Section 12.2 (Part 3)

Table 12.3 Requirements for conventional blood typing reagents - continued
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-K	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	Kk Kp (a+b-)	Kk	4	kk	4	Kk	2
Anti-K		Kk Kp (a-b+)	Kk	4	kk	4	Kk	2
Anti-k	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	K+k+Kp(a+)	Kk	4	KK	4	Kk	2
			Kk Kp(a-)	2
			Kk	2
			Kk Kp(a+b+)
Anti-Fy^a	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	Fy^x	Fy(a+b+)	4	Fy(a-)	4	Fy(a+b+)	2
Anti-Fy^b	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		Fy(a+b+)	4	Fy(b-)	4	Fy(a+b+)	2
Anti-Jk^a	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		Jk(a+b+)	4	Jk(a-)	4	Jk(a+b+)	2
Anti-Jk^b	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		Jk(a+b+)	4	Jk(b-)	4	Jk(a+b+)	2
Anti-S	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	SS,Ss,ss	Ss	4	ss	4	Ss	2
Anti-s	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		Ss	4	SS	4	Ss	2
Anti-M	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	NN He+	MN	4	NN	4	MN	2
Anti-N	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		MN	4	MMS	4	MN	2
Anti-P₁	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		P₁ strong	4	P₁(-)	4	P₁(+)	2
Anti-P₁			P₁ weak	4
Anti-Le^a	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		Le(a+b-)	4	Le(a-)	4	Le(a+)	2
Anti-Le^b	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	A₁B Le(a-b+)	A₁B Le(a-b+)	4	Le(b-)	4	A₁B Le(b+)	2

* For reagents where reactivity against the antigen is claimed