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UK NEQAS for Blood Coagulation D-Dimer Point of Care Testing Programme: A Review of Data

D.P. Kitchen, L. Brown, S. Munroe-Peart, A. Lowe, I. Jennings, S. Kitchen, I. Walker

UK NEQAS for Blood Coagulation, Sheffield, United Kingdom

Abstract Number: PB0518

Meeting: ISTH 2020 Congress

Theme: Diagnostics and OMICs » Laboratory Diagnostics

Background: In May 2014 UK NEQAS BC introduced a POCD-dimer programme.n= 106
(Roche Cobas h232=67 and Quidel Triage=39).

Aims: To provide external quality assessment (EQA) to POC D-dimer testing.

Methods: Samples are lyophilised citrated plasma with a pre measured volume of diluent and a disposable pipette such that no laboratory equipment is needed. A patient scenario is also provided and users are required to choose either “no further investigation required” or “further investigation required” based on their local test result. This post analytical aspect is scored if there is a consensus of 80% or more . Peer group performance assessment is undertaken. Median values are calculated and the furthest 10% from the median (both higher and lower) are considered “outwith consensus”. If a centre has 3 outwith consensus surveys consecutively they will be classified as “persistently outwith consensus” and receive contact from the programme director.

Results: Results are shown in tables 1 and 2.A small number of centres have given interpretations that were inappropriate based on their results. One centre had a result of 0.74ug/ml FEU and stated “no further investigation”, manufacturers stated cut off is 0.5ug/ml FEU. For samples that were provided with a patient scenario of a Wells score of 3 or 4 a small number of centres stated no further investigation required. ie they had results of below the cut off but did not take into account the provided high Wells score.

Conclusions: EQA is essential for D-dimer testing whether in the laboratory or in a POC setting. The interpretations of these results overall was good but some centres did not take into account the patient scenario provided. We have also seen results which are over the manufacturers stated cut off which have been deemed by the user to not require further investigation.

Table 1 Survey Triage median ng/ml FEU Triage interpretation % Outwith consensus results % Outwith consensus interpretation CV%
16 296 89.5% no further investigations 8.7 10.5 17.4
17 443 Not scored 14.7 not scored 13.2
18 402 Not scored 16.1 not scored 23.4
19 1810 100% Further investigations 18.9 0.0 25.2
20 597 88.9% Further investigations 15.1 2.0 18.1
21 100 93.3% no further investigations 0.0 6.7 Not applicable
22 357 Not scored 15.2 Not scored 27.4
23 1400 100% Further investigations 17.1 0.0 17.5

[Table 1 Data shown for the last 2 years for Triage users]

Table 2 Survey Cobas h232 median ug/ml FEU Cobas h232 interpretations % Outwith Consensus results % Outwith Consensus interpretation CV%
16 0.25 89.9% No further investigations 19.6 10.2 20.1
17 0.25 100% No further investigations 14.5 0.0 17.3
18 0.23 Not scored 9.3 not scored 17.1
19 1.52 98% Further investigations 16.7 2.0 23.4
20 0.36 92% No further investigations 14.0 8.0 15.6
21 0.1 89.4% No further investigations 1.9 10.6 31.5
22 0.37 91.5% No further investigations 17 8.5 24.1
23 0.995 98% Further investigations 18.3 2.0 19.7

[Table 2 Data shown for the last 2 years for Cobas h232 users]

To cite this abstract in AMA style:

Kitchen DP, Brown L, Munroe-Peart S, Lowe A, Jennings I, Kitchen S, Walker I. UK NEQAS for Blood Coagulation D-Dimer Point of Care Testing Programme: A Review of Data [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/uk-neqas-for-blood-coagulation-d-dimer-point-of-care-testing-programme-a-review-of-data/. Accessed October 1, 2023.

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