This document discusses factors to consider when selecting anti-D reagents for RhD typing, including the population being tested, available reagents, and whether weak/partial D detection is required. It also addresses designing a sampling plan for qualifying new anti-D reagents through validation and testing across different sample types and conditions. Finally, it emphasizes having a process for resolving discrepant RhD typing results through additional testing with different reagents or molecular methods.

9. MONOCLONAL IgM/IgG ANTI-D

10. MONOCLONAL IgM/IgG ANTI-D #1 Direct Agglutination - IS

11. MONOCLONAL IgM/IgG ANTI-D #1 Weak D Test - IAT

12. QUOTIENT BIODIAGNOSTICS ANTI-D REAGENTS * Detects DVI on direct agglutination Method Reagent IgM IgG Tube alpha LDM1 Tube delta* LDM1 ESD1M Tube beta LDM3 Tube blend LDM3 ESD1 Gel ID-MTS MS201

21. VALIDATION QUALIFICATION REAGENT MANUFACTURER LABORATORY

25. REQUIREMENTS ACCEPTANCE CRITERIA PREDICTABLE RESULTS

26. VALIDATION/QUALIFICATION How Many Samples Should I Test? SCIENCE

27. SAMPLE PLAN PLANNING Population Sample Account for Sources of Variability

30. Sample Plan Planning Quantitative Approach Page 35

31. Putting the Sampling Plan Together Academic Medical Center Population Sample 10 Spread the sampling plan across the Sources of Variability Rh Neg patients Weak D/Partial D Rh pos patients Mixed Field Samples – 48 hours old 10 10 20 10

32. Putting the Sampling Plan Together Community Hospital Population 20 Sample 4 10 Spread the sampling plan across the Sources of Variability Weak D/Partial D Rh Pos Patients Rh Neg patients Rh Neg Mothers Cord Bloods 6 4

33. Putting the Sampling Plan Together Immunohematology Reference Lab Population Sample 10 Spread the sampling plan across the Sources of Variability Weak D/Partial D Rh Neg patients Mixed Field R 1 r 6 20 10 R 2 r 10 R o 20

35. Anti-D (std method) Negative No Inconclusive Rh Negative Rh Positive Yes No Report Rh pos Test with Different Anti-D Reagents Send out for confirmation No Anti-D (std method) >2+ agglutination score No Yes Yes Matches historical? Matches historical? Y es Partial D Kit or Molecular Typing Rh Discrepancy Algorithm – 1 Example Report Rh neg