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

NCT04625257 — Unknown, 1600 participants, University Hospital, Basel, Switzerland

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Registry	NCT04625257
Status	Unknown
Study type	Observational
Enrollment	1600 (Estimated)
Sponsor	University Hospital, Basel, Switzerland (Other); collaborators: ETH Zurich Department for Biosystems, Science and Engineering, Kanton Basel- Landschaft
Conditions	Coronavirus Infectious Disease 2019 (COVID-19)
Interventions	Saliva based assay: crude RNA extraction, Validation of the NGS method, Validation of the LAMP assays, Validation of the POCT Antigen and Antibody tests (Other)
Dates	start 2020-10-24, primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2020-11-12, last updated 2024-02-23
Locations	1 site in Switzerland

-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.

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+Arms and interventions

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.

+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* symptomatic patients getting tested for COVID-19

Exclusion Criteria:

* mentally incompetent adults

+Locations (1)

Facility	City	Country	Status
Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft	Liestal	Switzerland	Recruiting

+Investigators

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