Diagnostica Stago is launching qLabs FIB - a novel POC device which measures fibrinogen levels from a single drop of whole blood, further expanding the company’s near-patient testing solutions for the critical care setting.
Fibrinogen is crucial for clot formation and has a significant impact on clinical outcomes in major bleeding. Low levels are linked to acquired or inherited fibrinogen deficiency, liver disease, abnormal fibrinolysis, and haemorrhage. They are also the first sign of post-partum haemorrhage (PPH), the leading cause of maternal deaths during childbirth.
Haseena Halai, UK Business Development Manager, Stago POC Solutions, explained: “Fibrinogen is critical to haemostatic management of bleeding patients. When time is critical, having access to a near-patient testing device that can measure declining fibrinogen levels within a few minutes can make a difference to patient outcomes. The lower the fibrinogen level, the faster qLabs delivers its result, enabling clinicians to give the right products at the right time.”
Fibrinogen is a glycoprotein synthesised in the liver and present in plasma at a concentration of 2-4g/L. The interaction between thrombin and fibrinogen creates insoluble cross-linked polymer fibrin which can stop blood flow.
The qLabs FIB test shows a strong correlation with Stago’s STA-Liquid Fib Clauss fibrinogen assay, with a correlation coefficient of 0.985, an intercept of 0.034 and a slope of 1.006 (n=98).
The device provides automatic haematocrit adjustment (within a 20-60% range). Its ready for use, dry reagent strips can be stored at room temperature for up to 24 months. It also has a built-in QR code scanner, as well as ports for printers and computer networks, and an optional docking station.
Ms Halai also sees opportunities for the use of qLabs outside the immediate hospital critical care setting, for instance, used by NHS paramedics when assessing the cause of bleeding and giving advance warning to surgical teams. “The qLabs device offers robust, consistent results comparable to a lab-based Clauss fibrinogen assay whether it is used for near- patient emergency testing in the community or to provide urgent bleeding assessment in the operating theatre,” she added.
The touchscreen handheld device complements Stago’s Quantra POC viscoelastic testing system. On the Quantra, fibrinogen is just one of six parameters for guiding blood product transfusion. The Quantra system is already being used in one of the country’s leading NHS cardiac centres.