Longitudinal monitoring of SARS-CoV-2 antibodies in Covid-19 patients
Research type
Research Study
Full title
Longitudinal monitoring of SARS-CoV-2 antibodies in patients diagnosed with Covid-19.
IRAS ID
290673
Contact name
Claire Richardson
Contact email
Sponsor organisation
NHS Lanarkshire
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Currently there is little information concerning the longevity of the antibody response to Severe Acute Respiratory System Coronavirus 2 (SARS-CoV- 2), however it is known that antibodies to other human coronaviruses wane over time. Obtaining longitudinal antibody data stratified by age groups, sex and disease severity is required as a matter of urgency. Data on the accuracy of antibody tests beyond 35 days is also lacking and urgently needed.
This study aims to directly address these issues by monitoring SARS-CoV-2 antibodies in patients previously diagnosed with Covid-19 to determine if levels change over time and to correlate these findings with clinical information. Results will also be compared with other commercially available SARS-Cov-2 antibody assays in an attempt to assess accuracy.
SARS-CoV-2 antibody levels will be measured over a period of approximately one year however this may be extended if outcomes remain unclear. Testing will be performed in the Biochemistry Department of University Hospital Wishaw on surplus serum from patients who have tested positive for Covid-19 by the reverse transcriptase-polymerase chain reaction (RT-PCR) method. Samples will be identified by a weekly interrogation of the Labs Information Management System (LIMS). This search will identify all serum samples taken from previously positive Covid-19 patients in primary care locations in the preceding week. All samples with sufficient volume will be analysed for antibodies by the Roche Anti-SARS-Cov-2 assay prior to disposal.
Antibody status will be correlated with time since positive PCR test, age, sex and clinical information (e.g. severity of symptoms, hospital admission, treatment etc...). In those individuals who produce an antibody response, levels will be monitored over time to determine if they increase, decrease or remain stable. Attempts will also be made to categorise any individuals who do not mount an antibody response.
REC name
Wales REC 7
REC reference
20/WA/0352
Date of REC Opinion
16 Dec 2020
REC opinion
Favourable Opinion