National Institute of Biologics

Specifications for QC Tests on Anti-A Blood grouping reagent

S.No.	Test(s) Conducted	Specification Transfusion Medicine Tech Manual (2003)
S.No.	Test(s) Conducted	Test RBC	Specification
1.	Titre	A1 A2 A2B	1:256 1:128 1:64
2.	Avidity (Sec) /Intensity	A1 A2 A2B	3-4 Sec/3+ 5-6 Sec/2+ to 3+ 5-6 Sec/4+
3.	Specificity	A1 A2 A2B B O	Positive Positive Positive Negative Negative
4.	Rouleaux	B O	Absent Absent
5.	Haemolysis	A1 A2 A2B B O	Absent Absent Absent Absent Absent
6.	Prozone	A1 A2 A2B	Absent Absent Absent
7.	Physical Appearance and Colour	Clear / Blue Color

Specifications for QC Tests on Anti-B Blood grouping reagent

S.No.	Test(s) Conducted	Specification Transfusion Medicine Tech Manual (2003)
S.No.	Test(s) Conducted	Test RBC	Specification
1.	Titre	B A1B	1:256 1:128
2.	Avidity (Sec) /Intensity	B A1B	3-4 Sec/4+ 5-6 Sec/2+ to 3+
3.	Specificity	B A1B A1 O	Positive Positive Negative Negative
4.	Rouleaux	A1 O	Absent Absent
5.	Haemolysis	B A1B A1 O	Absent Absent Absent Absent
6.	Prozone	B A1B	Absent Absent
7.	Physical Appearance and Colour	Clear and Yellow

Anti-AB Blood grouping reagent

S.No.	Test(s) Conducted	Specification Transfusion Medicine Tech Manual (2003)
S.No.	Test(s) Conducted	Test RBC	Specification
1.	Titre	A1 A2 B	1:256 1:128 1:256
2.	Avidity (Sec) /Intensity	A1 A2 B	3-4 Sec/4+ 5-6 Sec/ 3+ 3-4 Sec/4+
3.	Specificity	A1 B A2 Ax O	Positive Positive Positive Positive Negative
4.	Rouleaux	O	Absent
5.	Haemolysis	A1 B A2 Ax O	Absent Absent Absent Absent Absent
6.	Prozone	A1 B A2	Absent Absent Absent
7.	Physical Appearance and Color	Clear/ Colorless/Cherry Red

Anti-D (IgM) Blood grouping reagent

S.No.	Test(s) Conducted	Specification Transfusion Medicine Tech Manual (2003)
		Test RBC	Specification Immediate Spin 37oC at 30”
1.	Titre	O+ve(R1r) Or O+ve (R1R2)	1:64 – 128 1:64 – 128	1:128 – 256 1:128 – 256
2.	Avidity (Sec) /Intensity	O+ve(R1r) Or O+ve (R1R2)	5-10 Sec/3+ 5-10 Sec/3+
3.	Specificity	O+ve(R1r) or O+ve (R1R2) O neg rr or r’r or r”r	Positive Positive Negative
4.	Rouleaux	O neg rr or r’r or r”r	Absent
5.	Haemolysis	O+ve(R1r) or O+ve (R1R2) O neg rr or r’r or r”r	Absent Absent Absent
6.	Prozone	O+ve(R1r) Or O+ve (R1R2)	Absent Absent
7.	Physical Appearance and Colour	Clear / Colorless

Anti-D (IgM + IgG)) Blood grouping reagent

S.No.	Test(s) Conducted	Specification Transfusion Medicine Tech Manual (2003)
		Test RBC	Specification Immediate Spin 37oC at 30”
1.	Titre	O+ve(R1r) Or O+ve (R1R2)	1:32 – 64 1:32 – 64	1:128 – 256 1:128 – 256
2.	Avidity (Sec) /Intensity	O+ve(R1r) Or O+ve (R1R2)	10-20 Sec/3+ 10-20 Sec/3+
3.	Specificity	O+ve(R1r) or O+ve (R1R2) O neg rr or r’r or r”r	Positive Positive Negative
4.	Rouleaux	O neg rr or r’r or r”r	Absent
5.	Haemolysis	O+ve(R1r) or O+ve (R1R2) O neg rr or r’r or r”r	Absent Absent Absent
6.	Prozone	O+ve(R1r) Or O+ve (R1R2)	Absent Absent
7.	Physical Appearance and Colour	Clear and Colorless

Anti-A1 (Lectin) Blood grouping reagent

S.No.	Test(s) Conducted	Specification Acceptance criteria drawn on NIB data and recommendations of experts
S.No.	Test(s) Conducted	Test RBC	Specification
1.	Titre	A1(2) A1B (2)	1:8 (1+) 1:4(+)
2.	Intensity(sec) / Intensity	A1(2)	2-3 + (within 2”)
3.	Specificity	A1(2) A1B(2) A2(2) A2B(2) B(2) O(2)	Positive Positive Negative Negative Negative Negative
4.	Rouleaux	A2(2) A2B(2) B(2) O(2)	Absent Absent Absent Absent
5.	Haemolysis	A1(2) A1B(2) A2(2) A2B(2) B(2) O(2)	Absent Absent Absent Absent Absent Absent
6.	Prozone	A1(2) A1B (2)	Absent Absent
7.	Physical Appearance and Colour	Clear / Straw Color

Anti- H (Lectin) Blood grouping reagent

S.No.	Test(s) Conducted	Specification Acceptance criteria drawn on NIB data and recommendations of experts
S.No.	Test(s) Conducted	Test RBC	Specification
1.	Titre	O(2) A2 (2) A1 (2)	1:8 (1+) 1:4(+) 1:1 – 1:2 (1+)
2.	Avidity (sec) / Intensity	O(2) A2 (2) A1 (2)	3 + to 4+ (within 3”) 2+ (within 3”) <2+ (within 3”)
3.	Specificity	O(2) A2 (2) A1 (2) Oh(2)	Positive Positive Weak Positive Negative
4.	Rouleaux	Oh(2)	Absent
5.	Haemolysis	O(2) A2 (2) A1 (2) Oh(2)	Absent Absent Absent Absent
6.	Prozone	O(2) A2 (2)	Absent Absent
7.	Physical Appearance and Colour	Clear and Straw Color