Abstract

PARES, Jesica et al. Evaluation of performance parameters of an automated hematology analyzer. Acta bioquím. clín. latinoam. [online]. 2015, vol.49, n.4, pp.399-407. ISSN 0325-2957.

The first step for safety in the results issued by the clinical laboratory is to confirm that all analytical measurement procedures have shown an acceptable analytical performance. A quality performance evaluation of automated hematology analyzer Beckman Coulter LH 750 was performed according to the quality requirements of our laboratory and manufacturer's specifications. The performance parameters evaluated by both manual and automatic mode were: carryover according to CLSI H26-A2 protocol; repeatability, intermediate precision and trueness according to CLSI EP15-A2 protocol and using BIO-RAD controls; linearity according to CLSI EP6-A protocol; quantification limits according to CLSI EP17-A2 protocol; and reference intervals according to CLSI EP28-A3C protocol. Data were analyzed using LinChecker and GraphPad5 programs. The tests performed complied with the requirements stipulated by the manufacturer and the quality requirements of our laboratory like minimal biological variability. Reference intervals for adult individuals were also checked. Consequently, performance evaluation of the automated hematology analyzer showed that the assessed laboratory parameters have acceptable performance.

Keywords : Automated hematology analyzer; Verification; Carryover; Repeatability; Intermediate precision; Trueness; Linearity; Quantification limits; Reference intervals.

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