A-091 Evaluation of the Analytical Performance of the New Prealbumin Assay on the Atellica CH Analyzer

Background Analytical performance studies for the new Atellica® CH Prealbumin (PALB) Assay were performed to evaluate precision, detection capability, linearity, and method comparison with the Atellica® CH Prealbumin (PreAlb) Assay. Methods Precision was conducted with 3 reagent lots per CLSI EP05-A3. Daily, two runs were performed, separated by >2 hours with 2 replicates/run, for 20 days, using normal human serum, QC material (Bio-Rad Liquid Assayed Multiqual® Level 3), and normal human serum spiked with prealbumin (Cliniqa Prealbumin spike). Reproducibility was determined per CLSI EP05 A3 and internal protocols. Samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots. Method comparison (MC) studies were conducted with 3 reagent lots per CLSI EP09C-ED3. Individual native serum samples were tested in singlicate on two Atellica® CH analyzers. Passing & Bablok regression used PALB assay as test assay and PreAlb assay as predicate assay. Where needed, MC samples were spiked with concentrated prealbumin (Clinqa Prealbumin spike) to cover the assay measuring interval. LoB and LoD testing were conducted with 3 reagent lots per CLSI EP17-A2. For LoB, four blank samples were run (n=6) per day for three days, total 72 per reagent lot. For LoD, and additional four low samples were run (n=6) per day for three days on 3 lots, on one instrument, total 72 per lot. Linearity studies followed CLSI EP06 A; low and high pools were diluted and spiked (9 levels; n=5 per level). Results The linear range was 3.0-70.0 (30-700) mg/dL (mg/L). Results are presented in the table below for detection capability, repeatability, and method comparison. Reproducibility was 2.7-6.5% at 15.0-58.4 mg/dL (150-584 mg/L). Conclusions The PALB assay detection capability, precision, linearity, and method comparison with the PreAlb assay results were acceptable. This assay is fit for use in a clinical laboratory.