Abstract
Abstract Background The Atellica® CI Analyzer is an automated, mid-throughput, integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM assays. This study was designed to evaluate the analytical performance of the Atellica® CH Prealbumin (PALB) and β2-Microglobulin (B2M) Assays on the Atellica CI Analyzer. Methods The Atellica CI PALB and B2M assays use the same reagents and calibrators as the Atellica CH assays. Precision and method comparison (MC) were used as performance indicators for the Atellica CI Analyzer. Precision studies were performed according to CLSI EP05-A3 using native, QC, and contrived human serum samples. One aliquot of each sample pool was tested in duplicate in two runs per day >2 hours apart on each analyzer for 20 days. Method comparison (MC) studies were performed per CLSI EP09-A3. Individual serum samples were analyzed using the Atellica CH and Atellica CI Analyzers. Linearity and verification of detection capability studies were demonstrated for both assays. Results Representative precision, and MC results are presented in the table. Over the two assays tested, repeatability and within-lab %CVs were <4.0% and <4.6%, respectively. Slopes determined using the Deming linear regression model were approximately equal to 1. The Atellica CH PALB assay is linear from 3.0-70.0 mg/dL (30-700 mg/L); LoB, 1.1 mg/dL (11 mg/L); LoD. 1.9 mg/dL (19 mg/L); LoQ, 3.0 mg/dL (30 mg/L). The Atellica CH B2M assay is linear from 0.25-18.00 mg/L; LoB, 0.10 mg/L; LoD, 0.20 mg/L. Conclusions Atellica CH PALB and B2M Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on the Atellica CH Analyzer.
Published Version
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