Sensitivity Evaluation of Serological Tests for Covid-19

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio410 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

410

Conditions

Covid19

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Galeazzi

Milan, Italy

Outcomes

Primary Outcomes

Sensitivity

Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Time frame: Up to 22 weeks

Secondary Outcomes

Specificity

Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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