Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- The positivity (Yes/No) of the serological test.
Study Overview
Brief Summary
Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Seropositive caregivers screened for anti-SARS CoV2 antibodies during their consultation at the occupational medicine of HCL.
- •Age: ≥ 18 years old
- •Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
- •Persons affiliated to a social security scheme or beneficiary of such a scheme.
Exclusion Criteria
- •Pregnant or lactating woman
Arms & Interventions
Serological tests will be applied on patients blood sampling
Serological tests will be applied on patients blood sampling
Intervention: Serological tests will be applied on patients blood sampling (Diagnostic Test)
Outcomes
Primary Outcomes
The positivity (Yes/No) of the serological test.
Time Frame: Day 42
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 0
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 3
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 7
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 14
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 21
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 28
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
The positivity (Yes/No) of the serological test.
Time Frame: Day 35
The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR
Secondary Outcomes
No secondary outcomes reported