title: Axon clinical chemistry analyzer evaluated according to ECCLS protocol.
abstract: We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.
authors.affiliation: Laboratorio di Biochimica Clinica ed Ematologia, Ospedale Cà Granada, Niguarda, Milano, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Brenna
authors.forename: L
authors.initials: L
authors.lastname: Prencipe
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation; D002624:Chemistry, Clinical / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D011786:Quality Control