Ultra Rapid Plasma Preparation Platform
FABPulous has developed a proprietary manual method of ultra-rapid plasma preparation that can make a defined dilution of plasma from a small volume (few drops) of whole blood in seconds. The platform basis consists of two parts: a blood collector to absorb a small defined volume of blood from a finger prick, and a second small part that is docked onto the blood collector; this set-up allows for a pressure controlled filtration to produce diluted blood plasma (Figure 1). Sample volume and dilution factors can be adjusted as needed for subsequent testing with any, if not all, technology platforms for plasma derived targets. It can be integrated with a subsequent detection platform or it can prepare intermediary samples for these.
Figure 1. Rapid diluted plasma preparation device with collection container, as an example
By design, POC platforms are used to rapidly deliver near-patient test results in order to support optimization of disease management. Whole blood sample input in most immunoassay platforms often results in suboptimal test performance compared to plasma/serum sample input. Similarly, molecular diagnostic assays in whole blood samples for targets in plasma may benefit from the reduction of background nucleic acid from blood cells. Platforms using microfluidics cannot handle whole blood samples due to their design. Consequently the time to plasma preparation largely determines the overall time needed to produce a test result with many of the current POC tests. FABPulous’ ultra-rapid plasma preparation device prepares diluted plasma in seconds and can significantly reduce time to result, which carries high medical value, especially under circumstances that require urgent medical decisions.
Integrated Lateral Flow IVD Platform
Based on above described platform basis, the IVD test platform consists of two parts, i.e. the same blood collector as described earlier, and a cartridge that contains a filter stack as well as a lateral flow immunoassay strip (Figure 2).
Figure 2. IVD test platform: Consists of the blood collector and buffer compartment (blue-white part) and the cartridge which holds the filter stack and lateral flow strip.
The blood collector is docked onto the cartridge, after which the buffer contained in the blood collector is pressed in a controlled fashion through the advanced filter stack to produce diluted blood plasma, which subsequently is guided to a lateral flow strip to produce a final result in 5 minutes maximum.
Current state-of-the-art lateral flow assays on whole blood take 15-20 minutes at minimum to produce a test result. The IVD test platform developed by FABPulous allows for a threefold reduction in the time to result, as it produces a test result in 2-5 minutes. This rapid performance is of significant benefit in emergency situations where time is of the essence. In addition, it provides the general practitioner with a result within the time of a typical consultation, which is around 10 minutes.
Lastly, its simple and robust workflow serves the rapidly increasing market of home tests using whole blood, unlike with present state-of-the-art lateral flow technologies for whole blood.