MicroBioSensor currently has three products in development based on its underlying MicroBioSensor™ technology.
Our lead product, QuickCheck, is a point of care diagnostic for patients on peritoneal dialysis therapy. QuickCheck enables medical staff to instantly measure white blood cell levels in a patient’s dialysis effluent. For most patients, most of the time, QuickCheck will simply reassure that their white blood cell (leukocyte) levels are within normal bounds.
However, a higher leukocyte level, combined with other factors may be an indication of peritonitis. Dialysis effluent containing white blood cell counts of more than 100 cells / μL, indicates peritonitis, if present with symptoms or a positive bacterial culture, as set out in the International Society for Peritoneal Dialysis (ISPD) Peritonitis Recommendations.
QuickCheck is small and simple to use, and is suitable for use by clinical professionals outside clinical labs, providing a leukocyte count immediately.
The QuickCheck device is currently undergoing clinical assessment and is expected to be commercially available in the UK and the EU in late 2021.
A version of QuickCheck for use at home will enter clinical assessment for self-use by patients in late 2021, and would become available in 2022.
The STAR system has been developed to test urine samples from UTI patients for antibiotic resistance against five commonly used antibiotics.
A key component is the development of an optical reader for assessing the output of the device, which enables a readout within five hours, and appreciably reduces the size of the companion instrument. The STAR cassette has been designed to provide an automatic diluting function, to enable the device to be used by untrained workers in a care home pharmacy or GP clinic setting.
The cassette and optical reader designs are being finalised and tested by our design and prototyping partners Smallfry (Coventry), and Datalink Electronics (Loughborough).
A clinical assessment is underway to finalise the sample processing protocol ahead of a CE Mark clinical study scheduled for 2021.
PERIFAST: Peritoneal Fluid Antimicrobial Sensitivity Test
PERIFAST is a powerful in-clinic product, providing rapid antimicrobial sensitivity testing for patients arriving at hospital with peritonitis (either PD peritonitis or SBP). PERIFAST will be positioned alongside QuickCheck as an essential test for all patients arriving at clinic with suspected peritonitis.
The system is based around the STAR optical reader and cassette which will be adapted for use with a higher number of antibiotics. This R&D programme is ongoing, and the product will enter full clinical assessment in 2022.