B-029 Evaluation of the Analytical Performance of Creatine Kinase, Lactate dehydrogenase L-P, Myoglobin Assays on the Atellica CI Analyzer

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 Creatine Kinase (CKL), Lactate dehydrogenase L-P (LDLP), and Atellica IM Myoglobin (MYO) Assays on the Atellica CI Analyzer. Methods The Atellica CI assays use the same reagents and calibrators as the Atellica CH and IM assays. Precision studies were performed according to CLSI EP05-A3 using 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. MC studies were performed according to CLSI EP09-A3. Individual human serum samples were analyzed using the Atellica CH, Atellica IM, and Atellica CI Analyzers. LoB, LoD, LoQ were determined according to CLSI EP17-A2. Results Representative precision and MC results across indicated sample ranges are listed for each assay in the table. Over the three assays tested, %CVs for repeatability were 2. 6% and %CVs for within-lab were 4. 5%. Slopes determined using the Deming linear regression model were approximately equal to 1. LoB, LoD, LoQ were 5, 8, and 15 U/L for CKL; 2, 4, and 11 U/L for LDLP; and 3, 00, 6. 00, and 6. 00 ng/mL (µg/L) for MYO assays, respectively. Conclusions Atellica CH CKL and LDLP, and Atellica IM MYO Assays on the Atellica CI Analyzer demonstrated good precision and equivalent performance to the same assays on Atellica IM and CH Analyzers.