Assessing critical bleeding: quality and governance standards

Fibrinogen is an essential part of the blood clotting process, and testing aids decision-making in critical care situations, notably post-partum haemorrhage. A novel POCT device now brings this to near-patient settings, but, for such a vital test, accuracy and quality control are key, as Pathology in Practice explains.

Worldwide, post-partum haemorrhage (PPH) is the leading cause of death during childbirth, and declining fibrinogen levels can be the first sign.1,2 The interaction between thrombin and fibrinogen creates fibrin, the insoluble cross-linked polymer needed for successful haemostasis. Fibrinogen is the final essential building block of the clotting process with a significant impact on clinical outcomes when major bleeding occurs (Fig 1).

Against this background, it should be no surprise that the assessment of coagulation status, and fibrinogen testing in particular, is a prime candidate for the application of point-of-care testing (POCT).3 This provides a number of benefits both for patients and the healthcare service in general, as it aids clinical decision-making when clinicians are faced with critical haemorrhage, resulting in the need for immediate patient management and treatment.2

Recently, leading haemostasis company Diagnostica Stago launched qLabs FIB, a novel POC system for monitoring functional fibrinogen. This gained UK Medical Device Regulation (MDR) approval as an in vitro diagnostic device in September 2022 (Fig 2). 

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