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Abstract 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 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.
Lewisch et al. (Tue,) studied this question.