Renfrew Group assist MicrosensDx with the design and development of its Coronavirus COVID-19 RapiPrep® test cartridge.
MicrosensDx announces first clinical results of its rapid testing kit for SARS-Cov-2
Renfrew Group assist MicrosensDx with the design and development of its Coronavirus COVID-19 RapiPrep® test cartridge.
MicrosensDx announces first clinical results of its rapid testing kit for SARS-Cov-2
On 20th March MicrosensDx announced that it had launched its fast and safe molecular test for research use in the detection of RNA from the SARS-Cov-2 virus in sputum, throat and nose swabs.
MicrosensDx can now announce that the test has been assessed for clinical performance using patient samples from 21 residents in a London care home in collaboration with a London University and a major London hospital. Both nose and throat swabs from COVID-19 positive and negative patients were used to assess the performance of the prototype RapiPrep®COVID-19 clinical diagnostic test against the standard laboratory PCR tests run in the London hospital supporting the trial. The study will be reported shortly in the scientific literature but in brief the new RapiPrep® COVID-19 test was found to be “fast, easy to use and to work equivalently to RT-PCR methods” by the academic and medical staff involved in the trial. These clinical results form part of the validation data that will allow MicrosensDx to complete the CE marking process to allow the company to launch the test as a clinical diagnostic product in April.
Whilst standard laboratory PCR tests for detecting the virus can take about 4 hours from receipt of sample, in practice the logistics of shipping the swab to a centralised lab and batching the samples means that results are often reported next day. By 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.
A CE marked version of the RapiPrep® COVID-19 test will be available in April in a point of care, ‘patient-side’ cartridge format (intended for small laboratories or clinics carrying out up to 50 samples per day – see image above). MicrosensDx is also now engaged in developing a high throughput version for the larger testing laboratory that will be suitable for automation using standard liquid handling robots.
MicrosensDx CEO, Dr Christopher Stanley, commented: “Our RapiPrep® COVID-19 test kit has been clinically validated 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 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.
Contact: Claire Thompson on behalf of MicrosensDx
claire.thompson@agilityhealthtech.com / +44 (0)7885 591 187 / www.microsensdx.com