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

University Hospital, Basel, Switzerland1,600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,600

Conditions

Coronavirus Infectious Disease 2019 (COVID-19)

Interventions

Saliva based assay: crude RNA extractionOTHER

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.

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 assaysOTHER

The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.

Validation of the POCT Antigen and Antibody testsOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * symptomatic patients getting tested for COVID-19 Exclusion Criteria: * mentally incompetent adults

Locations (1)

Cantonal Office of Public Health, Economics and Health Directorate, Canton Basel-Landschaft

Liestal, Switzerland

RECRUITING

Outcomes

Primary Outcomes

qualitative method validation of the crude extraction in combination with the LAMP or the NGS (count values for detection)

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.

Time frame: single point assessment at baseline

Central Contacts

Miodrag Savic, Dr. med. Dr. med. dent.

CONTACT

+41 79 485 31 13 miodrag.savic@usb.ch

Juerg Sommer, Dr.

CONTACT

Data from ClinicalTrials.gov

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