An observational study in SARS-CoV-2 Infection and SARS-CoV-2 Vaccination, sponsored by National Research Center for Hematology, Russia. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by National Research Center for Hematology, Russia · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 220 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →National Research Center for Hematology, Russia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The attendees of the LTT 'DNKOM' were screened for the inclusion/exclusion criteria with a questionnaire and the above-mentioned serology tests.
Non-specific inclusion criteria
Healthy donors inclusion criteria
Convalescents inclusion criteria
Vaccinated inclusion criteria
Exclusion criteria
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
PCR (polymerase chain reaction) confirmed COVID-19 in a period 14-45 days before recruitment
Diagnostic Test: Corona-T-test
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
The result of Corona-T-test
positive, negative, or inconclusive (gray-zone)
Time frame: 1 week
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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National Research Center for Hematology, Russia