A-129 Evaluation of the Analytical Performance of Magnesium and Calcium General Chemistry Assays on the Atellica CI Analyzer

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 70; no. Supplement_1
• Main Authors: Carter, R H, Varhue, W, Gupta, P, Shalhoub, V, Camacho, J, Snyder, J
• Format: Journal Article
• Language: English
• Published: 02.10.2024
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1093/clinchem/hvae106.128

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 Magnesium (Mg) and Calcium (Ca), Assays on the Atellica CI Analyzer. Methods The Atellica CI Mg and Ca assays use the same reagents and calibrators as the Atellica CH assays. Precision studies were performed according to CLSI EP05-A3 using serum and urine 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. MC studies were performed according to CLSI EP09-A3. Individual human urine and serum samples were analyzed using the Atellica CH and Atellica CI Analyzers. LoB, LoD, LoQ were determined according to CLSI EP17-A2. Results Representative precision and MC results observed across indicated sample ranges are listed for each assay in the table below. Over the two assays tested, repeatability and within-lab %CVs were <4.9%. Overall, slopes determined using the Deming linear regression model were approximately equal to 1. LoB, LoD, LoQ for serum Mg were 0.07 mg/dL (0.03 mmol/L), 0.11 mg/dL (0.05 mmol/L), and 0.50 mg/dL (0.21 mmol/L), and for urine Mg, 0.07 mg/dL (0.03 mmol/L), 0.14 mg/dL (0.06 mmol/L), and 1.00 mg/dL (0.41 mmol/L). LoB and LoD for serum Ca were 0.2 mg/dL (0.05 mmol/L) and 0.3 mg/dL (0.08 mmol/L), and for urine Ca, 0.3 mg/dL (0.08 mmol/L) and 0.5 mg/dL (0.13 mmol/L), respectively. Linearity was demonstrated for both assays. Conclusions Atellica CH Mg and Ca Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on the Atellica CH Analyzer.