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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05165719

Enrollment

220

Registered

2021-12-21

Start date

2021-07-07

Completion date

2021-11-20

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DIAGNOSTIC_TESTCorona-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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026