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

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

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection; SARS-CoV-2 Vaccination
• Intervention / Treatment: Diagnostic test: Corona-T-test

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.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 125167
    • National Research Center for Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The attendees of the LTT 'DNKOM' were screened for the inclusion/exclusion criteria with a questionnaire and the above-mentioned serology tests.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccinated; 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; 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
Convalescents; PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment	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
Healthy donors; No self-reported COVID-19 infection	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Research Center for Hematology, Russia
• Collaborators: Federal Research Institute of Pediatric Hematology, Oncology and Immunology; DNKOM LLC
• Investigators: Principal Investigator: Grigory A Efimov, MD PhD, National Research Center for Hematology

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Corona-T-test

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No