Abstract
Abstract Objective The aim of this study is to evaluate the analytical performances of the following Sentinel Diagnostics’ assays: Zinc, Total Bile Acid Liquid on Roche cobas c 503 analytical unit. Background Zinc is a component of metalloenzymes involved in nucleic acid and protein synthesis, therefore it is a necessary complement for cell replication. Acute zinc deficiency can result in skin lesions, irritability, loss of hair, growth retardation. Also impaired immunological function is associated with zinc insufficiency. Total Bile Acids (TBA) are metabolized in the liver and hence serve as a marker for liver function. Serum TBA are increased in patients with acute hepatitis, chronic hepatitis, liver sclerosis and liver cancer. Methods Performance evaluation included Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ), linearity, intra assay precision, inter assay precision, calibration stability, on board reagent stability, and 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 both the assays tested is reported in table below. Conclusions Both assays showed good results for all the parameters tested on Roche cobas c 503 analytical unit making these kits very suitable for a routine measurement of these analytes.
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