PB0616 - UK National External Quality Assessment Scheme for Blood coagulation (UK NEQAS BC) evaluation of the point of care fibrinogen device

Background: UK NEQAS BC provide external quality assessment (EQA) for haemostasis tests across both laboratory and point of care (POC) setting. Currently we have over 1200 laboratory sites and over 4600 sites registered for POC tests which include INR, ACT, D-dimer and viscoelasticity testing. When new tests are introduced into laboratories or POC we endeavour to provide EQA for these tests.

Aims: qlabs®FIB monitoring system is a POC fibrinogen device for use with whole blood samples and is distributed by Stago. We aim to establish whether UK NEQAS BC lyophilised plasma samples were suitable to use as EQA.

Methods: 6 lyophilised plasma samples that had previously been distributed to over 800 laboratory sites were tested on the qlabs®FIB monitoring system For each plasma sample the median Clauss fibrinogen result obtained from participants in the laboratory fibrinogen programme was compared to results obtained by duplicate testing of the same sample on the qlabs® FIB monitoring system. A comparison of citrated whole blood sample tested on the qlabs® device to citrated plasma tested in the local laboratory for Clauss fibrinogen using Siemens thrombin and the Sysmex CS5100.

Results: All qlabs® FIB monitoring system were within 0.1g/L of the corresponding median value on laboratory testing mean values of 2.64 (UK NEQAS BC all users) and 2.65 on qlabs® FIB monitoring system. Two samples were chosen from the panel of 6 for further precision testing. 10 tests were completed by 3 operators and on different days. Coefficients of variance (CV) for these 2 samples were 4.7% and 3.1% showing good agreement. . Results of comparison between laboratory method and the POC method on patients’ samples (n=23) showed reasonable agreement (paired t test p=0.75) with mean values of 2.61 and 2.55 respectively.

Conclusion(s): We conclude that UK NEQAS BC could provide suitable EQA material for the qlabs® FIB monitoring system.