London, 3rd April 2020
MicrosensDx is delighted to announce that the clinical study which validated its RapiPrep® COVID-19 clinical diagnostic test has been accepted for publication.
The study was conducted with leading research teams headed by Professor Tim Spector, Head of Department, Department of Twin Research & Genetic Epidemiology at Kings College London who also set up the COVID-19 symptom tracker app JoinZOE, and Dr Claire J Steves, Clinical Senior Lecturer at King’s College London and Consultant Geriatrician at Guys and St Thomas’s NHS Foundation Trust.
Professor Tim Spector commented: “We have been very excited by how the RapiPrep® COVID-19 test has performed in our clinical study, exceeding our expectations.
Its ability to rapidly and accurately test for infection at a point of care level has the potential to transform traditional COVID-19 detection methods.”
The clinical study assessed nose and throat swabs of 21 residents in a high dependency care home using the RapiPrep® COVID-19 test and compared the results with the current standard test reverse transcription polymerase chain reaction (RT-PCR). The standard laboratory RT-PCR tests for detecting the virus can take about 4 hours from receipt of sample. However, in practice, the logistics of shipping the swab to a centralised lab and batching the samples means that results are often reported the next day. In contrast, the new RapiPrep® COVID-19 test takes a maximum of just 30 minutes from swab to result and has been designed to be performed by operators with minimal scientific training.
The RapiPrep® COVID-19 test accurately detected 8/10 RT-PCR positive cases; where the test used only a single swab and the RT-PCR reference used two and identified a further 3 positive cases that were missed by RT-PCR. Eight cases were negative using both methods.
The study provided clinical validation of the RapiPrep® COVID-19 test kit as an effective rapid clinical diagnostic test that can be deployed in both patient-side and soon, in high throughput settings. It can detect active infections, where the individual is actually infected with the virus, in 30 minutes or less, even achieving a result in less than 10 minutes in samples with high viral load. This allows its use in rapid testing of frontline NHS staff and essential workers when placed in a minimally equipped laboratory setting with semi-skilled staff; it will also offer major advantages when used in high throughput laboratories where the speed of the test offers a substantial increase in productivity, this is of critical importance as the testing load in these laboratories is now rising rapidly.
MicrosensDx CEO, Dr Christopher Stanley, commented: “We are delighted with the outcome of the study and the impact that our RapiPrep® COVID-19 test could have in supporting the much needed increase in testing for coronavirus. Our kit is much faster than other existing or emerging kits, taking less than 30 minutes to detect COVID-19. Each test costs only a third of that of other existing or emerging detection kits.
We are scaling up our manufacturing so that the test kits can be deployed to the NHS, at a fraction of the current testing costs, and to care homes and mobile testing units in the community to detect disease early and prevent spread.”
A CE marked version of the RapiPrep® COVID-19 test will be available in the next 2 weeks in a point of care, ‘patient-side’ cartridge format, see image above. MicrosensDx is also developing a high throughput version for the larger testing laboratory that will be suitable for automation using standard liquid handling robots. The company is currently scaling up for the manufacture of both versions of the RapiPrep® COVID-19 kits to supply high throughput UK NHS laboratories and ‘on demand’ testing locations such as clinics, ER, care homes and other locations where simple laboratory capability can be installed.