A-343 Novel In-Line Hemolysis Detection on a Blood Gas Analyzer for Capillary Samples

Abstract

Abstract Background Point-of-care (POC) blood gas and electrolyte analyzers utilizing whole blood as the predominant sample type are blinded by the presence of hemolysis until today. Moreover, capillary samples are particularly vulnerable to in-vitro hemolysis due to excessive force applied during sample collection. Here, we introduce the GEM Premier 7000 with iQM3 (GEM 7000) which incorporates automatic, in-line hemolysis detection in capillary blood gas samples without a need for additional sample volume or reagents. Methods The hemolysis detection module which is integrated into the disposable GEM cartridge uses acoustophoretic technology and photometric measurements to detect hemolysis in whole blood. In GEM 7000, hemolysis of ≥ 116 mg/dL was found to have significant interference with potassium results. A hemolysis flag is presented as the degree of hemolysis: none (0 - 50 and 51 - 115), mild (116 - 200 and 201 - 300), moderate (301 - 400), and gross (≥401). Due to volume limitations with native capillary samples and challenges in assessing hemolysis levels with a comparator assay, venous blood spiked volumetrically with hemolysate and transferred to capillary devices was used to verify the hemolysis flag performance. An agreement analysis was performed using the Roche cobas hemolysis value. The device's (GEM 7000) ability to flag hemolyzed capillary samples is demonstrated in a simulated clinical setting using native and contrived fingerstick capillary samples. Results Hemolysis verification with transferred capillary samples demonstrated that 98.2% (274/279) of samples were correctly flagged based on the cobas hemolysis value of spiked hemoglobin. Hemolysis in the native capillary samples (N = 235) was primarily distributed in the 0-50 mg/dL range. Additionally, native capillary samples altered using vigorous flea mixing (> 1 minute) showed hemolysis distribution over a wide hemolysis degree (none to gross), and their potassium results were flagged accordingly. Conclusions By providing integrated hemolysis detection in capillary blood sample measurements, the GEM Premier 7000 with iQM3 system can provide quality and confidence in the clinical interpretation of critical results such as potassium.