A multi-centre evaluation of the FP-900 analyzing system.

Abstract

The performance of the FP-900 Analyzing system manufactured by Labsystems Oy, Helsinki, Finland, was evaluated in a multi-centre study according to the principle outlined in the 1st Draft of the Standard for Instrument Testing produced by the European Committee for Clinical Laboratory Standards (ECCLS). The FP-900 System comprises a photometer for simultaneous measurement of the absorbance in a nine-compartment cuvette block, and the accessories for handling samples (sampler, simultaneous dispensing of 9 reagent charges, incubator with thermostat and shaker, and centrifuge); the photometer function, printout of results and data processing are programmable with a microprocessor. The performance specifications given by the manufacturer were checked when appropriate. As examples of typical methodologies cholesterol was selected as an end-point absorbance method, creatinine as a fixed-time (two-point) kinetic and aspartate aminotransferase as multi-point, continuous method. The within- and between-laboratory imprecision, deviation from assigned values of commercial control sera, and carry-over were determined. The performance was compared with other analytical systems: Mark I Autoanalyzer and Hitachi 705. The cost, speed and capacity was estimated from the results of the present study. The performance of the analyser and results of applying the ECCLS Draft to actual instrument testing are discussed.