Sensitivity Evaluation of Serological Tests for Covid-19

Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04678024

Acronym

COVIDIAGNOSTIX

Enrollment

410

Registered

2020-12-21

Start date

2020-11-18

Completion date

2021-11-30

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

test sierologici

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	Up to 22 weeks	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Secondary

Measure	Time frame	Description
Specificity	Through study completion, an average of 1 year	Sensitivity and Specificity Evaluation in Diagnostic Sierological tests

Other

Measure	Time frame
HTA	Up to 20 weeks

Countries

Italy

Outcome results