Clinical Chemistry Analysers: A Buying Guide for Facility Managers

Executive buying summary

Clinical chemistry analysers automate the measurement of various substances in biological fluids, providing crucial diagnostic information for patient care. Selecting the right analyser involves balancing throughput requirements with available space and budget, while ensuring compatibility with existing laboratory workflows. Total cost of ownership is influenced by consumables usage, maintenance frequency, and the need for skilled personnel. A significant risk is selecting a system that doesn't meet current or anticipated testing demands, leading to bottlenecks and potential diagnostic delays.

• Careful consideration of throughput and sample volume is essential for selecting an appropriate analyser type.
• Adherence to relevant standards, including ISO 15189 and UK MDR 2002, is paramount for ensuring accurate and reliable results.
• Data integrity and compliance with GLP and GMP requirements are crucial for maintaining audit trails and traceability.
• Thorough validation and ongoing performance monitoring are necessary to guarantee the analyser’s continued accuracy and reliability.
• A comprehensive service and maintenance plan is vital for minimising downtime and extending the analyser's lifespan.

Equipment types compared

Key features to look for

• Sample Handling System: The system should reliably process a range of sample types and volumes, and the supplier should detail its capacity and error handling capabilities.
• Reagent Management: Automated reagent loading, tracking, and expiry date monitoring are vital for reducing manual intervention and minimising waste.
• Quality Control Capabilities: Built-in quality control checks and statistical analysis are essential for ensuring result accuracy and reliability.
• Data Management and Connectivity: The analyser should seamlessly integrate with the laboratory information system (LIS) to ensure efficient data transfer and traceability.
• Calibration and Maintenance Requirements: Understand the frequency and complexity of calibration and maintenance procedures, and the associated resource requirements.
• Throughput and Assay Menu: Confirm the analyser’s throughput meets current and projected needs, and that it supports the required assays.
• User Interface and Ergonomics: A user-friendly interface minimises training time and reduces the risk of operator error.
• Safety Features: Ensure appropriate safety features are in place, including containment measures for hazardous reagents and compliance with PUWER regulations.

Pros and cons of each equipment type

Discrete Analyser

Pros: Relatively compact footprint, suitable for smaller laboratories, lower initial investment.

Cons: Lower throughput compared to continuous flow systems, potentially higher per-test reagent cost.

Continuous Flow Analyser

Pros: High throughput, suitable for high-volume testing, often modular for future expansion.

Cons: Larger footprint, higher initial investment, more complex maintenance.

Dry Chemistry Analyser

Pros: Very compact, suitable for point-of-care testing, minimal hands-on time.

Cons: Limited assay menu, lower throughput, potential for reagent instability.

Immunoassay Analyser (Chemiluminescence)

Pros: High sensitivity for detecting low-concentration analytes, wide range of assays available.

Cons: Higher reagent costs, potential for interference from certain substances.

Nephelometry/Turbidimetry Analyser

Pros: Relatively simple technology, suitable for measuring protein and other particulate substances.

Cons: Lower sensitivity compared to other techniques, potential for interference from turbidity.

Which facilities each type suits

• Discrete Analyser: Smaller hospital laboratories, outpatient clinics, general practitioner surgeries.
• Continuous Flow Analyser: Large hospital laboratories, reference laboratories, high-volume testing facilities.
• Dry Chemistry Analyser: Point-of-care testing locations, emergency departments, intensive care units.
• Immunoassay Analyser (Chemiluminescence: Hospital laboratories with a high demand for immunoassays, research laboratories.
• Nephelometry/Turbidimetry Analyser: Clinical laboratories performing protein and immunology assays, veterinary laboratories.

Buyer's checklist

1. Site Assessment: Verify adequate space, power supply, ventilation, and drainage are available.
2. Regulatory Compliance: Confirm compliance with UK MDR 2002 and relevant IVD regulations.
3. Sample Volume and Throughput Requirements: Accurately assess current and projected testing volumes.
4. LIS Integration: Ensure seamless integration with the existing laboratory information system.
5. Validation Plan: Develop a comprehensive validation plan to demonstrate analyser performance.
6. Operator Training: Arrange for thorough training of laboratory personnel on analyser operation and maintenance.
7. Service and Maintenance Contract: Secure a comprehensive service and maintenance contract with guaranteed response times.
8. Spare Parts Availability: Confirm the availability of spare parts and consumables.
9. Data Integrity Plan: Implement a robust data integrity plan to comply with GLP and GMP requirements.
10. Lifecycle Planning: Consider the analyser’s expected lifespan and plan for eventual replacement or upgrade.