Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds - - PowerPoint PPT Presentation

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Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds - - PowerPoint PPT Presentation

Oct 09, 2022 344 likes •634 views

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

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SLIDE 1

Brad Dickinson MSc. MIBMS Chief Biomedical Scientist Leeds Anticoagulant Service

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SLIDE 2

Leeds Teaching

Hospitals

Currently

undergoing a Service Development Project

Initiated PoCT in

Clinics in 2012

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SLIDE 3

Roche

Coaguchek

Pathology

Managed Service Contract

Siemens Xprecia

Stride

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SLIDE 4

Over 10,000

patients

Stable patients Community

Health Centres

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SLIDE 5

Operate a

“Dose and Post” service using venous blood samples

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SLIDE 6

Moving towards

a more patient- facing service using capillary sampling

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SLIDE 7

Why use the Stride? Managed Service Ease of Use Cost

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SLIDE 8

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

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SLIDE 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).

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SLIDE 10

Acceptance Criteria

Metric INR Test Range based

  • n

Medical Decision Points Median Bias Allowable Difference (90 % of biases) 0.8 - 1.9 ± 0.3 ± 0.5 2.0 to 4.5 ± 0.3 ± 30% 4.6 to 6.0 ± 0.7 ± 30%* Over the Measuring Range: Slope: 95% confidence interval within 0.80 – 1.20 Intercept: +0.3 to -0.3 Coefficient of determination (r2) ≥ 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.

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SLIDE 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.

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SLIDE 12

Linear regression and Coefficient of

Determination - calculated between PT/INR from Xprecia Stride PT/INR analyzer and Coaguchek.

Correlation and bias - graphically evaluated.

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SLIDE 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 <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

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SLIDE 14
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SLIDE 15

Including Outlier Data Including Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Item Item Item Item Result Lower 95%CI Upper 95%CI Result Lower 95%CI Upper 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 r r2

2 2 2

0.889 0.924 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
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SLIDE 16

All Data Excluding Outliers

Statistic Statistic Statistic Statistic INR Normals INR Normals INR Normals INR Normals INR INR INR INR Warfarin Warfarin Warfarin Warfarin Subjects up Subjects up Subjects up Subjects up to 4.5 to 4.5 to 4.5 to 4.5 INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to 4.5 4.5 4.5 4.5 INR 4.6 to INR 4.6 to INR 4.6 to INR 4.6 to 6.0 6.0 6.0 6.0 INR INR INR INR Warfarin Warfarin Warfarin Warfarin Subjects Subjects Subjects Subjects up to up to up to up to 8.0 8.0 8.0 8.0 INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to 8.0 8.0 8.0 8.0 Median bias Median bias Median bias Median bias 0.0 (Spec = +0.3)

  • 0.1
  • 0.2 (Spec =

+0.3) 0.8 (Spec = +0.7) %within %within %within %within ± ± ± ±0.5 INR 0.5 INR 0.5 INR 0.5 INR 100.0 (Spec = >90%) NA NA NA %within %within %within %within ± ± ± ±30% 30% 30% 30% NA 99.3 99.1 (Spec >90%) NA %within %within %within %within ± ± ± ±40% 40% 40% 40% 98.7 98.2 (Spec = >97%) Statistic Statistic Statistic Statistic INR Normals INR Normals INR Normals INR Normals Warfarin Warfarin Warfarin Warfarin Subjects up Subjects up Subjects up Subjects up to 4.5 to 4.5 to 4.5 to 4.5 INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to 4.5 4.5 4.5 4.5 INR 4.6 to INR 4.6 to INR 4.6 to INR 4.6 to 6.0 6.0 6.0 6.0 INR INR INR INR Warfarin Warfarin Warfarin Warfarin Subjects Subjects Subjects Subjects up to up to up to up to 8.0 8.0 8.0 8.0 INR 2.0 to INR 2.0 to INR 2.0 to INR 2.0 to 8.0 8.0 8.0 8.0 Median bias Median bias Median bias Median bias 0.0 (Spec = +0.3)

  • 0.1
  • 0.2 (Spec =

+0.3) 0.5 (Spec = +0.7) %within %within %within %within ± ± ± ±0.5 INR 0.5 INR 0.5 INR 0.5 INR 100.0 (Spec = >90%) NA NA NA %within %within %within %within ± ± ± ±30% 30% 30% 30% NA 100.0 100.0 (Spec >90%) NA %within %within %within %within ± ± ± ±40% 40% 40% 40% 100.0 (Spec = >97%) 100.0 (Spec = >97%)

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SLIDE 17
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SLIDE 18

Stride VS ACL TOP Stride VS Roche Coaguchek XS

Including Outlier Data Including Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Item Item Item Item Result Lower 95%CI Upper 95%CI Result Lower 95%CI Upper 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 r r2

2 2 2

0.889 0.924 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

Including Outlier Data Including Outlier Data Including Outlier Data Including Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Excluding Outlier Data Item Item Item Item Result Lower 95%CI Upper 95%CI Result Lower 95%CI Upper 95%CI All Sites All Sites All Sites All Sites N N N N 168 167 Min INR Min INR Min INR Min INR 0.9 0.9 Max INR Max INR Max INR Max INR 5.4 5.4 Intercept Intercept Intercept Intercept 0.03

  • 0.06

0.12 0.05

  • 0.03

0.12 Slope Slope Slope Slope 0.90 0.87 0.94 0.89 0.86 0.93 R R R R 0.957 0.972 r r r r2

2 2 2

0.916 0.945 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

  • 0.17
  • 0.17

Bias at 4.5 Bias at 4.5 Bias at 4.5 Bias at 4.5

  • 0.42
  • 0.44
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SLIDE 19

Xprecia Xprecia Xprecia Xprecia Stride Stride Stride Stride 100727 100727 100727 100727 Xprecia Xprecia Xprecia Xprecia Stride Stride Stride Stride 101128 101128 101128 101128 509009 509009 509009 509009 exp exp exp exp 2 2 2 2-

  • 8

8 8 8-

  • 2016

2016 2016 2016 LQC 1 509009 exp 2-8- 2016 LQC 1 n n n n ( ( ( (5 5 5 5 runs/ runs/ runs/ runs/6 6 6 6 reps reps reps reps per per per per run) run) run) run) 30 n (5 runs/6 reps per run) 30 SD SD SD SD 0.03 SD 0.04 Mean Mean Mean Mean 1.19 Mean 1.18 Target Target Target Target 1.20 Target 1.20 RMSD RMSD RMSD RMSD 0.04 RMSD 0.05 % % % %RMSD RMSD RMSD RMSD 3.04 %RMSD 4.03 CV CV CV CV% % % % 2.91 CV% 3.66 509109 509109 509109 509109 exp exp exp exp 3 3 3 3/ / / /22 22 22 22/ / / /2016 2016 2016 2016 LQC 2 509109 exp 3/22/2016 LQC 2 n n n n ( ( ( (5 5 5 5 runs/ runs/ runs/ runs/6 6 6 6 reps reps reps reps per per per per run) run) run) run) 30 n (5 runs/6 reps per run) 30 SD SD SD SD 0.06 SD 0.09 Mean Mean Mean Mean 2.99 Mean 2.99 Target Target Target Target 3.00 Target 3.00 RMSD RMSD RMSD RMSD 0.06 RMSD 0.09 % % % %RMSD RMSD RMSD RMSD 2.02 %RMSD 2.98 CV CV CV CV% % % % 2.03 CV% 3.01

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Stride SN 100727 LQC 1 Precision over 5 days Stride SN 100727 LQC 2 Precision over 5 day

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SLIDE 21

Ease of use Barcode reader Data export Staff ID

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Sensitive touch

screen

On board tutorials Low blood volume

(6uL)

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On board storage –

QC and Patient data

  • 300 QC
  • 640 Patient INR

USB output to

management software

Test strip ejection

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SLIDE 24

No EQA scheme

  • Pilot scheme with

NEQAS

Connectivity not yet

fully functional

Runs on AA

batteries

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Extended Validation Clinical impact Implementation

across service ?

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SLIDE 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

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SLIDE 27

Any Questions?