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A multi-centre evaluation of the FP-900 analyzing system.
Journal of Clinical Chemistry and Clinical Biochemistry. Zeitschrift Fur Klinische Chemie Und Klinische Biochemie
|November 1, 1983
Summary
The FP-900 Analyzing system demonstrated acceptable performance for clinical laboratory testing, meeting manufacturer specifications in a multi-centre evaluation. This study assessed its precision, accuracy, and efficiency against established standards and other analytical systems.
Area of Science:
- Clinical chemistry and laboratory diagnostics
- Analytical instrumentation and performance evaluation
Background:
- The FP-900 Analyzing system by Labsystems Oy is a microprocessor-controlled instrument for simultaneous absorbance measurements.
- Evaluation followed the European Committee for Clinical Laboratory Standards (ECCLS) draft standard for instrument testing.
Purpose of the Study:
- To evaluate the performance of the FP-900 Analyzing system in a multi-centre study.
- To compare its performance, cost, speed, and capacity with other analytical systems.
Main Methods:
- Performance testing based on ECCLS draft standard principles.
- Methodologies included cholesterol (end-point), creatinine (fixed-time kinetic), and aspartate aminotransferase (multi-point kinetic).
- Assessed within- and between-laboratory imprecision, deviation from control sera values, and carry-over.
Main Results:
- The FP-900 Analyzing system met manufacturer specifications in key performance areas.
- Imprecision and deviation from assigned values were determined for various methodologies.
- Comparative analysis with Autoanalyzer Mark I and Hitachi 705 was conducted.
Conclusions:
- The FP-900 Analyzing system is a viable option for clinical laboratory analysis.
- The study provides insights into applying the ECCLS draft standard for instrument evaluation.
- Cost, speed, and capacity were estimated, contributing to a comprehensive performance assessment.