Precision analysis for IgG products and intermediates.

Table 5: Precision analysis for IgG products and intermediates.

Sample	IgG level [mg/mL]	Intra-assay precision		Inter-assay precision
Sample	IgG level [mg/mL]	Mean [mU/mL]	RSD [%]	Mean [mU/mL]	RSD [%]
GG-SD	50	64.7	6.2	69.2	9.2
GGL	100	184	3.9	188	4.1
CUV	200	254	5.8	257	5.3
Plasma pool	5	N/D	N/D	951	5.2
Extract II+III	≈ 7	N/D	N/D	845	4.6
Filtrate II+III	≈ 4	N/D	N/D	19.5	8.8
PptG	50	N/D	N/D	158	6.6

Remarks: Intra- and inter-assay precision (repeatability and intermediate precision) was determined by six repetitions in one run, carried out by one operator, and by repetitions in six independent runs, carried out by three operators.