Evaluation and validation of a novel blood collecting system using a finger prick for SARS-CoV-2 serology.
Completed
- Conditions
- coronaCOVID-1910047438
- Registration Number
- NL-OMON51045
- Lead Sponsor
- Streeklab Haarlem
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>* The clinically functional outcome measure of the Wantai serological tests on<br /><br>capillary blood (serum collected with the Ser-Col device) will be compared with<br /><br>the outcome measures of the Wantai® tests on the venous blood sample for the<br /><br>detection of total (combined IgM and IgG) antibodies against SARS-CoV-2. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>* The difference in sensitivity and specificity for the detection of total<br /><br>SARS-CoV-2 antibodies in saliva versus venous and capillary blood.<br /><br>* Quantitative differences in measured titers of total antibodies against<br /><br>SARS-CoV-2 using the Wantai® assay between the two blood collecting systems,<br /><br>and saliva using a micro-array.</p><br>