Multicentre evaluation of the Boehringer Mannheim/Hitachi 717 analysis system.

Area of Science:

• Clinical Chemistry
• Laboratory Instrumentation
• Analytical Performance Evaluation

Background:

• The introduction of new automated clinical chemistry analyzers is crucial for improving laboratory efficiency.
• Evaluating the performance of novel diagnostic equipment is essential before widespread adoption.

Purpose of the Study:

• To assess the analytical performance of the Boehringer Mannheim/Hitachi 717 analysis system.
• To validate the system's precision, linearity, and carryover in a multicentre setting.

Main Methods:

• European multicentre trial involving the Hitachi 717 system.
• Photometric linearity assessment up to an absorbance of 2.8.
• Photometric imprecision evaluation using specific wavelength pairs.
• Within-run and between-day imprecision analysis for 13 analytes.
• Correlation studies with existing analytical instruments.
• Assessment of instrument drift and carryover.

Main Results:

• Photometer linearity confirmed up to 2.8 absorbance.
• Maximal photometric imprecision (CV) was 0.5% at 340/405 nm (absorbance 0.9-2.4).
• Mean within-run imprecision < 2%; mean between-day imprecision < 2.5% for 13 analytes.
• High correlation with comparison instruments and linearity exceeding manufacturer claims.
• No significant drift or carryover detected under experimental conditions.

Conclusions:

• The Hitachi 717 system exhibits high analytical performance and reliability.
• The instrument is user-friendly with simple daily maintenance, facilitating easy adoption.
• This system is a valuable addition for clinical chemistry laboratories.