Table 1.

Comparable mean spike recovery for rFVIIIFc and Advate® by the one-stage clotting assay

	Label activity, IU mL−1	Mean recovery, % of label (n = 29–30 per level)	Mean intra-laboratory % CV (n = 3 per laboratory)	Inter-laboratory % CV (n = 30)
Advate®	0.80	96.7	6.3	10
	0.20	110.2	7.8	19
	0.05	118.1	7.4	34
rFVIIIFc	0.87	94.6	6.0	16
	0.22	106.0	8.7	17
	0.054	115.7	10.3	31

Conducted in 30 laboratories.

CV, coefficient of variance; rFVIIIFc, recombinant factor VIII Fc fusion protein.