Qualitative test for determination of D antigen on human red blood cells.
IVD
Store at 2-8 ºC
INTENDED PURPOSE
The Anti-D reagents are blood grouping reagents intended to be used to qualitatively determine the presence or
absence of the Rh D antigen on the red cells of blood donors or patients requiring a blood transfusion when
tested in accordance with the procedures stated in this IFU.
PRINCIPLE OF THE METHOD
The reagents contain antibodies against the D antigen on human red cells and will cause direct agglutination
(clumping) of human red cells that carry the D antigen and indirect agglutination of test red cells that are
Category DVI in the antiglobulin phase of testing. No agglutination (no clumping) generally indicates the
absence of the D antigen on human red cells (see Limitations).
WEAKENED EXPRESSION OF THE RhD ANTIGEN
The collective term Du is widely used to describe red cells which have a weaker expression of the D antigen
than normal. The term weak D denotes individuals with a reduced number of complete D antigen sites per red
cell. The term partial D denotes individuals with missing D antigen epitopes. DVI is a partial D category which
misses most D epitopes. The reagent will detect most examples of partial and weak D red cells by direct
agglutination, but will not detect DVI cells. This reagent will detect DVI and partial D cells in the IAT phase.
REAGENTS
Spinreact Monoclonal Anti-D blood grouping reagent is a low protein, blended reagent containing human
monoclonal IgM and IgG anti-D diluted in a phosphate buffer containing sodium chloride (0.9 g%), bovine
albumin (2.0 g%) and macromolecular potentiators (1,5 g%). When typing patient samples, this reagent will
directly agglutinate Rh D positive cells, including majority of variants (but not DVI) and a high proportion of weak
D (Du) phenotypes when using the recommended techniques. The reagents do not contain or consist of CMR
substances, or endocrine disrupting substances or that could result in sensitisation or an allergic reaction by the
user. The reagent is supplied at optimal dilution for use on patient samples with all procedures stated below
without need for further dilution or addition. For lot reference number and expiry date see Vial Label.
PRECAUTIONS
1. The reagents is intended for in vitro diagnostic use only.
2. If a reagent vial is cracked or leaking, discard the contents immediately.
3. Do not use the reagent past the expiration date (see Vial Label).
4. Do not use the reagent if a precipitate is present.
5. Protective clothing should be worn when handling the reagent, such as disposable gloves and a laboratory coat.
6. The reagents have been filtered through a 0.2 µm capsule to reduce the bio-burden, but is not supplied
sterile. Once a vial has been opened the contents should remain viable up until the expiry date as long as there
is no marked turbidity, which can indicate reagent deterioration or contamination.
7. The reagents contain 0.1% sodium azide. Sodium azide may be toxic if ingested and may react with lead
and copper plumbing to form explosive metal azides. On disposal flush away with large volumes of water.
8. Materials used to produce the products were tested at source and found to be negative for HIV 1+2 and HCV
antibodies and HBsAg using approved microbiological tests.
9. No known tests can guarantee that products derived from human or animal sources are free from infectious
agents. Care must be taken in the use and disposal of each vial and its contents.
10. For information on disposal of the reagent and decontamination of a spillage site see Material Safety Data
Sheets, available on request.
NOTES
1. It is recommended that a positive control (ideally R1r cells) and a negative control (ideally rr cells) be tested
in parallel with each batch of tests. Tests must be considered invalid if controls do not show expected results.
2. When typing red cells from a patient who is diagnosed with a disease that causes the red cells to become
coated with antibody or other proteins (such as HDN, AIHA), it is important to test the patients red cells using
reagent negative control. Tests must be considered invalid if red cells are agglutinated using Monoclonal D
Negative Control.
3. Test samples for category DVI determination by the Indirect Antiglobulin Test, Coombs Bio-Rad-ID and
Coombs Ortho BioVue Techniques only.
4. Weak and variant D antigens are poorly detected by gel card, microtitre plate and slide techniques. It is
recommended that that weak and partial variants are tested using the tube test technique.
5. The antiglobulin tube technique can only be considered valid if all negative tests react positively with IgG
sensitised red cells.
6. Before use, let the reagent warm up to room temperature. As soon as the reagent has been used, put the
reagent back in the storage at 2-8 ºC.
7. In the procedures one volume is approximately 50 µL when using the vial dropper provided.
8. The use of reagents and interpretation of results must be carried out by properly trained and qualified
personnel in accordance with requirements of the country where the reagents are in use.
9. The user must the determine suitability of the reagents for use in other techniques.
STORAGE
Reagent vials should be stored at 2 – 8 ºC on receipt. Prolonged storage at temperatures outside this range may
result in accelerated loss of reagent reactivity. This reagent has undergone transportation stability studies at 37
ºC and -25ºC as described in document BS EN ISO 23640:2015.
