NCT04625257

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,600 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Infectious Disease 2019 (COVID-19)

Interventions

Type	Name	Description
OTHER	Saliva 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.
OTHER	Validation 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.
OTHER	Validation of the LAMP assays	The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.
OTHER	Validation 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.

Timeline

• Start date: 2020-10-24
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-11-12
• Last updated: 2024-02-23

Locations

1 site across 1 country: Switzerland