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Clinical Trials/NCT04678024
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

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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