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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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SARS-CoV-2 Infection, SARS-CoV-2 Vaccination

Intervention / Treatment
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* Diagnostic Test: Corona-T-test


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccinated<br>SARS-CoV-2 vaccination with 'Sputnik V' (Gam-COVID-Vac) in a period 7-14 days after the second vaccination before recruitment | Diagnostic Test: Corona-T-test<br>* 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<br>|
| Convalescents<br>PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment | Diagnostic Test: Corona-T-test<br>* 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<br>|
| Healthy donors<br>No self-reported COVID-19 infection | Diagnostic Test: Corona-T-test<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The result of Corona-T-test | positive, negative, or inconclusive (gray-zone) | 1 week |