Quantify Ferritin levels
Radisens Diagnostics is developing a professional-use only, point-of-care in-vitro diagnostics platform – Gemini™ – to quantify Ferritin levels in at-risk blood donors before blood donation. Gemini™ consists of an optical-based reader which automatically tests a latex enhanced homogeneous Ferritin immuno-assay on a single-use microfluidic cartridge. Gemini™ requirements include:
- High sensitivity Ferritin test to quantitatively measure low concentrations of iron stores,
- Rapid time-to-result of <8 minutes,
- A 25-30µL fingerstick sample of whole blood,
- Room temperature storage for up to 12 months, eliminating the need for cold chain facilities.
Point-of-care Ferritin test
The point-of-care Ferritin test uses a novel centrifugal microfluidic cartridge approach combined with proprietary dried reagent assay protocols based on immuno-turbidimetric principles. Gemini™ leverages the many advantages of centrifugal microfluidics such as controlled liquid transport, metering, plasma separation, valves, dried reagent rehydration and mixing.
Concentrated antibody-coated latex and buffer reagents are formulated and dispensed onto the microfluidic cartridges and subjected to a proprietary multi-parameter controlled reagent drying process. These reagents are being optimized to enhance the low-end sensitivity of the Ferritin test for the blood donor use case while maximizing their stability for storage at room temperature. Radisens’ approach is to take bulk reagents used in laboratory analyser tests, reformulate them and introduce them into a cartridge in a concentrated dried state. This reduces the reagent development risk by leveraging existing commercial reagents.
Comparison data for Ferritin
Radisens Diagnostics has in-house expertise in developing dried reagent immunoturbidimetric and clinical chemistry assays. Early method comparison data for Ferritin is shown below. Other immunoturbidimetric tests demonstrated on Gemini™ include glycated haemoglobin (HbA1c) and C-reactive protein (CRP). Enzymatic clinical chemistry tests for Lipids and Creatinine have also been demonstrated.
Similarly, Radisens Diagnostics has expertise in microfluidic cartridge design based on centrifugal microfluidic principles, cartridge prototyping using micromachining, design for manufacture, hardened steel tool design, injection moulding of proof-of-principle cartridges and point-of-care reader development.