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Evaluation and validation of a novel blood collecting system using a finger prick for SARS-CoV-2 serology.

Evaluation and validation of a novel blood collecting system using a finger prick for SARS-CoV-2 serology. - Ser-CoV

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51045
Enrollment
100
Registered
2021-03-25
Start date
2021-04-27
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona COVID-19

Interventions

None listed

Sponsors

Streeklab Haarlem
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Voluntary participants with an age of 18 years or older. He or she must be able to read and understand the informed consent form and to independently perform a capillary blood collection. - At least 1 PCR confirmed SARS-CoV-2 infection OR a positive result in serology through venous blood collection

Exclusion criteria

Exclusion criteria: - Voluntary participants under 18 years old. - Absence of PCR confirmed SARS-CoV-2 infection OR patients with a confirmed respiratory infection with a pathogen other than SARS-CoV-2 OR patients with negative test result for SARS-CoV-2 serology in venous blood collection.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: * The clinically functional outcome measure of the Wantai serological tests on capillary blood (serum collected with the Ser-Col device) will be compared with the outcome measures of the Wantai® tests on the venous blood sample for the detection of total (combined IgM and IgG) antibodies against SARS-CoV-2.

Secondary

MeasureTime frame
Secondary endpoints: * The difference in sensitivity and specificity for the detection of total SARS-CoV-2 antibodies in saliva versus venous and capillary blood. * Quantitative differences in measured titers of total antibodies against SARS-CoV-2 using the Wantai® assay between the two blood collecting systems, and saliva using a micro-array.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)