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

June 23, 2020 updated by: Szeged University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary
        • Recruiting
        • University of Szeged, Albert Szent-Györgyi Health Center
        • Contact:
          • Katalin Burián, MD
          • Phone Number: +36 62 544 000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults, Hungarian

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive group
Subjects are diagnosed with SARS-CoV2 by qPCR assay.
Diagnostic test: Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
Negative group
Subject were 2 times proved negative SARS-CoV2 by qPCR assay.
Diagnostic test: Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the method by SARS-CoV2 ELISA compared
Time Frame: 8 months
Sensitivity of the method by SARS-CoV2 ELISA compared
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detectability of the antibodies IgA type against SARS-CoV2 virus
Time Frame: 8 months
Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Collaborators

Bilogical Research Centre, Szeged

Investigators

  • Principal Investigator: Katalin Burián, MD, University of Szeged, Institute of Clinical Microbilogy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 10, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SARS-CoV-2-IIF-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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