QuickFib – A rapid test for determination of fibrinogen for the targeted treatment of fibrinogen deficiency states
The blood coagulation is an essential process that is precisely controlled in the body to avoid both blood loss and thrombosis. During coagulation fibrinogen is converted to fibrin that aggregates to form a blood clot and thus stops the bleeding. During bleeding events, the plasma concentration of fibrinogen decreases much faster than that of all other coagulation factors. The resulting fibrinogen depletion may be life-threatening and lead to bleeding death.
The project team has developed a concept for an enzyme-based rapid test to determine the fibrinogen concentration in 2-5 minutes. The goal of the Pioneer Project is the development of a reliable rapid test on the basis of cuvettes. Such a test is the starting point for the further development of a marketable test strip with a corresponding reading device with digital output which is licensed as in-vitro-diagnostics according the Medizinproduktegesetz (German federal law for medical devices).
Fast analysis of the plasma level of fibrinogen in bleeding patients can save lifes.
The beginning of a targeted treatment of patients with fibrinogen deficiency is time-critical. The longer the deficiency remains undetected and untreated the higher can be the blood loss, which increases the chance of a likewise risky blood transfusion. A large number of clinically relevant blood-clotting disorders can be treated with fibrinogen preparations, provided that the fibrinogen deficiency is detected in time. This is demonstrated by the following examples:
• Victims in traffic accidents: There is no time to wait for the result of the current, comparably slow laboratory diagnostics. Without analytical results patients may be treated needlessly with costly concentrates and the risk of thrombosis will be unnecessarily increased. Alternatively no fibrinogen is applied for economic reasons although it would have been life-saving.
• Bleeding complication during child-birth: In these cases, the fibrinogen plasma level decides over the severity of potential complications that can be easily countered with fibrinogen. In developing countries, with no laboratory equipment available, fibrinogen concentrates are too expensive to give them prophylactically leading to bleeding death of many women. Here, a fast and cost-effective detection method for fibrinogen could save lives.
There is an urgent need for a rapid test with high precision in the relevant concentration range.
Available laboratory tests take 23 minutes on average; faster tests do not provide the sufficient precision in the relevant concentration range. Currently available devices for fibrinogen analysis in the blood are expensive and therefore only available in large hospitals. However, the correct dosage of fibrinogen in cases of high blood loss is also desirable in small hospitals. An easy-to-handle rapid test for fibrinogen following the example of commercially available point-of-care tests for blood glucose could expand the treatment of fibrinogen deficiency to these areas.