Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
- Conditions
- Sars-CoV2
- Interventions
- Diagnostic Test: Immunfluorescence
- 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
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
- Arm && Interventions
Group Intervention Description Negative group Immunfluorescence Subject were 2 times proved negative SARS-CoV2 by qPCR assay. Positive group Immunfluorescence Subjects are diagnosed with SARS-CoV2 by qPCR assay.
- 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