Abstract

GUGLIELMONE, Ricardo et al. Method verification in a certified laboratory and internal quality control planification. Acta bioquím. clín. latinoam. [online]. 2011, vol.45, n.2, pp.335-347. ISSN 0325-2957.

The process of method verification (MV) generates data about the performance of a measuring system in current laboratory working conditions; later, the information obtained is compared to the specifications issued by the assay manufacturer and International Regulating Organizations. The objectives of this study were: 1) to apply evaluation protocols established by international guidelines (CLSI, Clinical Laboratory Standards Institute) to verify the correct performance of the methodologies under analysis; 2) to design and implement a strategy of internal quality control (IQC) that allows evaluating the stability of the measuring system in time. Glucose, creatinine and lactate deshidrogenase were subject to analysis. Verification of precision, trueness, linearity detection limit, instrument comparison and reference values were performed under the provisions of CLSI EP-15A2, EP6A, EP17-A, EP9-A2 and C28-A2 guidelines, respectively. For every assay, the procedures indicated by the manufacturer were respected, as well as the quality requirements chosen for total allowed error. An operative point was obtained and adequate ICQ rules for monitoring the performance of those methodologies were established. With the results obtained, a quality matrix was built for a monthly follow-up of the evaluated parameters. The acceptability of the evaluated analytical parameters was proved by the application of MV procedures. Furthermore, the MV enabled to design and implementation of an ICQ strategy to test the analytical stability of the measuring systems, in the analytical safety environment required for accredited methods.

Keywords : Methods verification; Quality requirements; Internal quality control; Operative point.

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