1. The primary objective is to evaluate whether Ser-Col for SARS-CoV-2 antibody detection is an acceptable alternative for standard venous blood collection. 2. The secondary objective is to compare SARS-CoV-2 antibody detection in (venous and…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In this study, we want to evaluate and validate the novel blood collecting
system Ser-Col, developed for the self-collection of capillary blood by
participants with a finger prick, in comparison to venous blood collection for
the detection of antibodies against severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2). Moreover, we want to compare SARS-CoV-2 antibody
response in saliva versus blood.
Study objective
1. The primary objective is to evaluate whether Ser-Col for SARS-CoV-2 antibody
detection is an acceptable alternative for standard venous blood collection.
2. The secondary objective is to compare SARS-CoV-2 antibody detection in
(venous and capillary) blood with detection of antibodies in saliva.
Study design
Single center comparative study in the Spaarne Gasthuis, the Netherlands, in
which detection of total SARS-CoV-2 antibody levels in both blood collection
systems and saliva will be compared. The samples will be collected 6 weeks
after the first day of symptom onset to obtain an acceptable antibody yield.
Study burden and risks
The burden of participating in this study is minimal. Blood collection will
take place only once and will be performed with a finger prick and
venipuncture, which may cause transient mild discomfort and only rarely
infection or bleeding. In addition, saliva will be collected. The potential
benefits of the finger prick over the venipuncture are the less invasive nature
and the fact that people can perform the blood collection themselves at home.
Saliva collection is an easy and non-invasive method and will represent no
burden. This will make it possible to quickly determine the seroprevalence or
SARS-CoV-2 vaccination response in large populations without laborous and
invasive methods. Participants will acquire their test results through mail
after the study has finished and the results have been analyzed.
Boerhaavelaan 26
Haarlem 2035 RC
NL
Boerhaavelaan 26
Haarlem 2035 RC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76448.029.21 |