Number of POCT Tests William Clarke, PhD, MBA, DABCC Department of - - PowerPoint PPT Presentation

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Number of POCT Tests William Clarke, PhD, MBA, DABCC Department of - - PowerPoint PPT Presentation

Sep 17, 2023 225 likes •734 views

Perspectives on the Rapidly Growing Number of POCT Tests William Clarke, PhD, MBA, DABCC Department of Pathology Johns Hopkins University School of Medicine Disclosures Grant/Research Support: Thermo Fisher, Shimadzu, Nova Biomedical,

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Perspectives on the Rapidly Growing Number of POCT Tests

William Clarke, PhD, MBA, DABCC Department of Pathology Johns Hopkins University School of Medicine

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Disclosures

  • Grant/Research Support: Thermo Fisher, Shimadzu,

Nova Biomedical, Instrumentation Laboratories, miDiagnostics, NIH

  • Consultant/Advisory Board: Thermo Fisher,

Shimadzu, Nova Biomedical, Roche Diagnostics, Instrumentation Laboratories, Radiometer, BD Diagnostics, Hitachi High-Technologies

  • Equity: miDiagnostics
  • Honorarium/Expenses: J&J
  • Intellectual Property/Royalty Income: None
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Objectives

  • Describe the current POCT landscape –

including existing technologies and emerging needs

  • Discuss challenges associated with the rapidly

growing number of available POCT applications

  • Formulate strategies for efficiently managing a

growing POCT program

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In Vitro Diagnostics Market in $B

POCT is strongest growing segment

Point of Test 2013 2014 2015 2020 CAGR (2015- 2020) Laboratory 12.2 12.9 13.7 17.4 4.9% Hospitals 23.2 24.7 26.3 34.9 5.8% Academic Institutes 1.9 2.0 2.1 2.6 4.1% Point-of-Care 5.4 5.9 6.5 9.7 8.5% Patient Self-Testing (Point-of-Need) 4.6 4.9 5.2 6.9 5.7% Others (include blood banks, local public health laboratories, community clinics labs, home health agencies, nursing homes, etc) 2.6 2.7 2.9 3.6 4.6% Total 49.9 53.1 56.7 75.1 5.8%

(Markets tsandMarkets, 20 2015)

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Trends & Challenges

  • Care shifts from in- to outpatients
  • Patients and consumers are more health conscious
  • Emerging economies aim to improve health care
  • Increasing cost pressure within the health care systems
  • Empowerment and Access
  • Context disruptions for health care professionals
  • Delayed or false treatment
  • Infrastructure gaps
  • Inefficiencies and negative impacts on patient outcome
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Accountable Care Organizations

http://modernpractices.com/2013/06/20/accountable-care-organizations-impact-on-behavioral-health-providers/

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Home Health Testing

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Disease Incidence & Prevalence (US)

55 46 31 30 17 11 4 4 9 23 27

6

15 20 350 10 5 50 40 30 20 10 350 25

CVD** Resp. Musc/Skele. Onc Immuno. Neuro Pre- Natal GI Hemato.

Incidence (MM)

Uro.

Prevalence (MM)

Chronic ID* Pain Acute ID*

349

Prevalence Incidence (MM)

Acute Chronic

*Acute ID= bacterial + fungal infections; Chronic ID = HIV, Herpes, HCV, HBV ** = both acute and chronic indications included

  • Sources. Cowen Report March 2010, NIH, CDC, NHLI, Wrongdiagnosis.com, emedicine.com, CMS CPT codes, NIAID, NCI
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AdvaMedDx: Essentials of Diagnostics – Molecular Diagnostics (2013)

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AdvaMedDx: Essentials of Diagnostics – Molecular Diagnostics (2013)

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www.advameddx.org (innovation & value)

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www.advameddx.org (innovation & value)

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http://ho.seas.ucla.edu/group-members/postdoctoral-researchers/peter-lillehoj

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http://dental.nyu.edu/faculty/biomaterials/mcdevitt-research-group.html

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www.nanoporetech.com/technology/

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NEAR-TERM EMERGING TECHNOLOGIES

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CONSIDERATIONS FOR NEW TECHNOLOGIES

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Accuracy of Laboratory Measurements

  • Accuracy = closeness of measurement to

“truth”

– Often standard reference is a substitute for “truth”

  • Inaccuracy is a function of 2 things:

– Bias – Imprecision

  • There is no perfect analytical method
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Perception vs. Reality

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Pre-Analytical Factors

  • Poor technique in washing hands

– Residual disinfectant – External contamination (e.g. juice)

  • Inappropriate sampling

– Poor perfusion – Peripherial Vascular Disease – Shock/dehydration

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How to address inaccuracy?

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How to address inaccuracy?

  • Assumption of parameters/relationships
  • Active correction
  • Correction through device offsets
  • Standardization of Devices
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Capillary Sampling

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60 80 100 120 140 160 180 0 Hr 0.5 Hr 1 Hr 2 Hr 3 Hr

Venous Capillary

Davidson JK, Parker DR. Monitoring of blood and urine glucose and ketone levels. In Davidson JK, ed. Clinical Diabetes Mellitus Regittnig W, et al. Am J Physiol Endocrinol Metab 2003 (285) E241. Jungheim K, Koschinsky T. Diabetes Care 2001 (24) 1303.

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Clinical Utility

  • POCT is not a “black box” fix; nor is it

something to do just because it’s available

  • Does the POCT request fix the problem?

– Will the test allow rule-in or rule-out diagnosis? – Why does the central or critical care/satellite lab not meet the need? – Can therapy or consultation be initiated based on POCT result?

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Clinical Utility

  • Faster results does not guarantee improved

clinical outcome

  • To assess clinical utility, need to evaluate:

– Reason for ordering test – How the result will be utilized for patient care – Is POCT method appropriate for patient needs in that particular setting?

  • Communication with clinical staff is vital for

determination of clinical utility and implementation

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www.advameddx.org (innovation & value)

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www.advameddx.org (innovation & value)

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MANAGING AN INCREASING VARIETY OF TESTS

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Joint Ownership of Program

  • Important for each of the clinical testing sites to

have active involvement in program management

– Self-education and inspection (QA) – Take responsibility for ongoing training and education

  • Schedule periodic joint leadership meetings

– Allow communication of important points to users – Allow input from users for improved program efficiency

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POCT Management at JHMI

Nursing Standards of Care Committee Medical Director: William Clarke Manager: Jeanne Mumford QA Specialist: Lois Berk POCT Coordinator: Sope Willoughby POCT Coordinator: Leandra Soto POCT Coordinator: Kitty Selitto (HCGH) POCT Coordinator: Karen Reilly POCT Committee POCT Coordinator: Gwendetta Norwood (Sibley) POCT Coordinator: Ryan Work (Suburban) POCT Coordinator: Serafina Brea (Bayview)

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Connected POC Network

LAN

Central Data Manager

Hospital or Department Patient Database

POC Devices

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WHAT DO DATA-DRIVEN DECISIONS LOOK LIKE?

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FDA Surveillance Grid

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Hospital-Wide Analysis

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Adult and Pediatric Emergency Dept

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All JHH ICU’s

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JHH MICU

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Closing Thoughts

  • POCT has the potential to dramatically impact the

delivery of healthcare – particularly outside of the hospital

  • Emerging technologies may significant increase

the variety of testing platforms requested for POCT

  • With new technologies, there are many

considerations for successful implementation

  • With increasing POCT, a thoughtful and efficient

plan for management is crucial to a successful POCT program

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QUESTIONS??

wclarke@jhmi.edu