POINT-OF-CARE DIAGNOSTICS NEQAS


Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6 Mean


samples tested media value g/L g/L 2.01


2.47 2.52 2.68 2.95 3.4


2.67


UK NEQAS BC qlabs FIB system Difference from median g/L


2.045 2.565 2.455 2.64 2.88 3.31 2.64


0.035 0.095 -0.065 -0.04 -0.07 -0.09 -0.02


Table 1 (above). Comparison with NEQAS media values: Samples from qLabs FIB were tested in duplicate and compared to the median value obtained from testing by over 88 laboratories using a range of reagents. Table shows the average of the duplicate versus median result from value when the sample was distributed in a NEQAS exercise. Table 2 (right). Precision testing: Samples 1 and 6 were further tested 10 times to establish precision. Results show good precision with both samples showing coefficients of variance <5%.


laboratories. UK NEQAS BC therefore concluded that the system demonstrates good precision and shows comparable results with its EQA samples and therefore the scheme confirmed that it would provide an EQA service for this device.


Getting it right first time Point-of-care testing can play a pivotal role in the UK’s ‘Getting it Right First Time’ (GIRFT) approach,10


and this is particularly


relevant to fibrinogen testing supported by devices such as the qLabs FIB system from Stago. Blood transfusion rates can indicate how well a unit functions, with low rates associated with positive practices such as protocolised care across the entire unit and agreed transfusion triggers. As well as the cost of blood


products, there is strong evidence to show that allogenic blood product transfusion is associated with adverse patient outcomes, and therefore robust diagnostic support is essential prior to administration.11-14


It is, however, self-


evident that when faced with a major haemorrhage, rapid blood transfusion is essential to prevent death.


Coagulation testing using a system such as qLabs FIB that has been quality- assured by UK NEQAS BC and aligns to ISO 15189 governance standards provides a significant contribution to quality patient care and to the GIRFT initiative. This is particularly significant when dealing with PPH and its rapid onset.


References 1 World Health Organization. Trends in


Maternal Mortality 1990 to 2015. Geneva: WHO, 2015 (https://apps.who.int/iris/ bitstream/handle/10665/193994/WHO_ RHR_15.23_eng.pdf)


2 Toulon P, Ozier Y, Ankri A, Fléron MH, Leroux G, Samama CM. Point-of-care


37 Testing frequency


Vial 1 Vial 2 Vial 3 Vial 4 Vial 5 Vial 6 Vial 7 Vial 8 Vial 9


Vial 10 Mean


Sample 1 qlabs g/L results


NEQAS median = 2.01 1.94 2.15 2.19 1.97 2.02 2.04 2.05 2


1.92 2.17 2.05


Standard deviation 0.096 CV%


4.7


versus central laboratory coagulation testing during haemorrhagic surgery. A multicenter study. Thromb Haemost. 2009;101(2):394-401.


3 Cortet M, Deneux-Tharaux C, Dupont C et al. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012;108(6):984-989. doi:10.1093/bja/aes096


4 Bell SF, Kitchen T, John M et al. Designing and implementing an all Wales postpartum haemorrhage quality improvement project: OBS Cymru (the Obstetric Bleeding Strategy for Wales). BMJ Open Qual. 2020;9(2):e000854. doi:10.1136/ bmjoq-2019-000854


5 Okahara S, Handoh T, Wakita M et al. Fibrinogen measurement by a novel point-of-care device with whole blood: comparison of values against Clauss method. J Anesth. 2021;35(5):757-760. doi:10.1007/s00540-021-02987-9


6 Sanfilippo S, Buisson L, Rouabehi H et al. Evaluation of the qLabs FIB system, a novel rapid and easy-to-use point-of-care system to quantify functional fibrinogen level using a single drop of citrated whole blood sample. ISTH 2022 poster presentation abstract (https://abstracts. isth.org/abstract/evaluation-of-the-qlabs- fib-system-a-novel-rapid-and-easy-to- use-point-of-care-system-to-quantify- functional-fibrinogen-level-using-a-single- drop-of-citrated-whole-blood-sample/).


7 Surti R. POCT discovery project: strategic changes for primary care settings. Pathology in Practice. 2023 Feb;24(1): 27-9.


8 Bell SF, Collis RE, Pallmann PP et al. Reduction in massive postpartum haemorrhage and red blood cell transfusion during a national quality improvement project, Obstetric Bleeding Strategy for Wales, OBS Cymru: an


Sample 6 qlabs g/L results


NEQAS median = 3.3 3.3


3.32 3.07 3.12 3.14 3.22 3.39 3.29 3.26 3.3


3.24


0.101 3.1


observational study. BMC Pregnancy Childbirth. 2021 May 15;21(1):377. doi: 10.1186/s12884-021-03853-y.


9 Collins PW, Solomon C, Sutor K et al. Theoretical modelling of fibrinogen supplementation with therapeutic plasma, cryoprecipitate, or fibrinogen concentrate. Br J Anaesth. 2014 Oct;113(4):585-95. doi: 10.1093/bja/aeu086.


10 Richens D. Cardiothoracic Surgery. GIRFT Programme National Specialty Report. National Health Service 2018 (https:// gettingitrightfirsttime.co.uk/surgical_ specialties/cardiothoracic-surgery/)


11 Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. doi: 10.1111/j.1537-2995.2009.02518.x.


12 Snegovskikh D, Souza D, Walton Z et al. Point-of-care viscoelastic testing improves the outcome of pregnancies complicated by severe postpartum haemorrhage. J Clin Anesth. 2018 Feb;44:50-6. doi: 10.1016/j. jclinane.2017.10.003.


13 Jakobsen CJ, Ryhammer PK, Tang M, Andreasen JJ, Mortensen PE. Transfusion of blood during cardiac surgery is associated with higher long-term mortality in low-risk patients. Eur J Cardiothorac Surg. 2012 Jul;42(1):114-20. doi: 10.1093/ ejcts/ezr242.


14 McNamara H, Kenyon C, Smith R, Mallaiah S, Barclay P. Four years’ experience of a ROTEM-guided algorithm for treatment of coagulopathy in obstetric haemorrhage. Anaesthesia. 2019 Aug;74(8):984-91. doi: 10.1111/anae.14628.


Diagnostica Stago UK


0845 054 0614 stago-uk@stago.com www.stago-uk.com


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