A-363 Effect of Hemolysis on Blood Gas and Chemistry Analytes using GEM Premier 7000 with iQM3 System

Abstract Background GEM Premier 7000 with iQM3 (GEM 7000) which supports integrated hemolysis detection during routine blood gas analysis was introduced in 2024. Hemolysis impact on the GEM 7000 potassium assay has been previously documented (1). This study aimed to characterize the hemolysis interference on blood gas and chemistry analytes that are part of routine blood gas testing. Methods A paired-difference protocol was utilized to evaluate hemolysis interference on the GEM 7000 blood gas and chemistry analytes. The assessment followed CLSI EP07c guidelines and was conducted at two measurand concentrations (low and high). Fresh, heparinized venous blood from normal donors was collected daily over 7 days. For each donor, a base pool of blood was prepared and subsequently divided into two sub-pools, with each adjusted to the target measurand concentration. An aliquot of the donor blood was subjected to ultrasonic lysis to produce hemolysate. The total hemoglobin concentration of the resulting supernatant stock was determined. To prepare test samples, hemolysate was added to the sub-pools, to achieve a plasma free hemoglobin level of approximately 1000 mg/dL. Control samples were prepared simultaneously by adding an equal volume of donor plasma (without hemolysate) to each sub-pool. Six (6) replicates of each test and control samples were analyzed using the GEM 7000 system. The absolute and percentage differences between the mean results of the test and control samples were calculated to evaluate the extent of hemolysis interference on each analyte. Results The results obtained from the paired-difference testing demonstrate that hemolysis interference on the tested analytes was within the interference acceptance limit. Conclusion The study demonstrates the level and the direction of hemolysis impact on routine blood gas and chemistry analytes on GEM 7000. The findings confirm that, aside from potassium, most routine blood gas and chemistry analytes are only slightly affected by the presence of hemolysis on the GEM 7000 system.