Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER

N/AActive Not RecruitingNCT04341142

Hospices Civils de Lyon550 enrolled

Overview

Covid-SER is a prospective multi-center study for the evaluation of diagnostic performance of available serological tests

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

550

Conditions

CoV2 Positive Caregivers

Interventions

Serological tests will be applied on patients blood samplingDIAGNOSTIC_TEST

Application of tests on patients' serum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Lyon Sud,Sainte Eugénie bat 4M,5, Chemin du Grand Revoyet

Pierre-Bénite, France

Outcomes

Primary Outcomes

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 0

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 3

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 7

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 14

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 21

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 28

The positivity (Yes/No) of the serological test.

The sensitivity and specificity of serological tests (positive or negative) compared to molecular detection of the virus by PCR

Time frame: Day 35

Data from ClinicalTrials.gov

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NCT04341142 - Assessment of Serological Techniques for Screening Patients Regarding COVID-19-COVID-SER | Crick | Crick