Abstract
Background Rapidly undertaken age-stratified serology studies can produce valuable data about a new emerging infection including background population immunity and seroincidence during an influenza pandemic. Traditionally seroepidemiology studies have used surplus laboratory sera with little or no clinical information or have been expensive detailed population based studies. We propose collecting population based sera from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), a sentinel network with extensive clinical data. Aim To pilot a mechanism to undertake population based surveys that collect serological specimens and associated patient data to measure seropositivity and seroincidence due to seasonal influenza, and create a population based serology bank. Methods and analysis Setting and Participants: We will recruit 6 RCGP RSC practices already taking nasopharyngeal virology swabs. Patients who attend a scheduled blood test will be consented to donate additional blood samples. Approximately 100-150 blood samples will be collected from each of the following age bands-18-29, 30-39, 40-49, 50-59, 60-69 and 70+ years. Methods We will send the samples to the Public Health England (PHE) Seroepidemiology Unit for processing and storage. These samples will be tested for influenza antibodies, using haemagglutination inhibition assays. Serology results will be pseudonymised, sent to the RCGP RSC and combined using existing processes at the RCGP RSC secure hub. The influenza seroprevalence results from the RCGP cohort will be compared against those from the annual PHE influenza residual serosurvey. Ethics and dissemination Ethical approval was granted by the Proportionate Review Sub-Committee of the London-Camden & Kings Cross on 6 February 2018. This study received approval from Health Research Authority on 7 February 2018. On completion the results will be made available via peer-reviewed journals.
| Original language | English |
|---|---|
| Article number | e024285 |
| Journal | BMJ Open |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 1 Mar 2019 |
Bibliographical note
Funding Information:This research and information governance framework for RCGP RSC sits within the University of Surrey’s formal frameworks for information and research governance. In addition, all externally funded projects and collaborative projects with external partners are supported and guided by the University’s Research and Enterprise Support (RES) service. RES ensures that university-supported projects are financially viable, and that legal issues of knowledge transfer and intellectual properties are addressed. The project team is supported by IT services dedicated to the Faculty and to the Department of Clinical and Experimental Medicine. Our secure analysis servers are optimised for routine healthcare data processing, to provide faster deliveries for our projects.
Funding Information:
This work was supported by the University of Surrey. The funding was obtained as part of the Higher Education Funding Council for England’s (HEFCE) Industrial Strategy funding allocated to the University.
Funding Information:
Simon de Lusignan has received grant funding through University of Surrey from GSK to report vaccine adverse events and attended advisory boards for Sanofi and Seqirus.
Publisher Copyright:
© © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Keywords
- computerized
- data collection
- influenza, human
- medical records systems
- pandemics
- population surveillance
- primary health care
- records as topic
- seroepidemiologic studies
- serology
