Point-of-Care Test Development Services
Support for Total POCT developments, pre-feasibility studies, optimization, verification and validation
Future Diagnostics has over 15 years of experience in quantitative Point-of-Care (POC) test developments on several devices/technologies. For this reason, Future Diagnostics is the obvious choice to assist companies with POC test- and platform developments. You can benefit from our POC knowledge on whole blood, dry-chemistry, nano-technology, and magnetic beads.
Point-of-Care testing is a fast growing specialty within the in vitro diagnostics market. POC tests decrease turnaround time (TAT) and therefore improves patient care by near-patient testing. You can think about rapid diagnosis at the emergency rooms or operating theaters at hospitals, medical specialist's offices, general practitioner's offices or in the ambulance. No more delays in treatment decision making and at the same time no unnecessary anxiety for patients. Besides efficiency, technologies improve fast on precision, reliability and accuracy. In conclusion, the right POC device can deliver lab-equivalent results within 8 - 30 minutes.
Outsource your Point of Care Test Development
Compliant with regulatory guidelines, enabling complicated set-up of POC infrastructures
Future Diagnostics develops quantitative Point-of-Care Tests on devices of a customer's choice. Nevertheless, if the customer is in doubt on choosing the best POC device for their test, our advice is considered valuable. Based on the customer's wishes and requirements, we give an independent and well thought out advise on choosing the best device for their test.
Besides support on choosing a POC device, Future Diagnostics provides support on making important decisions on critical parameters to start a successful Point-of-Care test development. Critical parameters that may affect the success of a test are e.g. reagents and materials. Critical parameters are optimized by continuously monitoring ongoing processes during developments. Active monitoring of critical parameters enables a final precision that is equal compared to the large analyzers in the central laboratories.
In general, Point-of-Care tests require only a single drop of biological samples, such as whole blood, saliva or urine. Very low concentrations (pico molar) target substances are measured in a matter of minutes. We are able to convert whole blood immediately to plasma within the cartridge. This is based on the long lasting experience we have on the handling of blood and the usage of filters.
Point-of-Care tests based on dry chemistry are realized by a cutting-edge technology. It eliminates the usage of liquid reagents within a Point-of-Care device by applying dry reagents onto the POC cartridge. One advantage of dry chemistry is that dilution of the biological sample is prevented, since 'wet' solutions are omitted. Drying reagents on cartridges and at the same time keep the reagent's features are special skills of our assay developers. Equally important, the dried reagents on the cartridge need to have the ability to get reconstituted within seconds. This is another way of making pico molar sensitivity possible with POC applications.
Nano-Technology is the engineering of functional systems with novel properties at nanoscale. Building POC assays from the bottom up with atomic precision is what our assay developers do best.
The beads used in Point-of-Care tests are in general smaller than 1 micrometer in diameter. They are coated with antibodies or analytes that capture the target molecules. We work with numerous commercially available beads (also called particles or microspheres). We evaluate and select the most optimal beads to use. Magnetic- or gold beads are preloaded into the cartridge. They automatically disperse into the sample as the cartridge fills with the applied biological sample.
Lateral Flow is an easy-to-use Point-of-Care technology that detects the presence or absence of target molecules. In essence, it is a qualitative assay. Nevertheless, sensitive detections are evolving and more quantitative Lateral Flow devices come to market. It is important to consider how precise the outcome of a test has to be. In conclusion, if you consider to develop an assay on Lateral Flow, Future Diagnostics is also the obvious choice to contact for development support.