5.8.2 Determination of Rh Type for All Collections The Rh type shall be determined for each collection with anti-D reagent. If the initial test with anti-D is negative, the blood shall be tested using a method designed to detect weak D. When either test is positive, the label shall read “ Rh POSITIVE.”
MONOCLONAL IgM/IgG ANTI-D #1 Direct Agglutination - IS
MONOCLONAL IgM/IgG ANTI-D #1 Weak D Test - IAT
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
Anti-D delta ALBAclone® RECOMMENDED FOR DONOR TESTING
“ This monoclonal IgM anti-D will directly agglutinate red blood cells from all known D categories including DVI and, therefore, is ideally suited for RhD grouping of donor samples. The reagent is not recommended for the RhD grouping of patient samples for the purpose of transfusion. ”
Anti-D blend ALBAclone® (Human/Murine Monoclonal IgM/IgG) For Slide and Tube Techniques
“ This monoclonal anti-D will directly agglutinate red blood cells from most weak D and partial RhD except DVI and, therefore, is suitable for RhD grouping of patient samples. This reagent will also detect DVI and weak D by IAT and, therefore, is also suitable for RhD grouping of donor samples.”
What Is Your Current Process & Procedure for RhD Typing?
Direct Agglutination IAT or Weak D Testing +/- Pt’s cells Anti-D Spin & Read 3-4+ D+ D- Incubate @ 37C, Wash, Add Anti-IgG Spin & Read If still (-) or < 2+ Report D- If now 2+ or more Report D+ If 1-2+
The laboratory must verify for each method the performance specifications for accuracy, precision, clinical sensitivity, clinical specificity, and any other applicable performance characteristic appropriate for measuring test performance.
I want to be ___% certain that ___% of times the process/test is performed that I get the expected result.
In choosing this sampling plan, I am willing to accept __ (#) of failures in my validation.
Sample Plan Planning Quantitative Approach Page 35
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
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
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
Develop a Process for Handling Discrepant RhD Typing
What testing will be performed to interpret results
Different anti-D clones
Partial D Kit
How results will be reported
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