Figure 4.
Effect of activation time on R338L-FIX activity in chromogenic FIX assays. rFIX-WT and rR338L-FIX spiked samples with 50, 100, and 150 IU/dL FIX:C by SynthASil OSA assay were tested alongside SSC Lot 4. Representative standard curves (A) ROX FIX kit and (B) fold change (3 min/8 min) in FIX activity of 3 minutes and standard protocol (8 min) assay reactions. Representative standard curves (C) Biophen FIX kit and (D) fold change (8 min/3 min) in FIX activity for 8 minutes and standard protocol (3 min) assay reactions. Standard curves are fitted with a 4-parameter logistic regression model. Values are mean + SD of ≥3 independent experiments. Means were compared using a paired 2-tailed t test. ∗P < .05 and ∗∗P < .01. ns, not significant; SD, standard deviation; SSC, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis.

Effect of activation time on R338L-FIX activity in chromogenic FIX assays. rFIX-WT and rR338L-FIX spiked samples with 50, 100, and 150 IU/dL FIX:C by SynthASil OSA assay were tested alongside SSC Lot 4. Representative standard curves (A) ROX FIX kit and (B) fold change (3 min/8 min) in FIX activity of 3 minutes and standard protocol (8 min) assay reactions. Representative standard curves (C) Biophen FIX kit and (D) fold change (8 min/3 min) in FIX activity for 8 minutes and standard protocol (3 min) assay reactions. Standard curves are fitted with a 4-parameter logistic regression model. Values are mean + SD of ≥3 independent experiments. Means were compared using a paired 2-tailed t test. ∗P < .05 and ∗∗P < .01. ns, not significant; SD, standard deviation; SSC, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis.

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