Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds Anticoagulant Service

Transcription

1 Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds Anticoagulant Service

2 Leeds Teaching Hospitals Currently undergoing a Service Development Project Initiated PoCT in Clinics in 2012

3 Roche Coaguchek Pathology Managed Service Contract Siemens Xprecia Stride

4 Over 10,000 patients Stable patients Community Health Centres

5 Operate a Dose and Post service using venous blood samples

6 Moving towards a more patientfacing service using capillary sampling

7 Why use the Stride? Managed Service Ease of Use Cost

8 Purpose and Scope To compare the results of Siemens Xprecia Stride against ACL TOP and Roche Coaguchek XS Pro If suitable, to use in out-patient, community clinic and Home Visit settings to provide INR results

9 Number of Subjects Minimum 100 subjects Number of Sites Multiple sites both hospital and community Subject Eligibility Criteria Population 1: Subjects receiving warfarin treatment for 3 months or more Population 2: Subjects not receiving any anticoagulation therapy nor having a known coagulation disorder Population 3: Subjects being initiated on warfarin (ie less than 3 months on oral anticoagulation).

10 Acceptance Criteria Over the Measuring Range: Slope: 95% confidence interval within Intercept: +0.3 to -0.3 Coefficient of determination (r 2 ) 0.82 For range up to 6.0 INR: * Only applicable for data sets with n 10 in this INR test range The following statistics will be derived for a method comparison relative to the Xprecia / Coagucheck measurement procedure. Metric INR Test Range based on Medical Decision Points Median Bias Allowable Difference (90 % of biases) ± 0.3 ± to 4.5 ± 0.3 ± 30% 4.6 to 6.0 ± 0.7 ± 30%*

11 2 capillary sample (fingerstick) to be taken: Capillary sample tested on a Xprecia Stride PT/INR analyzer Capillary sample tested on Coaguchek XS Venous samples to be taken: Venous Tube: 3.2% (0.109 M) sodium citrate to be centrifuged and resulting plasma tested on laboratory instrument.

12 Linear regression and Coefficient of Determination - calculated between PT/INR from Xprecia Stride PT/INR analyzer and Coaguchek. Correlation and bias - graphically evaluated.

13 To meet the minimum requirements of verification of system accuracy, a minimum of 80 warfarin subjects and 20 subjects not receiving anticoagulation therapy will be enrolled. INR Values # Subjects Per Site < (Normals not on warfarin) Maximum Minimum to 4.5 Minimum to 6.0 Minimum to 8.0 Minimum 3 Total Minimum 110

14

15 Including Outlier Data Excluding Outlier Data Item Result Lower Upper Lower Upper Result 95%CI 95%CI 95%CI 95%CI All Sites N Min INR Max INR Intercept Slope R r Sy.x Bias at Bias at

16 Statistic Median bias %within ±0.5 INR %within ±30% %within ±40% INR Normals 0.0 (Spec = +0.3) (Spec = >90%) INR Warfarin Subjects up to NA 99.3 INR 2.0 to (Spec = +0.3) INR 4.6 to (Spec = +0.7) NA NA NA 99.1 (Spec >90%) NA INR Warfarin Subjects up to 8.0 INR 2.0 to (Spec = >97%) Statistic Median bias %within ±0.5 INR %within ±30% %within ±40% INR Normals 0.0 (Spec = +0.3) (Spec = >90%) Warfarin Subjects up to NA INR 2.0 to (Spec = +0.3) INR 4.6 to (Spec = +0.7) NA NA NA (Spec >90%) NA INR Warfarin Subjects up to (Spec = >97%) INR 2.0 to (Spec = >97%) All Data Excluding Outliers

17

18 Including Outlier Data Excluding Outlier Data Item Result Lower Upper Lower Upper Result 95%CI 95%CI 95%CI 95%CI All Sites N Min INR Max INR Intercept Slope R r Sy.x Bias at Bias at Item Including Outlier Data Lower Upper Result 95%CI 95%CI All Sites Excluding Outlier Data Lower Result 95%CI Upper 95%CI N Min INR Max INR Intercept Slope R r Sy.x Bias at Bias at Stride VS ACL TOP Stride VS Roche Coaguchek XS

19 Xprecia Stride Xprecia Stride exp LQC exp 2-8- LQC n (5 runs/6 reps per run) 30 n (5 runs/6 reps per run) 30 SD 0.03 SD 0.04 Mean 1.19 Mean 1.18 Target 1.20 Target 1.20 RMSD 0.04 RMSD 0.05 %RMSD 3.04 %RMSD 4.03 CV% 2.91 CV% exp LQC exp LQC 2 3/22 22/ /22/2016 n (5 runs/6 reps per run) 30 n (5 runs/6 reps per run) 30 SD 0.06 SD 0.09 Mean 2.99 Mean 2.99 Target 3.00 Target 3.00 RMSD 0.06 RMSD 0.09 %RMSD 2.02 %RMSD 2.98 CV% 2.03 CV% 3.01

20 Stride SN LQC 1 Precision over 5 days Stride SN LQC 2 Precision over 5 day

21 Ease of use Barcode reader Data export Staff ID

22 Sensitive touch screen On board tutorials Low blood volume (6uL)

23 On board storage QC and Patient data 300 QC 640 Patient INR USB output to management software Test strip ejection

24 No EQA scheme Pilot scheme with NEQAS Connectivity not yet fully functional Runs on AA batteries

25 Extended Validation Clinical impact Implementation across service?

26 Steve Carey, Product Manager, PoCT. Siemens PLC Jonathan Thompson, Specialist Biomedical Scientist, Leeds Anticoagulant Service Chris Hughes, Chief Biomedical Scientist, Specialist Haemostasis, LTH LTH Phlebotomy Team

27 Any Questions?