Point-of-Care Testing

Current Issues and Evidence

Kathleen Kulyk & Krista Kaminski May 5, 2019

Outline

• Who is CADTH?

• What is Point-of-Care Testing (POCT)?

• Issues related to implementation and management

• Categories and examples

• Using health technology evidence

• Question and Discussion

Disclosure

• CADTH is funded by federal, provincial, and territorial ministries of health.

• Application fees for three programs:

• CADTH Common Drug Review (CDR)

• CADTH pan-Canadian Oncology Drug Review (pCODR)

• CADTH Scientific Advice

Disclosure – CADTH

• Relationship with Commercial Interest: None

• Grant/Research Support: None

• Speaker Bureau/Honoraria: None

• Consulting fees: None

• Memberships on advisory committees, boards: None

Other Affiliations:

I am a CADTH employee independently based in Saskatchewan

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Point-of-Care Testing (POCT)

Source: labtestsonline.org

What is POCT?

• Diagnostic tests performed at or near patient’s location

• Testing done by health care professional, other qualified

personnel, or patient

• Setting

• Hospital

• Pharmacy

• Ambulance

• Patient’s residence

• Long-term care facility

Advantages

• Increased staff and patient mobility

• Portability across community and rural settings

• Rapid turnaround time for test results

• Expedited decision-making and patient engagement

• Increased efficiency of care

Why should you care?

Source: Eternity

CADTH’s Research to Date: POCT

How is POCT implemented and managed across Canada?

Key Messages – Who, Where, Why?

• Who?

• Primarily nurses

• Where?

• Emergency and urgent care

• Hospital in-patient care

• Why?

• Reduce turnaround time, increase patient convenience,

provide access to testing in remote or rural areas

Key Messages – Training and

Certification

• Much variation across institutions

• Provincial accreditation standards designate training to

responsibility of individual laboratories

• Design and implementation of own training programs

• Canada does not have national standards and guidelines

for laboratory accreditation and POCT

• Most provinces have their own laboratory accreditation

standards

Key Messages – Barriers to

Implementation

• Institution’s organizational structures

• Authority and accountability

• Departmental buy-in

• Financial support

Key Messages – Challenges

• Quality assurance

• Order and results documentation

• Operator proficiency

• Rapid technology development

Source: Z Values

Key Messages – What’s Ahead?

• Jurisdictional interest in expanding and improving support

for POCT in Canada

• Uncertainty remains about the status of these

technologies

3 Categories of POCT

• Drug therapy and patient self-monitoring

• Diagnostics - lab-based

• Diagnostics – medical imaging

Source: www.alere.com

Drug Therapy and Patient Self

Monitoring - Examples

Self-monitoring of blood glucose

• Type 1, Type 2, gestational diabetes

• Blood sample is applied to a strip

• Glucose concentration is read by an electronic

monitor

Drug Therapy and Patient Self

Monitoring - Examples

International Normalized Ratio (INR) for patients taking

warfarin or other vitamin K antagonists

• Standard of care

• Lab testing of blood (venipuncture) to measure INR

• Test results = 1 hour (ER) to 24 hours (not including

transit time)

• POCT

• Coagulometer to measure blood sample (finger stick)

• Test results = 3 minutes

Drug Therapy and Patient Self

Monitoring - Examples

• POCT – 3 main INR testing applications

• Patient self-management: self-testing and self-adjusting

medication dose based on results using a predetermined

algorithm or protocol

• Patient self-testing: clinician adjusting medication dose

based on results

• Clinic-based – POC testing is performed in a clinical

setting (i.e. physician’s office, anticoagulation clinic)

Drug Therapy and Patient Self

Monitoring - Examples

• CADTH’s Key Findings

• POC INR testing is an accurate alternative to lab INR

testing.

• Patient self-management is the most cost-effective.

• Patient self-testing with health care provider dose

adjustment may be an option when lab INR testing is

difficult.

• Clinic-based POC INR testing requires careful

consideration of context and costs.

• Patients prefer finger stick by POC metres compared

with venous collection.

Diagnostics – Lab Based

Point of Care Testing for Infectious Diseases: Hepatitis C,

HIV

• Standard of Care

• Lab-based testing

• POCT

• Over-the-counter testing for patients self-testing or

pharmacists testing

• Rapid antibody test for Hep C and HIV

Diagnostics – Lab Based

CADTH’s Key Findings

• POC tests provide a reliable diagnostic strategy for Hep C

• Performance may vary among different POC tests

• Costs per test, per person were similar between POC tests

and lab-based assays

• For patient self-testing or pharmacist testing for HIV,

hepatitis C, there was no evidence found on clinical

effectiveness, or evidence-based guidelines compared with

conventional testing in a lab.

Diagnostics – Lab Based

Point of Care Testing for Infectious Diseases: Group A

Streptococcal Infection

• Standard of Care

• Throat culture

• POCT

• Rapid, non-culture based methods based on

immunoassays and molecular assays

Diagnostics – Lab Based

CADTH’s Key Findings

• No clear advantage of rapid antigen testing over a clinical

score with respect to duration, severity or antibiotic use

• No adverse outcomes noted

• POC does not provide antimicrobial susceptibility testing

• Intuitiveness a factor in quality of results

Diagnostics – Lab Based

Point of Care Testing for Infectious Diseases: Influenza

• Standard of Care

• RT-PCR lab test requiring viral culture = 1-14 days

• POCT

• Viral antigen detection with antibodies = >30 mins

• Not as sensitive as RT-PCR lab test

• RT-PCR bench top device and assay tube,

nasopharyngeal swab = 20 mins

Diagnostics – Lab Based

CADTH’s Key Findings

• POCT RT-PCR

• May provide greater diagnostic performance than

existing viral antigen tests

• May be as effective as lab based methods

• Viral antigen tests

• May reduce health care costs and improve patient care

through more appropriate use of antibiotic and antiviral

medications

• May improve access to testing outside of lab settings

Diagnostics – Medical Imaging

Portable Ultrasound Devices Use by Non-Radiologists

• Standard of Care

• Magnetic resonance imaging or fixed ultrasound

• POCT

• Portable ultrasound devices

• Patient population

• Musculoskeletal conditions (i.e. rotator cuff, ligament

injury, other soft tissue injuries)

Diagnostics – Medical Imaging

Portable Ultrasound Devices Use by Non-Radiologists

• CADTH’s Key Findings

• Non-physicians operating portable ultrasound after

receiving short training = 81% diagnostic quality

• Non-physicians operating under guidance of a specialist

via satellite = 86.2% diagnostic quality

• No significant difference between groups

• Portable ultrasound devices were clinically effective and

accurate for the assessment and management of

patients with musculoskeletal conditions.

Questions?

SKSupport@cadth.ca