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

NCT04625257 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2024-02-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ETH Zurich Department for Biosystems, Science and Engineering

    collaborator UNKNOWN

  • Kanton Basel- Landschaft

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-24
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625257 on ClinicalTrials.gov