A-120 Performance Evaluation of Three Sentinel Diagnostics’ Assays on Roche Cobas c 303 Analytical Unit

Abstract Objective The aim of this study is to evaluate the analytical performances of the following Sentinel Diagnostics’ assays: Total Bile Acid Liquid, Copper, Aldolase, on Roche cobas c 303 analytical unit. Methods Performance evaluation included Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, intra assay precision, inter assay precision, on board reagent stability, prozone effect, instrument correlation following the current CLSI guidelines protocols. Data were evaluated using Microsoft Excel statistical tool Analyse-it. Analytical Measuring Range (AMR) was defined through linearity and sensitivity. Results Summary of the analytical performances for all the assays tested is reported in table below. Conclusion All assays showed good results for all the parameters tested on Roche cobas c 303 analytical unit making these kits very suitable for a routine measurement of these analytes. Parameters Total bile acids Copper Aldolase Sensibility—LOB ≤0.2 μmol/L ≤3.0 μg/dL ≤1.0 U/L Sensibility—LOD ≤0.5 μmol/L ≤5.0 μg/dL ≤2.0 U/L Sensibility—LOQ ≤1.0 μmol/L ≤7.0 μg/dL ≤3.0 U/L Linearity up to 200 μmol/L up to 500 μg/dL up to 30 U/L Precision—Intra assay %CV ≤ 0.8% %CV ≤ 1.7% %CV ≤ 4.1% Precision—Inter assay %CV ≤ 3.2% %CV ≤ 2.6% %CV ≤ 4.1% On board reagent stability up to 60 days up to 60 days up to 30 days No prozone effect up to 820 μmol/L 1500 μg/dL 90 U/L Correlation vs cobas c503 analytical unit n = 110 slope = 0.99 intercept = 0.07 μmol/L r = 0.994 n = 110 slope = 1.00 intercept = 1.94 μg/dL r = 1.000 n = 110 slope = 1.04 intercept = 0.29 U/L r = 0.998