Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds Anticoagulant Service
� Leeds Teaching Hospitals � Currently undergoing a Service Development Project � Initiated PoCT in Clinics in 2012
� Roche Coaguchek � Pathology Managed Service Contract � Siemens Xprecia Stride
� Over 10,000 patients � Stable patients � Community Health Centres
� Operate a “Dose and Post” service using venous blood samples
� Moving towards a more patient- facing service using capillary sampling
� Why use the Stride? � Managed Service � Ease of Use � Cost
� Purpose and Scope Purpose and Scope Purpose and Scope 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
� 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).
� Acceptance Criteria Over the Measuring Range: Slope: 95% confidence interval within 0.80 – 1.20 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 Allowable Difference Median Bias Medical Decision (90 % of biases) Points 0.8 - 1.9 ± 0.3 ± 0.5 2.0 to 4.5 ± 0.3 ± 30% 4.6 to 6.0 ± 0.7 ± 30%*
� 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.
� Linear regression and Coefficient of Determination - calculated between PT/INR from Xprecia Stride PT/INR analyzer and Coaguchek. � Correlation and bias - graphically evaluated.
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 <0.8-1.2 (Normals not on warfarin) Maximum 19 1.0-1.9 Minimum 11 2.0 to 4.5 Minimum 72 4.6 to 6.0 Minimum 6 6.1 to 8.0 Minimum 3 Total Minimum 110
Including Outlier Data Including Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Lower Upper Lower Upper Item Item Item Item Result Result 95%CI 95%CI 95%CI 95%CI All Sites All Sites All Sites All Sites N N N N 173 171 Min INR Min INR Min INR Min INR 0.9 0.9 Max INR Max INR Max INR Max INR 5.6 5.6 Intercept Intercept Intercept Intercept -0.02 -0.10 0.07 0.01 -0.10 0.08 Slope Slope Slope Slope 0.97 0.91 1.00 0.95 0.90 1.00 R R R R 0.943 0.961 r r 2 r r 2 0.889 0.924 2 2 Sy.x Sy.x Sy.x Sy.x 0.35 0.26 Bias at 2.0 Bias at 2.0 Bias at 2.0 Bias at 2.0 -0.08 -0.08 Bias at 4.5 Bias at 4.5 Bias at 4.5 Bias at 4.5 -0.16 -0.20
Warfarin Warfarin Warfarin Warfarin INR INR INR INR INR INR INR INR INR INR INR INR Subjects up Subjects up Subjects up Subjects up Warfarin Warfarin Warfarin Warfarin Warfarin Warfarin Warfarin Warfarin INR 2.0 to INR 2.0 to INR 4.6 to INR 4.6 to INR 2.0 to INR 2.0 to Warfarin Warfarin Warfarin Warfarin INR 2.0 to INR 2.0 to INR 4.6 to INR 4.6 to INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to INR 4.6 to INR 4.6 to INR 4.6 to INR 4.6 to INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to Statistic Statistic Statistic Statistic INR Normals INR Normals INR Normals INR Normals to 4.5 to 4.5 to 4.5 to 4.5 Subjects Subjects Subjects Subjects Statistic Statistic Statistic Statistic INR Normals INR Normals INR Normals INR Normals Subjects up Subjects up Subjects up Subjects up Subjects Subjects Subjects Subjects 4.5 4.5 4.5 4.5 6.0 6.0 6.0 6.0 8.0 8.0 8.0 8.0 4.5 4.5 4.5 4.5 6.0 6.0 6.0 6.0 8.0 8.0 8.0 8.0 up to up to up to up to to 4.5 to 4.5 up to up to up to up to to 4.5 to 4.5 8.0 8.0 8.0 8.0 8.0 8.0 8.0 8.0 0.0 (Spec = -0.2 (Spec = 0.5 (Spec 0.0 (Spec = -0.2 (Spec = 0.8 (Spec Median bias Median bias Median bias Median bias -0.1 Median bias Median bias -0.1 +0.3) +0.3) = +0.7) Median bias Median bias +0.3) +0.3) = +0.7) %within %within %within %within 100.0 (Spec %within %within %within %within 100.0 (Spec NA NA NA NA NA NA ±0.5 INR ± ± ± 0.5 INR 0.5 INR 0.5 INR = >90%) ±0.5 INR ± 0.5 INR = >90%) ± ± 0.5 INR 0.5 INR %within %within 100.0 (Spec %within %within %within %within %within %within 99.1 (Spec NA 100.0 NA NA 99.3 NA ±30% ± ± ± 30% 30% 30% >90%) ±30% ± ± ± 30% 30% 30% >90%) 100.0 100.0 98.2 %within %within 98.7 %within %within %within %within %within %within (Spec = (Spec = (Spec = ± ±40% ± ± 40% 40% 40% ±40% ± ± ± 40% 40% 40% >97%) >97%) >97%) All Data Excluding Outliers
Including Outlier Data Including Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Lower Upper Lower Upper Lower Upper Lower Upper Item Item Result Result Item Item Item Item Item Item Result Result 95%CI 95%CI 95%CI 95%CI 95%CI 95%CI 95%CI 95%CI All Sites All Sites All Sites All Sites All Sites All Sites All Sites All Sites N N 173 171 N N N N N N 168 167 Min INR Min INR Min INR Min INR 0.9 0.9 Min INR Min INR Min INR Min INR 0.9 0.9 Max INR Max INR 5.6 5.6 Max INR Max INR Max INR Max INR 5.4 5.4 Max INR Max INR Intercept Intercept Intercept Intercept -0.02 -0.10 0.07 0.01 -0.10 0.08 Intercept Intercept Intercept Intercept 0.03 -0.06 0.12 0.05 -0.03 0.12 Slope Slope Slope Slope 0.97 0.91 1.00 0.95 0.90 1.00 Slope Slope 0.90 0.87 0.94 0.89 0.86 0.93 Slope Slope R R R R 0.943 0.961 R R R R 0.957 0.972 r 2 r r r 0.889 0.924 2 2 2 r 2 r 0.916 0.945 r r 2 2 2 Sy.x Sy.x Sy.x Sy.x 0.35 0.26 Sy.x Sy.x Sy.x Sy.x 0.31 0.23 Bias at 2.0 Bias at 2.0 Bias at 2.0 Bias at 2.0 -0.08 -0.08 Bias at 2.0 Bias at 2.0 -0.17 -0.17 Bias at 2.0 Bias at 2.0 Bias at 4.5 Bias at 4.5 Bias at 4.5 Bias at 4.5 -0.16 -0.20 Bias at 4.5 Bias at 4.5 Bias at 4.5 Bias at 4.5 -0.42 -0.44 Stride VS Roche Stride VS ACL TOP Coaguchek XS
Xprecia Xprecia Stride Xprecia Xprecia Stride 100727 Stride Stride 100727 100727 100727 Xprecia Xprecia Xprecia Xprecia Stride Stride 101128 Stride Stride 101128 101128 101128 509009 509009 exp exp 2 2- -8 8- -2016 2016 LQC 1 509009 exp 2-8- LQC 1 509009 509009 exp exp 2 2 - - 8 8 - - 2016 2016 2016 n ( n n n ( ( (5 5 5 runs/ 5 runs/6 runs/ runs/ 6 6 reps 6 reps reps reps per per per per n (5 runs/6 reps per run) run) run) 30 run) run) 30 SD SD SD 0.04 SD SD 0.03 Mean Mean Mean 1.18 Mean Mean 1.19 Target Target Target 1.20 Target Target 1.20 RMSD RMSD RMSD 0.05 RMSD RMSD 0.04 % %RMSD RMSD %RMSD 4.03 % % RMSD RMSD 3.04 CV% CV % 2.91 CV% 3.66 CV CV % % 509109 509109 509109 509109 exp exp exp exp LQC 2 509109 exp LQC 2 3 3/ /22 22/ /2016 2016 3/22/2016 3 3 / / 22 22 / / 2016 2016 n n n n ( ( ( (5 5 runs/ 5 5 runs/ runs/ runs/6 6 6 reps 6 reps reps reps per per per per n (5 runs/6 reps per run) 30 run) run) run) run) 30 SD SD SD 0.09 SD SD 0.06 Mean Mean Mean 2.99 Mean Mean 2.99 Target Target Target 3.00 Target Target 3.00 RMSD RMSD RMSD 0.09 RMSD RMSD 0.06 % %RMSD RMSD %RMSD 2.98 % % RMSD RMSD 2.02 CV CV% % 2.03 CV% 3.01 CV CV % %
Stride SN 100727 LQC 1 Stride SN 100727 LQC 2 Precision over 5 days Precision over 5 day
� Ease of use � Barcode reader � Data export � Staff ID
� Sensitive touch screen � On board tutorials � Low blood volume (6uL)
� On board storage – QC and Patient data ◦ 300 QC ◦ 640 Patient INR � USB output to management software � Test strip ejection
� No EQA scheme ◦ Pilot scheme with NEQAS � Connectivity not yet fully functional � Runs on AA batteries
� Extended Validation � Clinical impact � Implementation across service ?
� 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
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