NCT05165719

Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination

Validation of Specificity, Sensitivity, and Accuracy for an ELISpot-based In-vitro Diagnostic (IVD) Kit 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Accuracy validation of the designed and manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' for detection of SARS-CoV-2-specific T cells.

Detailed description

The investigators enrolled three independent cohorts of vaccinated (n = 69), convalescent (n = 50), and healthy but unvaccinated individuals (n = 101). Further, they estimated the T cell response to the designed peptide antigen panel, as measured by the manufactured ELISpot-based in vitro diagnostic 'Corona-T-test' to detect SARS-CoV-2-specific T cells.

Conditions

• SARS-CoV-2 Infection
• SARS-CoV-2 Vaccination

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Corona-T-test	Corona-T-test - a single-color enzymatic ELISpot kit for the detection of interferon-gamma (IFNɣ), produced by the National Research Center for Hematology aiming detection of SARS-CoV-2-specific T cells

Timeline

• Start date: 2021-07-07
• Primary completion: 2021-09-21
• Completion: 2021-11-20
• First posted: 2021-12-21
• Last updated: 2021-12-21

Locations

1 site across 1 country: Russia