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

University of Szeged (SZTE)

Status: Unknown

Conditions: Sars-CoV2

Treatments: Diagnostic Test: Immunfluorescence

Study type: Observational

Funder types: Other

Identifiers

NCT04429620

SARS-CoV-2-IIF-002

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Positive group

Description:

Subjects are diagnosed with SARS-CoV2 by qPCR assay.

Treatment:

Diagnostic Test: Immunfluorescence

Negative group

Description:

Subject were 2 times proved negative SARS-CoV2 by qPCR assay.

Treatment:

Diagnostic Test: Immunfluorescence