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

Recruiting
Coronavirus Infectious Disease 2019 (COVID-19)

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.

Eligibility Criteria

Inclusion Criteria:

- symptomatic patients getting tested for COVID-19

Exclusion Criteria:

- mentally incompetent adults

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Switzerland
Locations

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

Investigator: Miodrag Savic, Dr. med. Dr. med. dent.
Contact: +41 79 485 31 13
miodrag.savic@usb.ch

Contacts

Miodrag Savic, Dr. med. Dr. med. dent.
+41 79 485 31 13
miodrag.savic@usb.ch

Juerg Sommer, Dr.

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

University Hospital, Basel, Switzerland
NCT Number
Keywords
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay
point of care tests (POCT)
next-generation sequencing (NGS) method
contact tracing
transmission chains
crude RNA extraction from saliva
loop mediated amplification (LAMP) assay
viral nucleic acid analysis platform
MeSH Terms
COVID-19
Coronavirus Infections
Communicable Diseases
Infections
Antibodies