CC LEC M3 U6

• Point-of-care testing (POCT) is a method of clinical laboratory testing where analysis is done close to where healthcare is provided to the patient
• POCT can be employed in various environments including primary care settings like home, community pharmacies, health centers, retail clinics, workplace clinics, physician’s offices, and diagnostic and treatment centers
• In secondary care, POCT can be used in settings like emergency rooms, admissions units, ambulatory diagnostic and treatment centers, operating rooms, intensive care units, wards, and outpatient clinics
• POCT devices are used for clinical applications in physician offices, emergency departments, intensive care units, and even for self-testing, offering reduced turnaround time for results
• POCT relies on the same analytic techniques as laboratory-based instrumentation: spectrometry, electroanalytic techniques, and chromatography
• Advantages of POCT include convenience for healthcare providers and patients, reduced turnaround time for test results, better patient management, decreased manpower needs, and improved patient outcomes
• Advantages also include a wide menu of POC analytes for specimens that do not require processing and availability to a wider variety of sites
• Disadvantages of POCT include higher costs compared to central laboratory testing, difficulties in quality control and assurance, challenges in managing multiple sites and operators, and difficulties with documentation and regulatory compliance
• POCT is classified by the FDA as waived tests, moderate-complexity tests, or high-complexity tests based on criteria like complexity of the test and risk to the patient
• Waived tests are subject to the lowest level of regulation, are cleared for home use, and require no special training or educational background for operation
• Moderate-complexity tests are more difficult to perform than waived tests and usually employ hand-held automated methodology
• Provider-performed microscopy procedures (PPMPs) are a subcategory of moderate-complexity tests that involve the use of a microscope for slide examinations of freshly collected body fluids
• Point-of-care testing (POCT) analyzers characteristics and requirements:

  • Reduced errors and enhanced patient care
  • Results produced rapidly (typically within a minute)
  • Portable instruments with consumable reagent cartridges
  • Capability of performing direct specimen analysis on whole blood and urine
  • Simple operating procedures
  • Flexible test menus
  • Quantitative results with accuracy and precision comparable with central laboratory
  • Built-in/integrated calibration and quality control
  • Ambient storage temperature for reagents
  • Results provided as hard copy and can be stored and transmitted
  • Low instrument cost
  • Built-in regulatory record keeping
• Classifications of types of POCT devices:

  1. Single-use, qualitative or semiquantitative cartridge/strip tests for analytes like urine and blood chemistry, infectious disease agents, cardiac markers, and hCG

  2. Single-use, quantitative cartridge/strip tests with a reader device for analytes like glucose, blood chemistry, coagulation, cardiac markers, drugs, and more

  3. Multiple-use, quantitative cartridge/benchtop devices for analytes like hemoglobin species, bilirubin, blood gases, electrolytes, and more
• Applications of POCT:

  • Point-of-Care Glucose: used to monitor glucose levels, especially in diabetic patients
  • Point-of-Care Chemistries and Blood Gases: measure potentiometric, amperometric, or conductometric changes via sensors
  • Point-of-Care Coagulation: common test is activated clotting time (ACT) for monitoring heparin therapy
  • Point-of-Care Hematology: tests include spun hematocrit and systems with disposable cuvettes and an analyzer
  • Point-of-Care Connectivity: allows electronic documentation of testing results
• Variables that can alter Point-of-Care Testing Blood Glucose Results:

  • Preanalytical factors like blood type, instrument cleaning, and quality control procedures
  • Analytical factors such as glucose and hematocrit extremes, improper technique, and calibration mismatches
  • Postanalytical factors like data entry errors