Section 12.2 (Part 2)

Table 12.3 Requirements for conventional blood typing reagents
Antibody specificity	Specification	Performance evaluation As a minimum, two examples of the following reference cells should be included*	Batch release testing
			Specificity				Potency
			Positive reactors		Negative reactors		Potency
			Cell type	No.	Cell type	No.	Cell type	No.
Anti-A	Normally blue coloured Should equal or exceed potency of reference preparation(s) Should detect variants and subgroups as detailed in the manufacturer's instructions for use	Ax,A₃	A₁	2	B	2	A₁	1
		A cord cells	A₂B	2	O	2	A₂B	2
			Ax*
Anti-B	Normally yellow coloured Should equal or exceed potency of reference preparation(s) Should detect variants and subgroups as detailed in the manufacturer's instructions for use	Bx, B₃, Bv	B	2	A₁	2	B	1
Anti-B		B cord cells	A₁B	2	O	2	A₁B	2
Anti-A,B	Normally clear coloured Should equal or exceed potency of reference preparation(s) Should detect variants and subgroups as detailed in the manufacturer's instructions for use	A₁,A₂, B, A₁B, A₂B	A₁	1	O	4	A₁	1
		Ax,A₃	A₂	2			A₂	2
		Bx, B₃	B	2			B	2
		A and B cord cells	Ax	2
Anti-A₁	Normally clear coloured Should equal or exceed potency of reference preparation(s) Should detect variants and subgroups as detailed in the manufacturer's instructions for use		A₁	2	A₂	2	A₁	2
			A₁B	2	A₂B	2
					B	2
					O	2
Anti-D	Normally clear coloured Should equal or exceed potency of reference preparation(s) Should detect variants and subgroups as detailed in the manufacturer's instructions for use	Weak D (500 sites/cell)	R₁r	2	r'r	1	R₁r	2
		C^w,C^x	R₂r	2	r''r	1
		D^VI type 1, D^VI type 3, D^IV, D^V, D^VII, DFR, DBT, R_O^HAR	Weak D*	2	rr	1
Anti-C	Normally clear coloured Potency titre greater than 4 vs by techniques detailed in manufacturer's instructions for use Should detect variants and subgroups as detailed in the manufacturer's instructions for use	C^w, Cx, r'^S	R₁r	1	R₂R₂	1	R₁r	2
		R₂R_Z	R₁R₂	2	r''r	1
			r'r	1	rr	1
Anti-E	Normally clear coloured Potency titre greater than 4 vs by techniques detailed in manufacturer's instructions for use Should detect variants and subgroups as detailed in the manufacturer's instructions for use	R₁R_Z	R₂r	1	R₁R₁	1	R₂r	2
		E^W	R₁R₂	2	r'r	1
			r''r	1	rr	1
Anti-c	Normally clear coloured Potency titre greater than 4 vs by techniques detailed in the manufacturer's instructions for use Should detect variants and subgroups as detailed in the manufacturer's instructions for use	R₁R_Z, R₁^wR₁	R₁r	2	R₁R₁	3	R₁r	2
			R₁R₂	1
			r'r	1
Anti-e	Normally clear coloured Potency titre greater than 4 vs by techniques detailed in the manufacturer's instructions for use Should detect variants and subgroups as detailed in the manufacturer's instructions for use	R₂R_Z	R₂r	2	R₂R₂	3	R₂r	2
			R₁R₂	1
			r''r	1
Anti-C^w	Normally clear coloured Potency titre greater than 4 vs by techniques detailed in the manufacturer's instructions for use	R₁^wR₁,r'^wr,R₁^wr	R₁^wr or	2	R₁r	1	R₁^wr	2
			R₁^wR₂	2	R₁R₁	1
			r'^wr	1	r'r	1