Evaluation of EQA material on Yumizen G200 – coagulation analyser: UK NEQAS for Blood Coagulation study

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Figure 1: Yumizen G200

Figure 1: Yumizen G200

L Brown, DP Kitchen, I Jennings, S Munroe – Peart, S Kitchen, T A L Woods, I D Walker
UK NEQAS for Blood Coagulation, 3rd Floor Pegasus House, 463 A Glossop Road, Sheffield, S10 2QD, UK

Main finding:

The study has shown that UK National External Quality Assessment Scheme for Blood Coagulation (NEQAS BC) external quality assessment (EQA) lyophilised plasma samples can be tested on Yumizen G200 device.

 

Background

  • Yumizen G200 is a two channel analyser for in vitro testing (Fig.1)
  • Uses citrated plasma
  • Performs coagulation screening tests, clotting factor assays, D-Dimer and Antithrombin 

 

Aims

To determine the suitability of UK NEQAS BC lyophilised plasma samples for use with Yumizen G200.

 

Methods

  • UK NEQAS BC samples previously used in the laboratory EQA programme were selected.
  • For each tested parameter (PT/INR, APTT, Fibrinogen, Thrombin Time and DDimer) 5 aliquots of each of three samples (low, normal, high) were tested on the Yumizen G200 using reagents provided by the manufacturer.
  • Obtained results were compared to the test specific medians established previously in UK NEQAS BC EQA surveys.

 

Results

For INR, PT APTT, Clauss fibrinogen, thrombin time and D – Dimer mean results obtained on Yumizen G 200 were comparable to the test specific median values of UK NEQAS BC EQA samples attaining a range of coefficient of variation (CV%) 1.3 – 7.8. For more detailed results refer to table 1.

Tested parameters and type of 
samples used
Yumizen G200
mean (CV%)
UK NEQAS
samples median
INR1.6 (1.8)1.34
INR2.5 (3.6)2.3
INR5.6 (3.2)5.27
PT (ratio) (FV deficient plasma)1.5 (2.3)1.29
PT (ratio) (FX deficient plasma)1.6 (1.3)1.57
PT (ratio) (FVII deficient plasma)1.8 (2.4)1.84
APTT (ratio) ( NP)1.11 (3.3)0.98
APTT (ratio) (FXI deficient plasma)1.48 (4.8)1.25
APTT (ratio) (VWF type 3)2.19 (1.5)1.91
Clauss fibrinogen g/l2.02 (5.5)1.87
Clauss fibrinogen g/l2.52 (5.6)2.4
Clauss fibrinogen g/l3.94 (7.2)3.9
DDimer (ug/ml FEU)0.68 (7.8)0.63
DDimer (ug/ml FEU)0.4 (2.8)0.39
TT (ratio) (NP)0.98 (1.2)1.01
TT (ratio) (Dabigatran x 28ng/ml)> 6.44.87
TT (ratio) (UFH x 0.15 u/ml)1.41 (3.0)1.45
APTT (ratio) (Lupus pos.)1.34(4.0)DRVVT 1.74
APTT (ratio) (Lupus pos.)1.85 (2.7)DRVVT 2.84

Table 1. Obtained results.
(NP =normal plasma, UFH= unfractionated heparin, TT = thrombin time, VWF type 3 = Von Willebrand factor type 3)

 

Conclusion

The study has demonstrated the suitability of UK NEQAS BC EQA lyophilised plasma samples for testing on Yumizen G200.

Device Yumizen G200 and reagents were provided by Horiba Medical. No funds were received by UK NEQAS BC to carry out this study.

 

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