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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429620
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Bilogical Research Centre, Szeged
Information provided by (Responsible Party):
Szeged University

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

Condition or disease Intervention/treatment
Sars-CoV2 Diagnostic Test: Immunfluorescence

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
Actual Study Start Date : May 30, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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.




Primary Outcome Measures :
  1. Sensitivity of the method by SARS-CoV2 ELISA compared [ Time Frame: 8 months ]
    Sensitivity of the method by SARS-CoV2 ELISA compared


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults, Hungarian
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429620


Contacts
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Contact: Katalin Burián, MD +36 62 544 000 burian.katalin@med.u-szeged.hu
Contact: Dávid Pintér, Pharm. D.

Locations
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Hungary
University of Szeged, Albert Szent-Györgyi Health Center Recruiting
Szeged, Hungary
Contact: Katalin Burián, MD    +36 62 544 000      
Sponsors and Collaborators
Szeged University
Bilogical Research Centre, Szeged
Investigators
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Principal Investigator: Katalin Burián, MD University of Szeged, Institute of Clinical Microbilogy
Additional Information:
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Responsible Party: Szeged University
ClinicalTrials.gov Identifier: NCT04429620    
Other Study ID Numbers: SARS-CoV-2-IIF-002
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No