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

National Research Center for Hematology, Russia220 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

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

Interventions

Corona-T-testDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Non-specific inclusion criteria * Participants aged 18 and above * Participants agreeing to follow the study procedures * Participants able to understand the purpose, nature, and methodology of the study * Participants having signed the informed consent Healthy donors inclusion criteria * No self-reported COVID-19 infection * No vaccination against COVID-19 * No immunoglobulin (Ig) IgM or IgG antibodies against SARS-CoV-2 by three tests (IgM to SARS-CoV-2 detection: "SARS-CoV-2-IgМ-ELISA-BEST", Ref #D-5502, IgG to SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-quantity-ELISA-BEST", "Vector-Best", Ref #D-5505), IgG to SARS-CoV-2 N protein detection: "SARS-CoV-2 IgG Reagent Kit", ARCHITECT, Abbott Laboratories, EU) Convalescents inclusion criteria * Self-reported COVID-19 infection * PCR confirmed COVID-19 in a period 14-45 days before recruitment * Detectable IgG antibodies against SARS-CoV-2 (IgG to RBD domain of SARS-CoV-2 S protein detection: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G) Vaccinated inclusion criteria * SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment * Detectable IgG antibodies against SARS-CoV-2 (IgG to receptor-binding domain (RBD) domain of SARS-CoV-2 S protein: "SARS-CoV-2-IgG-ELISA", "National Medical Research Center for Hematology", Moscow, Russia. Ref #K153G) Exclusion criteria \- Age under 18 y.o.

Locations (1)

National Research Center for Hematology

Moscow, Russia

Outcomes

Primary Outcomes

The result of Corona-T-test

positive, negative, or inconclusive (gray-zone)

Time frame: 1 week

Data from ClinicalTrials.gov

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