Abstract

IntroductionTotal bilirubin tests are highly demanded in clinical laboratories. Since icteric index (I-index) has zero cost, we aimed to evaluate its clinical utility and cost-effectiveness to determine if total bilirubin is necessary to be tested. We took into account if haemolysis could interfere to icteric index determination.Material and methodsRetrospectively we reviewed I-index results in two cohorts (43,372 and 8507 non-haemolysed and haemolysed samples, respectively). All determinations were done using Alinity c chemistry analysers (Abbott Diagnostics). Receiver operating characteristic (ROC) curve was used to determine the optimal index cut-off to discriminate between normal and abnormal bilirubin concentration (20.5 µmol/L).ResultsThe ROC curve analysis suggested 21.4 µmol/L as the optimal I-index cut-off but differences in sensitivity and specificity were detected between patient derivation. For rejecting purpose, 15.4 µmol/L and 17.1 µmol/L I-index thresholds were selected based on patient derivation (inpatients and emergency room; and primary care and outpatients, respectively) with 97% sensitivity and 0.25% false negative results. Sensitivity was much lower in haemolysed samples. We selected 34.2 µmol/L I-index as threshold to detect hyperbilirubinemia with 99.7% specificity and 0.26% false positive results, independent of haemolysis. With the icteric index cut-offs proposed, we would save 66% of total bilirubin requested and analyse total bilirubin in around 2% of samples without total bilirubin requested.ConclusionsThis study supports the use of I-index to avoid bilirubin determination and to identify patients with hyperbilirubinemia. This work considers that the economic and test savings could help to increase the efficiency in clinical laboratories.

Highlights

  • Total bilirubin tests are highly demanded in clinical laboratories

  • This study supports the use of icteric index (I-index) to avoid bilirubin determination and to identify patients with hyperbilirubinemia

  • This study aim to evaluate the clinical utility and cost-effectiveness of I-index as, firstly, screening of Total bilirubin (TBil) in order to reject the determination of this parameter and, secondary, detection of hyperbilirubinemia in those cases without TBil ordered

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Summary

Introduction

Total bilirubin tests are highly demanded in clinical laboratories. Since icteric index (I-index) has zero cost, we aimed to evaluate its clinical utility and cost-effectiveness to determine if total bilirubin is necessary to be tested. Haemolysis, icterus, lipaemia (HIL) serum indices have been implemented in clinical laboratories, according to CLSI C56A guideline [1]. Clinical chemistry analysers measure HIL indices under different wavelengths, providing approximate concentrations of haemoglobin, bilirubin and lipids in samples. These measurements are cheap, fast and objective and, more important, reduce the possibility of errors in the preanalytical phase which increases the patient safety [2,3,4].

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