Trials / Unknown
UnknownNCT04678024
Sensitivity Evaluation of Serological Tests for Covid-19
Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 410 (estimated)
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2021-08-01
- Completion
- 2021-11-01
- First posted
- 2020-12-21
- Last updated
- 2020-12-24
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04678024. Inclusion in this directory is not an endorsement.