland	4410

Sponsors and Collaborators

University Hospital, Basel, Switzerland
ETH Zurich Department for Biosystems, Science and Engineering
Kanton Basel- Landschaft

Investigators

Principal Investigator: Miodrag Savic, Dr. med. Dr. med. dent., Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft