Sensitivity Evaluation of Serological Tests for Covid-19

NCT ID: NCT04678024

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Keywords

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test sierologici

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Banfi

Role: PRINCIPAL_INVESTIGATOR

IRCCS Orthopedic Institute Galeazzi

Locations

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Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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COVIDIAGNOSTIX

Identifier Type: -

Identifier Source: org_study_id