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Using medical-detection dogs to identify people with SARS-CoV-2. Phase I-III studies. Application for participant results details.

Safe People

Organisation name

London School of Hygiene and Tropical Medicine

Organisation sector

Academic Institute

Sub-licence arrangements (if any)?

No

Safe Projects

Project ID

DARS-NIC-426830-M1C1K-v0.2

Lay summary

ARCTEC, the commercial arm of The London School of Hygiene and Tropical Medicine (LSHTM) is requesting details of study participants’ COVID test results obtained at Pillar 2 sites and NHS hospitals. The data request is being made to support an HRA-approved study “Using Medical Detection Dogs to identify people with SARS-CoV-2. Phase 1, Proof-of-concept studies”. This study, initiated in 2020, will assess the sensitivity and specificity of medical detection dogs in identifying SARS-CoV-2 infection. The success of this study would aid in preventing future outbreaks of the virus, as the medical detection dogs could provide a high-throughput screening tool in key public risk areas such as airports. ARCTEC is a wholly owned subsidiary of the LSHTM, all staff are employed on LSHTM contracts, housed in LSHTM building and supported by the same infrastructure [IT and Data Protection Office]). ARCTEC staff have acted as the Trial Coordinating Centre for this study, leading study activities, and recruiting all volunteers for the current data application. Following the changing path of the epidemic in the UK, the Department of Health and Social Care (DHSC) has made a request for evidence that: ~ The medical detection dogs can detect COVID-19 in people with new viral strains. ~ The dogs can detect COVID-19 in people with low viral loads, and asymptomatic individuals. The aim of this data request is to identify key subsets within the existing samples (people with variant of concern, low viral load), and test these samples to assess whether dogs’ screening accuracy remains consistent under these variations. The SARS-CoV-2 ‘Kent’ viral strain (SARS-CoV-2, variant of concern 202012/01) shows S-gene target failure in commonly used Polymerase Chain Reaction (PCR) assays (a method of amplifying tiny amounts of genetic material e.g. DNA, from a sample so it can be detected more easily. It runs in cycles with a higher amount of genetic material present after each cycle is complete). The data requests will give details of assay outcomes, which can be used to infer which participants may have been infected with the ‘Kent’ strain. Recruitment to the study was conducted between August 2020 and January 2021. As the ‘Kent’ strain became common in the UK in December 2020, it is highly likely that the study contains a mix of samples representing different viral strains. London School of Hygiene and Tropical Medicine requires further data from the COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2) Dataset to understand which strain of SARS-CoV-2 participants were infected with when the individual tested positive and the onset of symptoms for approximately 900 study participants. Test outcomes, symptom start dates and PCR cycle thresholds (Ct thresholds) will be used to assess claims around screening success in people with no symptoms/ low viral load. Release of data will be needed for modelling studies assessing the detection dogs’ utility in different screening scenarios (low/ high infection prevalence, and at ports of entry with novel viral strains present). Release of data will impact the study team’s ability to obtain funding for phase 2. The scope of this data request is to provide data useful to the current study phase (phase 1, proof of principle), next phase (phase 2, in-person training with healthy volunteers) and input into the accessory modelling study. The LSHTM is the sole Data Controller and Processor. Medical Detection Dogs (MDD), University of Durham and DHSC will not process the NHS Digital pseudonymised data. They will however be given access to sections of aggregated data (in line with the HES analysis guide) in order to assess and report on study outcomes (chiefly the dogs’ sensitivity and specificity in screening key subset groups). The aggregated data provided to MDD will contain group information (viral load, strain type), sent via encrypted file transfer. The Trial Steering Committee have an advisory role, they do not have any control over how NHS Digital data is used or access to these data (except in the form of aggregated (with small numbers suppressed) trial results produced for or presented at these meetings). They provide advice, guidance, and support to the trial. The Trial Steering Committee meet virtually, and are chaired by an LSHTM staff member. The research is funded by the Department of Health and Social Care (DHSC). DHSC does not have access to data, except for aggregated reports (with small numbers suppressed) on study outcomes, which do not contain identifiable information. The data is being processed under the following legal basis: GDPR 6 (1) (e): Public Task; The study is performing research on a disease of high public health importance, and the data request is required to as part reporting requirements put in place by government stakeholders and GDPR 9(2)(j): Public health research; This research is on a screening tool for COVID-19, a disease of public health importance. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). There will be no requirement nor attempt to re-identify individuals from the data. The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement.

Public benefit statement

The expected benefits of the study are the testing and validation of a medical detection dogs as a screening tool for identification of COVID-19. If found to be an accurate screening tool, medical detection dogs could be deployed at key ports of entry, and high risk public gatherings to quickly and accurately identify people with COVID-19. Preliminary results from phase I of the study have been promising in indicating that the Medical Detection Dogs are able to detect samples from positive participants. Medical Detection Dogs are able to screen up to 250 individuals per hour, and are suitable tools for a number of settings, including but not limited to border points, public events, and screening of groups for whom nasal swabs are unfeasible or distressing. The application of dogs could provide a key tool in preventing further outbreaks of the SARS-CoV-2. If dogs are established as screening tools in such locations, this could have a noticeable impact on future considerations to alleviate lockdown measures. The data from NHS Digital will be crucial ensuring that the dogs are trained not just to detect the virus, but also picking up variation in virus strain, viral loads, and asymptomatic infected individuals. The knowledge of these details in individuals can enable targeted strategies for treating them and preventing spread.

Latest approval date

23/03/2021

Safe Data

Dataset(s) name
Data sensitivity level

Personally Identifiable

Legal basis for provision of data under Article 6

Health and Social Care Act 2012 – s261(2)(c)

National data opt-out applied?

Consent (Reasonable Expectation)

Request frequency

One-Off

Safe Setting

Access type

TRE