POINT-OF-CARE DIAGNOSTICS


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


Post-partum haemorrhage (PPH)


Blood loss ≥ 500mL after the delivery or within the first 24h (or 1000mL during a caesarian section)


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).


PPH incidence


1 – 10% of pregnancies Severe PPH


(blood loss ≥ 1000mL): 2%


Leading cause of maternal mortality and morbidity worldwide


127,000 deaths annually


Aiding rapid decision-making The qLabs FIB system includes a handheld ElectroMeter and dry-reagent test strips. It measures fibrinogen levels from a single drop of whole blood; and has expanded the company’s near-patient testing portfolio for the critical care setting. Designed for ease of use and speed, the device delivers results in ≤10 minutes, with a hands-on time of <60 seconds (Fig 3).4 Further, with qLabs FIB, the lower a


patient’s fibrinogen level, the faster the result, which aids in rapid decision-making and administration of fibrinogen products to manage coagulopathic bleeds due to hypofibrinogenaemia during PPH5 pre-hospital trauma settings.


and in The time saved when using qLabs FIB


compared to the time involved in sending a sample to the laboratory and waiting for a fibrinogen result is significant. Long laboratory turnaround times can result in inappropriate or unnecessary allogenic blood product transfusion, which may lead to further clinical complications for the patient.


Stago also sees opportunities to use qLabs FIB outside the immediate hospital critical care setting, such as by NHS paramedics when assessing the cause of bleeding. This enables advance warning to be given to emergency department and surgical teams.


FIBRINOGEN


1st factor to decrease Early warning of PPH Predicts severity (<2 g/L)


Fig 1. Post-partum haemorrhage and fibrinogen 35


Fibrinogen / Clauss method


Gold standard for fibrinogen dosage Tube to laboratory results = 30-60 minutes Timescale not appropriate for PPH


Ms Haseena Halai, UK Business Development Manager, Stago POC Solutions, explained: “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. Any delay in obtaining coagulation test results from a central laboratory makes it harder to control bleeding during or immediately after surgery and in trauma situations.


JUNE 2023 WWW.PATHOLOGYINPRACTICE.COM


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