Figure 5.
Supplemental FX causes an apparent increase in 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 were tested alongside SSC Lot 4. ROX FIX and Biophen FIX assays were performed according to the standard protocol or with FX supplemented to 180 nM. (A) ROX FIX representative standard curves; (B) fold changes (180 nM/34 nM FX) of interpolated FIX activity; (C) Biophen FIX representative standard curves; and (D) fold changes (180 nM/60 nM FX) of interpolated FIX activity. Standard curves are fitted with a 4-parameter logistic regression model. Values are mean ± SD, n ≥3 independent experiments. Means were compared using a paired 2-tailed t test. ∗P < .05 and ∗∗P < .01. ns, not significant; SSC, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis.

Supplemental FX causes an apparent increase in 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 were tested alongside SSC Lot 4. ROX FIX and Biophen FIX assays were performed according to the standard protocol or with FX supplemented to 180 nM. (A) ROX FIX representative standard curves; (B) fold changes (180 nM/34 nM FX) of interpolated FIX activity; (C) Biophen FIX representative standard curves; and (D) fold changes (180 nM/60 nM FX) of interpolated FIX activity. Standard curves are fitted with a 4-parameter logistic regression model. Values are mean ± SD, n ≥3 independent experiments. Means were compared using a paired 2-tailed t test. ∗P < .05 and ∗∗P < .01. ns, not significant; SSC, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis.

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