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UK's CONDOR Platform to Assess New SARS-CoV-2 Tests in Different Clinical Settings

NEW YORK ─ There is a steady pipeline of new tests for SARS-CoV-2 coming onto the market, but clinicians might be at a loss to determine not only their efficacy but their optimal use cases. To answer these questions the UK National Institute for Health Research will bankroll a new multicenter project across the country to assess how tests perform in hospitals, general practitioners' officers, and in care homes. 

The effort, called the COVID-19 National Diagnostic Research and Evaluation Platform (CONDOR), commenced last month with a budget of £1.3 million ($1.6 million) for the first year. Data generated via the platform will be used to inform UK National Health Service policy.

"CONDOR will share the results of evaluations with the Department of Health and Social Care, so that this information is available to decision makers," noted Philip Turner, a senior researcher at the NIHR's Community Healthcare MedTech and In Vitro Diagnostic Cooperative (MIC) at the University of Oxford, and a co-lead for the new platform.

According to Turner, CONDOR is working within the NHS to carry out evaluations. He said a "large proportion of the CONDOR team" are actually clinicians and clinical scientists who work in frontline clinical roles. "Fundamentally, the NIHR is the research arm of our NHS," he said.

In addition to the Oxford NIHR MIC, the CONDOR platform will include similar MICs in Leeds, London, and Newcastle. The Manchester University NHS Foundation Trust Diagnostics and Technology Accelerator (DiTA) is also involved in CONDOR, as are partners at the University of Nottingham, the UK National Measurement Laboratory, and the Yorkshire and Humber Academic Health Science Network.

In addition to NIHR, Asthma UK and the British Lung Foundation have also backed CONDOR. Yet Turner said much of the platform's core competencies in evaluating diagnostics already exist, and the platform will not immediately require additional funding.

"The funding is building largely on existing NIHR infrastructure, so the starting baseline is quite high, as we are a collection of groups that have specialized in the evaluation of diagnostic tests for many years," noted Turner.

Gail Hayward, deputy director of the NIHR's Community Healthcare MIC at Oxford, said those involved decided to launch the platform to overcome challenges in testing for SARS-CoV-2, the virus that causes COVID-19.

"Current real-time PCR tests for coronavirus are slow – it can take up to three days to receive results," noted Hayward, who is also co-lead on the platform. "As a GP, I know it would be really useful to have a simple bedside test which can give us rapid results to tell us if someone has coronavirus or not," she said.

Noting that many companies in the UK and internationally have been developing rapid tests that rely on a variety of sample inputs, Hayward said it was imperative that the UK have a route for assessing such assays before implementing them in different clinical settings.

"Before we start to use these tests, we need to know how good they are at detecting those people who have, and don't have, coronavirus," said Hayward. "Our study will see how these tests perform, where they will actually be used by doctors and nurses in hospitals, care homes, and GP surgeries."

The CONDOR platform has provided information for manufacturers on how to submit tests for evaluation. Turner said CONDOR would primarily be interested in evaluating tests for active SARS-CoV-2 infection, such as molecular-based assays for the detection of viral RNA and viral antigen-based tests, although it will "be responsive to the needs of the system as the science develops."

According to its website, CONDOR has multiple clinical evaluation studies planned, each focused on a different setting. The Falcon-C19 study will cover hospital emergency departments, inpatient areas, acute medical units and critical care, and hospital-at-home services. The CONDOR-CH study will work with the care home sector to understand how staff and residents respond to and manage new technologies. And Raptor-C19 is a research study to assess the accuracy of different rapid tests for COVID-19 for patients in the community as administered via GP offices.

There are also three cross-cutting studies planned as part of CONDOR. A care pathway mapping study will identify where new technologies could have the most impact on patient health during the different phases of the pandemic. There is also a human factors evaluation study planned to evaluate how people interact with new technologies in a real-world healthcare setting. An analytical performance study will help investigators decide on which tests to try out in different clinical settings.

Less than a month in, Turner said that laboratory evaluations are already taking place within the analytical performance workstream, and the first tests have been introduced into Falcon-C19 in Manchester, where investigators have been recruiting patients for weeks. CONDOR-CH and Raptor-C19 are also about to commence, but researchers are still settling on candidate tests.

The ultimate aim of these studies will be to provide analytical performance evidence for new tests, as well as in-context clinical performance evidence for new diagnostics. "By in context, we mean that the diagnostic will be used in real clinical settings, in an observational manner, with real patients suspected of infection with SARS-CoV-2, as this will provide evidence of how reliable these tests are likely to be if they are deployed in clinical settings for clinical decision making," noted Turner. "Comparisons will be made against established reference standard, standard-of-care, diagnostic tests."

Methods of evaluation will differ depending on the particular test. If candidate diagnostics already have sufficient evidence in terms of analytical performance and safety, CONDOR's investigators might decide to deploy them quickly to clinical settings for in-field testing. For field testing, sample sizes will be calculated based on the estimated prevalence of infection in the target patient group, as well as the estimated diagnostic performance of the tests, Turner said.

He noted that the protocol for the Falcon-C19 study has already been made available, and that the protocol for Raptor-C19 should follow shortly.

In terms of test selection, Hayward said that CONDOR will prioritize tests that the Department of Health and Social Care believes have the "potential to enhance patient care and build testing resilience in the NHS." She noted that the platform aims to inform procurement decisions by providing "good quality evidence for how well these tests perform in a variety of settings."

It's unclear if any other countries in Europe have established similar platforms for evaluating new tests. In February, the Foundation for Innovative New Diagnostics issued an expression of interest to developers of tests for SARS-CoV-2 to have their assays evaluated using a standardized, independent protocol. Study results would be shared with the global health community to inform diagnostic testing approaches, the Geneva, Switzerland-based nonprofit said at the time.

"FIND is focusing mainly on assessing the analytical accuracy of new COVID-19 diagnostics, and we hope in due course to take forward some of the tests that they have found to perform well into evaluation in clinical settings," said Hayward when asked about any overlap between the two programs. She said she was not aware of any other similar programs in Europe at this time.