30May

Diagnostics for the Real World (DRW) achieves UK technical validation for two multiplex respiratory virus rapid tests

Diagnostics for the Real World Ltd (DRW), innovator of the SAMBA platform for rapid point-of-care detection of infectious diseases, today announces that it has achieved UK technical validation for two multiplex respiratory virus tests (SARS-CoV-2/FluA/FluB and SARS-CoV-2/RSV) that deliver a vital tool for NHS care teams. The new combined tests enable clinicians to rapidly detect and differentiate between coronavirus SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) – boosting infection control in hospitals, optimising patient management and speeding access to urgent care services, including emergency surgery. The Technical Validation Group (TVG) confirmed that both new assays meet the diagnostic performance criteria for both sensitivity and specificity. This is the classification with the highest level of performance, requiring no confirmatory testing. Further data has also been submitted for the purpose of the fulfilling the UKHSA’s new criteria through the Coronavirus Test Device Approvals desktop review.

 

The CE-marked multiplex tests provide highly accurate results via the SAMBA II platform – DRW’s fully automated ‘sample in, result out’ diagnostic machine, which is currently deployed in over 100 UK hospital sites as one of the NHS’s primary point-of-care, non-lab-based COVID-19 testing solutions. The two new multiplex tests will be available to NHS hospitals and healthcare settings.

 

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 coronavirus SARS-CoV-2 is combined with influenza A and B in the SARS-Cov-2/FluA/FluB multiplex test, and with the respiratory syncytial virus (RSV) in the new SARS-CoV-2/RSV multiplex test. The SAMBA II SARS-CoV-2/FluA/FluB Test specifically amplifies one region of the SARS-CoV-2 genome in the ORF1ab, one region of Influenza A genome in the matrix protein, and one region of Influenza B genome in the non-structural protein. The SAMBA II SARS-CoV-2/RSV Test specifically amplifies two regions of the SARS-CoV-2 genome in the ORF1ab and nucleocapsid protein (N) and one region of respiratory syncytial virus (RSV) genome in the non-structural protein 1.

 

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.”

 

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 1-2 day 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.

 

Ends---

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