NCT04678024UnknownNot Applicable
Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country410 target enrollmentStarted: November 18, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Sensitivity
Study Overview
Brief Summary
The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All patients or individuals exposed to Sars-Cov2 Infection.
Exclusion Criteria
- •There are no criteria for excluding patients or individuals, if not the refusal to participate to project
Outcomes
Primary Outcomes
Sensitivity
Time Frame: Up to 22 weeks
Sensitivity and Specificity Evaluation in Diagnostic Sierological tests
Secondary Outcomes
- Specificity(Through study completion, an average of 1 year)
Investigators
Study Sites (1)
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