Hernández-Huerta FE, Ruíz-Bedolla E, Cruz-López A, Vilchis-Ordoñez A, Gutiérrez-Almanza Z, López-Martínez B, Parra-Ortega I

Language: Spanish
References: 14
Page: 14-26
PDF size: 340.09 Kb.

ABSTRACT

Before the acquisition of a new analytical platform it is necessary to carry out an evaluation of this platform in the actual working conditions of the laboratory. According to the national and international guidelines and regulations, the validation evaluation consisted of the determination of the linearity, precision and veracity of overriding analytes for the clinical chemistry area. The information obtained provided sufficient evidence on the technical and methodological characteristics of Architect c8000^® and Au480^® platforms. Objectives: Evaluated the performance of the Architect c8000^® and AU480^® analytical platforms for the clinical chemistry area by verifying accuracy, veracity and linearity, before to acquisition. Material and methods: Architect c8000^® and Au480^® were used and their accuracy and accuracy were analyzed using the recommendations of the CLSI^® EP15 A2 guide, using Biorad^® Lyphocheck^® reference material in two different concentrations from each methodology studied. For verification of linearity, Architect c8000^® Architect^® brand calibrators and the Calibration Verification/Linearity Kit^®, Validate^®, reference material for Au480^® were used. Results: Intraassay precision (Replicability) in the Architect c8000^® platform was accepted in 4/15 (26%) while for the interassay it was approved in 9/15 (60%) analytes. For the Au480^® platform, intra-assay accuracy (repeatability) was approved in 7/15 (47%) analytes for intraassay was approved in 8/15 (53%) analytes. In verifying the veracity of the Architect c8000^® platform it was obtained that 11/15 (73%) analytes approved the veracity test while for the platform Au480^® 9/15 (60%) analytes approved the veracity test. The results of the linearity for both platforms showed the linearity of the methodologies used in both platforms evaluated had a Pearson correlation coefficient of 0.99. Conclusion: Making a verification allowed Architect c8000^® and Au480^® performance to evaluated under HIMFG clinical laboratory conditions. Not all analytes had an approved result of precision and accuracy, which is a limiting and opportunity for improvement for the platforms before being installed in a clinical chemistry laboratory. Linearity is a requirement that could easily be accepted, and although the entire analytical range of some methodologies was not evaluated, the interest interval could be evidenced for verification purposes.

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