London, 20th March 2020
With the imminent threat of the coronavirus (SARS-CoV-2) forcing countries worldwide into lockdown and putting a severe strain on healthcare services, MicrosensDx has responded by adapting its current range of infectious disease rapid detection kits to create a coronavirus detection product, suitable initially for research use.
The MicrosensDx RapiPrep® system enables highly sensitive SARS-CoV-2 detection in less than 25 minutes from taking a sample to test result. The portable, desktop kit will be used initially in scientific laboratories involved in vaccine and therapeutic research and development.
MicrosensDx is now engaged in a programme to gain CE accreditation for the SARS-CoV-2 test which will permit its sale and use in the diagnosis of the COVID-19 disease. The CE-marked kits will provide rapid ‘on demand’ testing support alongside the large-scale hospital laboratory testing instruments and will also allow disease testing to take place in facilities such as clinics, doctor’s offices and in the workplace.
The key features of the RapiPrep® SARS-CoV-2 research use test are:
- Any sample type is suitable: Including virus-containing culture media and tissue, clinical samples such as throat, nasal, sputum, faeces.
- Rapid detection time: Less than 25 min to result.
- Detection method: Detection of the viral RNA genome based on the MicrosensDx modified LAMP nucleic acid amplification technology, which is already in routine use in the company’s tuberculosis and norovirus clinical diagnostics products.
- Accuracy: The RapiPrep® system incorporates the company’s proven magnetic bead-based virus extraction technology that gives enhanced sensitivity over other testing methods.
- Reliability: The modified LAMP method incorporates procedure controls to prevent false negatives, which will be of critical importance in the future CE-marked test.
- Safety: Immediate virus inactivation takes place inside the test cartridge.
- Easy to operate: Three simple steps, suitable for semi-skilled operators.
- Automated detection: The instrument has visual representation of test result and confirmation that the procedure control has run successfully.
The RapiPrep® system will be undergoing clinical assessment imminently within the UK to demonstrate its value as a rapid COVID-19 screening tool.
MicrosensDx CEO, Dr Christopher Stanley, commented: “Our RapiPrep® system will enable rapid, sensitive and specific detection of SARS-CoV-2 by the research community and when CE-marked will permit highly effective screening of patient samples in hospitals and in the community. This will allow more informed decision-making on disease containment and delay methods, whether that be treatment or self-isolation. We are confident that this technology when launched for clinical use can make a significant impact on flattening the outbreak curve and reducing the enormous burden on the healthcare system.“