ELISA (enzyme-linked immunosorbent assay) is a laboratory test for measuring small amounts of a substance in body fluids. It is a well understood and widely used technique which uses antibodies specific for the substance to be detected. Arquer has designed, manufactured and CE-marked an ELISA kit for Mcm5 for use in hospital path labs.
Arquer’s test detects and measures levels of Mcm5 in patients’ urine. The antibodies used in the test, and all operating parameters, have been derived to give the optimum balance of analytical sensitivity, ease of use and speed of operation.
In addition to the laboratory Mcm5 ELISA, Arquer is in the early stages of developing a point of care test for rapid diagnosis. The Company has recently developed a proprietary sample processing device and is currently evaluating a number of quantitative point of care platforms.
Arquer’s point of care system will comprise a robust reader instrument and disposable cartridges. A small volume of urine is placed in the device and a quantitative result appears within minutes. The reader is already developed and on the market for other critical diagnostic applications. The test is designed to be used in the urology clinic and the GP’s surgery.
Benefits of Point-of-Care Testing
There are clear advantages to both patient and clinician in avoiding the one or two-day wait for results from a central laboratory. Urine samples can be tested for Mcm5 along with other parameters when the patient arrives at the clinic so that all results are available to the clinician when the patient is examined. A worrying wait for the patient is eliminated. This also fits with the concept of the time and cost-efficient one-stop clinic. The concept of point of care, or near-patient testing, is gaining increasing acceptance. Most hospitals now have point-of-care co-ordinators who ensure that instruments are maintained and that users are appropriately trained. The robustness, accuracy and ease of use of Arquer’s point of care system have already been proved in exacting conditions in the field.
Established in 2007, Arquer Diagnostics Ltd (formerly UroSens Ltd) is based at the North East Business and Innovation Centre, Sunderland, UK. The management team and board of directors have extensive experience in the diagnostic market and the company is focussing on developing and commercialising urine-based immunoassay tests for cancers of the urinogenitary tract.