Evaluation of analytical performance & quality specification of urine biochemical analytes

Abstract

Urinary biochemical analytes are very important tools for clinical decision making. Total allowable error (TEa) by integrating internal (IQC) and external (EQC) quality control performances are used to evaluate the performance of urinary biochemical analytes along with quality specifications strategy. : Alternate 6 months Coefficient of Variation (CV%) and External Quality Assurance Scheme (EQAS) bias% data for urinary biochemistry analytes were collected for the year 2022. TEa calculated for each analyte was calculated based on average CV% and bias%. Total TEa calculated values are compared with optimal, minimal and desirable TEa of each analyte. : TEa values of urinary biochemistry analytes were performing good and fulfilled minimal, desirable and optimal quality requirements except urine creatinine which did not fulfill the minimal standards.: TEa is an excellent quality management tool and quantitatively evaluates analytical performance. The accurate results generated are useful for clinicians for decision-making.