The results of our study, encompassing a comprehensive analytical validation of hemolysis index (HI) measurement on the novel GEM Premier 7000 blood gas analyzer, demonstrated very low intra-assay imprecision and a wide, linear measurement range, extending up to 7.27 g/L. We observed excellent comparability with a reference clinical chemistry platform (Cobas c702), with Spearman’s correlation of 0.990 for continuous HI values, statistically negligible bias, and almost optimal accuracy at the clinically relevant HI thresholds of 0.50 and 1.16 g/L. Our findings confirm that GEM Premier 7000 effectively detects hemolysis in whole blood samples without requiring plasma separation – a significant innovation for point-of-care (POC) testing.
Analytical validation of hemolysis detection on GEM Premier 7000
Pighi, Laura;Salvagno, Gian Luca;Lippi, Giuseppe
In corso di stampa
Abstract
The results of our study, encompassing a comprehensive analytical validation of hemolysis index (HI) measurement on the novel GEM Premier 7000 blood gas analyzer, demonstrated very low intra-assay imprecision and a wide, linear measurement range, extending up to 7.27 g/L. We observed excellent comparability with a reference clinical chemistry platform (Cobas c702), with Spearman’s correlation of 0.990 for continuous HI values, statistically negligible bias, and almost optimal accuracy at the clinically relevant HI thresholds of 0.50 and 1.16 g/L. Our findings confirm that GEM Premier 7000 effectively detects hemolysis in whole blood samples without requiring plasma separation – a significant innovation for point-of-care (POC) testing.
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