Biotech firm receives CE mark approval for rapid COVID-19 test

British biotech firm MicrosensDx has received CE mark certification for its RapiPRO LAMP SARS-CoV-2 test.

The molecular diagnostics innovator with a 20-year history in IVD development, is an expert in Loop-mediated Isothermal Amplification (LAMP) testing, having developed tuberculosis (TB) diagnostics using the technology.

MicrosensDx has revealed testing data for its rapid new test which has been validated to demonstrate 97.4% sensitivity and 96.0% specificity in detecting SARS-CoV-2, returning a result in less than 30 minutes. This performance is in both symptomatic and asymptomatic patients, and across the full range, from low to high viral load.

The test has been successfully trialled with a private laboratory partner, offering symptomatic and asymptomatic screening programmes on large industry sites, Department of Health and Social Care (DHSC) settings, and Test-to-Release schemes.

RapiPRO LAMP SARS-CoV-2 is highly scalable. It can be configured to run in high throughput laboratories, including those currently configured for polymerase chain reaction (PCR) testing. It has been validated on multiple platforms, including Genie II, Genie III and Genie HT, allowing eight, 16 or 96 samples to be analysed at one time. Imminent further platform rollout is also planned.

The test can also be deployed in a close to patient format and can be performed by a healthcare technician with minimal training. This on-site capability may be attractive to airport and leisure venue operators, who are looking for the COVID-19 detection that LAMP technology is able to provide.

RapiPRO LAMP for SARS-CoV-2 can amplify the RNA of a sample derived from any CE marked nucleic acid extraction kit, but it has been designed synergistically to complement MicrosensDx RapiPREP extraction technology. 

RapiPREP uses patented magnetic bead technology to extract the RNA from a nasal swab sample. Crucially, this technology removes the need for organic solvents, isopropanol or ethanol and also the centrifuging commonly associated with traditional extraction methods, making the process faster, cheaper, and more sustainable.

Additionally, any live virus is neutralised once captured in the RapiPREP Viral lysis buffer, rendering it safe for the technician administering the test.

Dr Mark Street-Docherty, CEO at MicrosensDx, said: “Rapid, accurate testing remains vital to the COVID-19 response, even as vaccine rollout gathers pace around the world. LAMP tests offer greater speed than PCR tests and greater sensitivity than lateral flow antigen assays. Our RapiPRO LAMP SARS-CoV-2 test is highly sensitive, (97.4%) and highly specific (96.0%). It has been successfully deployed on largescale industrial sites, DHSC settings and in Test-to-Release schemes, to conduct the validation. 

“We’re very pleased to announce the CE marking and are now scaling production in the UK, in addition to actively discussing new partnerships with international distributors and technology partners as we roll out the test in new territories.”

As well as COVID-19, the RapiPRO LAMP technology has the potential to detect multiple pathogens, such as norovirus, respiratory syncytial virus (RSV) or influenza. The ability to quickly and accurately detect these other diseases has real potential to assist in expeditious diagnosis and help to control outbreaks at their onset.