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Tests developed by Diagnostics for the Real World (DRW), which enable clinicians to rapidly detect and differentiate between coronavirus SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus, have achieved UK technical validation.

DRW’s focus is on the accurate and rapid testing of patient samples at, or near, the point of care, avoiding the unreliability of previous simple point-of-care technologies, and the prohibitive costs and logistical difficulties of central laboratory testing.

The two new combined tests deliver highly accurate point-of-care detection for multiplex respiratory virus tests – SARS-CoV-2/FluA/FluB and SARS-CoV-2/RSV. The outcome is a vital tool for NHS care teams which boosts infection control in hospitals, optimises patient management and speeds up access to urgent care services, including emergency surgery.

The CE-marked multiplex tests are conducted on DRW’s SAMBA II platform, a fully-automated ‘sample in, result out’ diagnostic machine currently deployed in more than 100 UK hospital sites as one of the NHS’s primary point-of-care, non-lab-based Covid-19 testing solutions.

The robust, simple-to-use SAMBA II system – which can be operated with minimal training – offers a complete end-to-end process, delivering fast results and reducing the typical 24-48 hour wait from centralised laboratory tests. The SAMBA II system delivers a true point-of-care system, from sample extraction, through to isothermal nucleic acid amplification, patented lateral flow detection and automated interpretation of results.

Dr Ravi Gupta, professor of clinical microbiology at the Cambridge Institute for Therapeutic Immunology and Infectious Disease, led the initial validation of the SAMBA II SARS-CoV-2 rapid point-of-care test at Addenbrooke’s Hospital in 2020, demonstrating that the SAMBA system delivers highly accurate results 10 times faster than other diagnostic tools.

Commenting on the launch, Dr Gupta said: “With Covid remaining an ongoing challenge, prompt differential diagnosis of respiratory viruses continues to be extremely important for effectively managing patient care pathways and workflows in hospitals – from reducing the requirement for Covid ‘holding areas’ on admission and enabling faster triage, to freeing up much-needed beds on wards and allowing safe discharge to out-of-hospital settings, including to care homes.

“DRW’s new multiplex tests will be welcomed by clinicians as a key tool to help speed up access to urgent care, crucially emergency surgery and transplantation, where delays and co-infections can have very significant adverse impacts.”

The SAMBA II multiplex respiratory virus tests are nucleic acid-based amplification tests designed to accurately detect the presence of four key respiratory viruses from nose and throat swab samples run on the SAMBA II system. The tests involve combinations of SARS-CoV-2/FluA/FluB and SARS-CoV-2/RSV and have been approved by the Technical Validation Group (TVG). This government-enabled organisation includes expertise from the UK Health Security Agency, Covid-19 National Diagnostic Research and Evaluation Platform, Innovate UK, Royal College of Pathology, and the Medicines and Healthcare products Regulatory Agency. The TAG confirmed that both new assays meet the diagnostic performance criteria for both sensitivity and specificity.

Dr Helen Lee, chairman and CEO of DRW, said: “Our team is focused on developing and delivering practical near-patient solutions that provide the highest value at the greatest point of need. From our ongoing Covid-19 testing work in the NHS and in discussions with hospital staff, the requirement for fast, accurate multiplex respiratory virus tests for use in clinical practice was clear and urgent.

“These new tests deliver on the first stage of our plan to expand our menu of tests available on the SAMBA II platform – supporting rapid, efficient and accurate diagnosis of multiple infectious diseases, aiding clinical decision-making, and enabling improved, timely access to healthcare for all.”

Diagnostics for the Real World, which was formed in 2003, is based on the Science Village at Chesterford Research Park.

Dr Ravi Gupta – Professor of Clinical Microbiology at the Cambridge Institute for Therapeutic Immunology and Infectious Disease – led the initial validation of the SAMBA II SARS-CoV-2 rapid point-of-care test at Addenbrooke’s Hospital in 2020, demonstrating that the SAMBA system was able to deliver highly accurate results ten times faster than other diagnostic tools. Commenting on the launch of DRW’s two new multiplex tests running on the SAMBA platform, he said: “With COVID remaining an ongoing challenge, prompt differential diagnosis of respiratory viruses continues to be extremely important for effectively managing patient care pathways and workflows in hospitals – from reducing the requirement for COVID ‘holding areas’ on admission and enabling faster triage, to freeing up much-needed beds on wards and allowing safe discharge to out-of-hospital settings, including to care homes. DRW’s new multiplex tests will be welcomed by clinicians as a key tool to help speed access to urgent care, crucially emergency surgery and transplantation, where delays and co-infections can have very significant adverse impacts.”

Dr Helen Lee, Chairman and CEO of DRW added: “Our team is focused on developing and delivering practical near-patient solutions that provide the highest value at the greatest point of need. From our ongoing COVID-19 testing work in the NHS and in discussions with hospital staff, the requirement for fast, accurate multiplex respiratory virus tests for use in clinical practice was clear and urgent. These new tests deliver on the first stage of our plan to expand our menu of tests available on the SAMBA II platform – supporting rapid, efficient and accurate diagnosis of multiple infectious diseases, aiding clinical decision-making, and enabling improved, timely access to healthcare for all.”

Diagnostics for the Real World Ltd (DRW) is the innovator of the Simple AMplification-Based Assay (SAMBA) platform for rapid point-of-care detection of infectious diseases – the simplest and most robust molecular diagnostic systems available today. DRW’s vision began in serving the large, unmet need for near-patient diagnostics in resource-limited regions of the world, pioneering innovative, high-performance, easy to use solutions that work in “real world” settings and supporting clinical services for people in real need. Today, DRW’s mission has expanded to meeting growing healthcare needs across the globe, delivering the advantages of decentralised point of care testing and treatment monitoring whenever and wherever they are needed most.

DRW’s high-performance SAMBA systems are providing a fast, accurate and cost-effective method for testing and diagnosis, and an accessible platform for transforming healthcare and health outcomes.