Local data were collected for precision, linearity, and consistency. Clinically oriented performance goals were defined using the following methods: trueness-published desirable accuracy limits, precision-published desirable biologic variation detection limits - 0.1 percentile of patient test values, linearity - 50% of total error, and consistency-percentage test values crossing key decision points. We evaluated the analytical performance of 24 immunoassays using the Beckman Coulter DxI 800 immunoassay systems at Mayo Clinic, Rochester, MN for trueness, precision, detection limits, linearity, and consistency (across instruments and reagent lots). All rights reserved.Įvaluation of Beckman Coulter DxI 800 immunoassay system using clinically oriented performance goals.Īkbas, Neval Schryver, Patricia G Algeciras-Schimnich, Alicia Baumann, Nikola A Block, Darci R Budd, Jeffrey R Gaston, S J Stephen Klee, George G Copyright © 2015 The Canadian Society of Clinical Chemists. This further expands the utility of the CALIPER database to clinical laboratories using the AU assays however, each laboratory should validate these intervals for their analytical platform and local population as recommended by the CLSI. The majority of CALIPER reference intervals were transferrable to Beckman Coulter AU assays, allowing the establishment of a new database of pediatric reference intervals. It is important to note that the comparisons performed between the Abbott and Beckman Coulter assays make no assumptions as to assay accuracy or which system is more correct/accurate. Most of the transferred reference intervals were sex-specific and were verified using healthy reference samples from the CALIPER biobank based on CLSI criteria. Transferred reference intervals were, in general, similar to previously published CALIPER reference intervals, with some exceptions. We found a strong correlation between Abbott ARCHITECT and Beckman Coulter AU biochemical assays, allowing the transference of the vast majority (94% 30 out of 32 assays) of CALIPER reference intervals previously established using Abbott assays. The new reference intervals were directly verified using up to 100 reference samples from the healthy CALIPER cohort. Transference of CALIPER reference intervals was performed based on the CLSI guidelines C28-A3 and EP9-A2. To expand clinical application of CALIPER reference standards, the present study is aimed at transferring CALIPER reference intervals from the Abbott ARCHITECT to Beckman Coulter AU assays. The CALIPER program has established a comprehensive database of pediatric reference intervals using largely the Abbott ARCHITECT biochemical assays. CLSI-based transference of CALIPER pediatric reference intervals to Beckman Coulter AU biochemical assays.Ībou El Hassan, Mohamed Stoianov, Alexandra Araújo, Petra A T Sadeghieh, Tara Chan, Man Khun Chen, Yunqi Randell, Edward Nieuwesteeg, Michelle Adeli, Khosrow
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