Technical features and analytical performances of the Stago Expert Preanalytical Check module for hemolysis, icterus, and lipemia measurement.

Abstract

Objective: Interference caused by hemolysis, icterus, and lipemia (HIL) are a common source of preanalytical errors during coagulation testing. Stago has developed a specific module on its coagulation analyzers to standardize the detection of HIL.

Methods: The aims of this study were to evaluate the accuracy, carryover, and cross-interference of HIL measurement and compare results with those obtained on cobas 8000 modular analyzer series devices (Roche Diagnostics). These evaluations were carried out using Clinical and Laboratory Standards Institute guidance and regulatory study requirements.

Results: We demonstrated the absence of sample carryover through the HIL measurement chamber and excellent accuracy between HIL theoretical and measured concentrations, with an R2 above 0.99 in all cases. We did not detect any cross-interference of bilirubin and lipids to hemoglobin, of hemoglobin and lipids to bilirubin, or for hemoglobin and bilirubin to lipids. We found excellent agreement between HIL on the Stago STA R Max3 and cobas 8000 platforms, with κ coefficients ranging from 0.928 to 0.963.

Conclusions: These results support the implementation of the Stago Expert Preanalytical Check module for HIL interference measurement in routine coagulation laboratory testing.