Principle:

For the purpose of typing blood donors, we want to detect weak and partial D types and consider them as D-positive since even a portion of the D molecule is immunogenic and sensitization to it may cause anti-D hemolytic disease of the newborn.

Background:

Ortho Diagnostics Reagents use three different monoclonal antibody cocktails that react variably with the antigen D (Rh1)—these are found on TWO (2) cards:  Anti-A/B/A,B/D/CDE and Anti-DVI:

Anti-D/Anti-RH1—IgM monoclonal antibody clone D7B8 can detect most examples of weak and partial D including weak D types 1, 2, 3, 4.0, and D categories II, III, IV, V, VII, DBT, and R₀^Har.  It does NOT detect category VI.  Retest positive reactions of 2+ or less by an alternate method.  It may show different serologic activity compared to other D typing reagents.

Anti-CDE/Anti-RH1,2,3—IgM monoclonal blend of clone MS24 (anti-C), clone MAD2 (Anti-D), and clone C2 (Anti-E) can detect most cells expressing C, D, or E antigens.  Most examples of partial D including DVI and weak D express C or E antigens and will be detected directly by the included anti-D or indirectly by the anti-C or anti-E in the cocktail.  It does NOT detect Rh:33 (R₀^Har).

Anti-DVI/Anti-RH1 will agglutinate cells with a DVI phenotype, analogous to our previous DVI+ reagents.

Policy:

1. Follow the manufacturer’s instruction for storage, handling, and usage of all reagents.
2. If the D-control is positive, the reactions are indeterminate, repeat by another method.
3. For donors, run all three anti-D reagents listed—do not use the patient typing algorithm or reagents.
4. Use the following table for interpretation and further actions if needed:

Pattern #	Anti-D/D7B8	Anti-CDE	Anti-DVI	D-Interpretation
1	Positive	Positive	Positive	D-positive
2	Positive	Positive	Negative	Do additional testing
3	Positive	Negative	Negative	Do additional testing
4	Negative	Negative	Positive	Do additional testing
5	Positive	Negative	Positive	Do additional testing
6	Negative	Positive	Positive	D-positive, probable DVI variant
7	Negative	Positive	Negative	D-negative, probable rare genotypes r’ and/or r’’
8	Negative	Negative	Negative	D-Negative

If the reaction is 2+ or less with the Ortho anti-D/D7B8 reagent or 1+ with either the CDE or DVI reagents is patterns 2, 3, 4, or 5 above, repeat by another manufacturer’s reagents, including DVI+ and DVI- sensitivities.

Medinfo-Ortho interface settings for Blood Donor Center:

Anti-D/D7B8	Anti-CDE	D-Interpretation
3,4	1,2,3,4	D-positive
3,4	0	Indeterminate
0	0	Indeterminate
0	1,2,3,4	Do DVI REFLEX
REFLEX DVI		If DVI-pos, then D-positive
REFLEX DVI		If DVI-neg, then D-negative
0	0	D-negative
~	~	Indeterminate

~ means any other result

Note all of the following:

1. No reagents may be able to detect all D variants.
2. ~ means any other value for that reagent (e.g. anti-D/D7B8 reactions 1, 2, mf, hemolyzed)
3. Note that this new algorithm makes a 2+ reactivity with Anti-D/D7B8 as indeterminate.

References:

1. Product Insert, Anti-A/B/A,B/D/CDE/Control Card, Revised January, 2015, Ortho Clinical Diagnostics, High Wycombe, Buckinghamshire/UK
2. Publication J55650_EN, Instructions for Use, Blood Grouping Reagent Ortho Sera Anti-D(DVI) (Anti-RH1), Version 2.0, 2015-07-30, Alba Bioscience, Edinburgh, UK
3. Standards for Blood Banks and Transfusion Services, 29^th Edition, AABB, Bethesda, MD, USA