Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method

• Conditions: Sars-CoV2

• Registration Number: NCT04429620
• Lead Sponsor: Szeged University

Brief Summary

Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Detailed Description

Sample preparation, serum separation by centrifugation

* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.

* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope

Study Timeline

• Study Start: 2020-05-30
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Person over 18 years of age
• Signing a package leaflet and a informal consent
• In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
• In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual

Exclusion Criteria

• Refuses to sign the consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the method by SARS-CoV2 ELISA compared	8 months	Sensitivity of the method by SARS-CoV2 ELISA compared

Secondary Outcome Measures

Name	Time	Method
Detectability of the antibodies IgA type against SARS-CoV2 virus	8 months	Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.

Trial Locations

Locations (1)

University of Szeged, Albert Szent-Györgyi Health Center; 🇭🇺 Szeged, Hungary