4 - POINT-OF-CARE TESTING Flashcards

1
Q
  • Combines medicine and technolog
  • Involves engineering streams of Electrical, Chemical, Mechanical, and Materials
  • Invent, design, and build new types of diagnostics, monitoring tools, and therapies
  • 3D-printed body parts, cardiac pacemakers, 4D ultrasounds, x-ray machines, brain-machine interfaces and robotic prosthetics
A

Biomedical Engineering

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2
Q

Analytical patient-testing performed outside the clinical laboratory

A

Point-of-Care Testing

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3
Q

Other names for POCT

A
  • Near-patient testing
  • Extra-laboratory analyses
  • Ancillary testing
  • Bedside testing
  • Physician’s office testing
  • Alternative site testing
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4
Q

POCT Checklist

A
  1. Quality management
  2. Specimen handling
  3. Reagents
  4. Instruments and equipment
  5. Personnel
  6. Quality control and calibration
  7. Safety
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5
Q
  • POCT providing equivalent results with those from the central laboratory
  • Still, accuracy and imprecision concerns were observed in some POCT
A

Quality Management

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6
Q

Quality Assurance

A
  1. Internal Quality Control
  2. External Quality Control
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7
Q
  • Onboard QC, internal checks, electronic QC, intelligent QC
  • Performed in a specific time, interval or daily
A

Internal Quality Control

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8
Q
  • Proficiency testing
  • “Blind samples” for participating labs
A

External Quality Control

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9
Q
  1. A mechanism to perform a thorough systems validation
  2. Reliable, user-friendly device
  3. Training of operators
  4. Competency assessment of all individuals involved in POCT
  5. QC testing and monitoring
  6. Ensuring required maintenance
  7. Proficiency testing
  8. Connectivity and bar-coding technologies
A

Total System POCT Quality Assurance

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10
Q

Advantages of POCT

A
  1. Major: faster delivery of results
  2. Work with flow of patient management and care
  3. Faster medical decision
  4. Smaller sample volume requirement
  5. Requires smaller amount of reagent
  6. Requires few steps
  7. Portability of the device
  8. Aids in the reduction of pre-analytical and post-analytical lab related errors
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11
Q

Disadvantages of POCT

A
  • Quality of results is a concern
  • POCT performed by non laboratory personnel (nurses, physicians, emergency medical technicians, paramedics, pharmacists, medical office assistant, even patients)
  • Training: “Value of Laboratory Quality Control)
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12
Q

Phases of Microbiology Testing

A
  1. Preanalytical Phase
  2. Analytical Phase
  3. Post-analytical Phase
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13
Q
  • Patient assessment and test ordering
  • Specimen collection
  • Specimen transport
A

Preanalytical Phase

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14
Q
  • Specimen evaluation
  • Specimen processing
  • Validation results
A

Analytical Phase

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15
Q
  • Reporting
  • Interpretation
  • Diagnosis and treatment
A

Post Analytical Phase

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16
Q

POCT Analyzers Desirable Characteristics

A
  1. Ease of use
  2. Method accuracy
  3. Comparable to central lab
  4. Portability
  5. Durability
  6. Low maintenance
  7. Simple QC
  8. Simple sample handling
  9. Barcode patient ID
  10. Lab Information System (LIS) ready
  11. Electronic Medical Record (EMR)
17
Q

Analytical Principles

A
  1. Reflectance
  2. Electrochemistry/Electrical Impedance
  3. Light scattering/Optical motion
  4. Immunoturbidimetry
  5. Lateral flow
  6. Spectrophotometry
  7. Fluorescence
  8. Polymerase chain reaction
18
Q
  • Patient and operator ID
  • Reference range
  • Result documentation (permanent record)
  • Analyzers connected to LIS or DM system
  • Modem, internet, display screen, printer
A

Informatics

19
Q
  1. Patient, sample, operator, and device IDs
  2. Date and time: specimen collection and analysis
  3. Type of specimen
  4. Test requested and test result (unit)
  5. Error messages and action messages (if any)
A

Patient Information

20
Q
  1. Reference range
  2. Calibrator
  3. Reagent
  4. QC details (lot number and expiration date)
  5. Specific comments and alerts
A

Other Information

21
Q

Available POCT Tests

A
  1. Qualitative
  2. Quantitative
22
Q

examples of POCT tests

A
  1. hCG
  2. Glucose
  3. Hemoglobin (Hb)
  4. Rapid HIV
  5. Cardiac markers – troponin
  6. pH and urinalysis
  7. HbA1c
  8. Blood gasses (pH, O2, PCO2, HCO3)
  9. Electrolytes