COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OF BLOOD GROUP ANTIGENS IN THE ABO, RH, KELL, DUFFY AND KIDD BLOOD GROUP SYSTEMS
ANNEX IISupplementary provisions
ANNEX II COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OF BLOOD GROUP ANTIGENS IN THE ABO, RH, KELL, DUFFY AND KIDD BLOOD GROUP SYSTEMS Scope This Annex applies to devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems. Table 1 applies to performance evaluation of devices detecting blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems. Table 2 applies to manufacturer’s batch-to-batch consistency testing of reagents and reagent products to determine blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems (test reagents, control materials). Table 1. Performance evaluation of devices detecting blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems Reagent specificity Number of tests per method claimed by the manufacturer Total number of specimens to be tested for a launch device Total number of specimens to be tested for a new formulation, or use of well-characterised reagents General qualification criteria Specific qualification criteria Acceptance criteria Anti-ABO1 (Anti-A), Anti-ABO2 (Anti-B), Anti-ABO3 (Anti-A,B) ≥500 ≥3 000 ≥1 000 Clinical specimens: 10 % of the test population Neonatal specimens: > 2 % of the test population ABO specimens shall include > 40 % A and B antigen positive specimens which may include specimens from group A, group B and group AB All of the reagents shall show comparable performance to state-of-the-art CE marked devices with regard to claimed reactivity of the device. For CE marked devices where the application or use has been changed or extended, further testing shall be carried out in accordance with the requirements outlined in column 2 above (“Number of tests per method claimed by the manufacturer”). Anti-RH1 (Anti-D) ≥500 ≥3 000 ≥1 000 Performance evaluation of Anti-D reagents shall include tests against a range of weak RH1 (D) and partial RH1 (D) specimens, depending on the intended use of the product. Weak and/or partial D cells shall account for > 2 % of RH1 (D) positive specimens. Anti-RH2 (Anti-C), Anti-RH4 (Anti-c), Anti- RH3 (Anti-E) ≥100 ≥1 000 ≥200 Anti-RH5 (Anti-e) ≥100 ≥500 ≥200 Anti-KEL1 (Anti-K) ≥100 ≥500 ≥200 Anti-JK1 (Jk a ), Anti-JK2 (Jk b ) ≥100 ≥500 ≥200 Anti-FY1 (Fy a ), Anti-FY2 (Fy b ) ≥100 ≥500 ≥200 Note: Positive specimens used in the performance evaluation shall be selected to reflect variant and weak antigen expression. Table 2. Manufacturer’s batch-to-batch consistency testing of reagents and reagent products to determine blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems 1. Test reagents Blood group reagents Minimum number of control cells to be tested as part of specificity testing Acceptance criteria Positive reactions Negative reactions Each batch of reagent shall exhibit unequivocal positive or negative results by all techniques claimed by the manufacturer in accordance with the results obtained from the performance evaluation data. A1 A2B Ax B O Anti-ABO1(Anti-A) 2 2 2 ( 1 ) 2 2 B A1B A1 O Anti-ABO2(Anti-B) 2 2 2 2 A1 A2 Ax B O Anti-ABO3(Anti-A,B) 2 2 2 ( 1 ) 2 4 R1r R2r WeakD r’r r”r rr Anti-RH1 (Anti-D) 2 2 2 ( 1 ) 1 1 1 R1R2 R1r r’r R2R2 r”r rr Anti-RH2 (Anti-C) 2 1 1 1 1 1 R1R2 R1r r’r R1R1 Anti-RH4 (Anti-c) 1 2 1 3 R1R2 R2r r”r R1R1 r’r rr Anti-RH3 (Anti-E) 2 1 1 1 1 1 R1R2 R2r r”r R2R2 Anti-RH5 (Anti-e) 2 1 1 3 Kk kk Anti-KEL1 (Anti-K) 4 3 Jk(a+b+) Jk(a–b+) Anti-JK1 (Anti-Jk a ) 4 3 Jk(a+b+) Jk(a+b–) Anti-JK2 (Anti-Jk b ) 4 3 Fy(a+b+) Fy(a–b+) Anti-FY1 (Anti-Fy a ) 4 3 Fy(a+b+) Fy(a+b–) Anti-FY2 (Anti-Fy b ) 4 3 Note: Polyclonal reagents shall be tested against a wider panel of cells to confirm specificity and exclude presence of unwanted contaminating antibodies. 2. Control materials (red cells) The phenotype of red cells used in the control of blood typing reagents listed above shall be confirmed using an established device(s). ( 1 ) Only where reactivity against these antigens is claimed.