Immunological memory responses of patients infected with COVID-19. [COVID-19]
Research type
Research Study
Full title
Evaluation of serological assays to determine immunological memory responses of COVID-19 patients.
IRAS ID
284654
Contact name
Nuthar Jassam
Contact email
Sponsor organisation
Harrogate and District NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, days
Research summary
Serological testing is vital for understanding the scale of the pandemic, future vaccine utility, in the monitoring of patient on convalescent treatment and for the assessment of the immune response to COVID-19.\n\nThe main research question concerning serology testing would be how long is immunity to COVID-19 likely to last? The answer to this question comes from analysing sera from SARS-CoV-2 PCR positive patients on a regular basis using serology tests. However, the current serology tests have not been independently verified clinically or biochemically. The evaluation of serology test is prerequisite to answering the research question concerning the length of COVID-19 immunity.\n\nIn response to the release of serological testing for COVID-19, we propose to evaluate newly released assays for antibody measurements. Unlike PCR tests for COVID-19, serology testing is not a diagnostic test. The serology test supports the detection of antibodies against SARS-COV-2 in patients who have been exposed to the virus that causes COVID-19. The detection of these antibodies could help indicate if a person has gained immunity against the virus and supports informed treatment/vaccine decisions.\n \n\nThe antibody response in COVID-19 infected patients remains unknown and there are multiple requirements that need to be addressed before trusting serological testing for SARS-CoV-2. To minimize the number of false positive results, serological tests must be well-designed to specifically identify antibodies against SARS-CoV-2 and must not “cross-react” or provide positive results when encountering antibodies against other respiratory viruses, such as seasonal Coronavirus. To identify the true negativity of this assay, we aim to study healthy volunteer samples collected before the COVID - 19 outbreaks. Sensitivity will be assessed using redundant samples from PCR positive COVID-19 patients. \n\nMost evaluation efforts for serology assays included people who have been hospitalised with severe infection . In this group, around 90% develop IgG antibodies within the first 2 weeks of symptomatic infection . However, whether the same immune response occurs in community patients who either have milder disease or no symptoms is unknown. Therefore similar data are urgently needed for individuals with SARS-CoV-2 infection who have not been hospitalised. Samples will be collected over a period of 12 months to test the immunity to COVID-19 in patients with mild disease presentation. \n
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0190
Date of REC Opinion
29 Jul 2020
REC opinion
Further Information Favourable Opinion