Qualitative test for determination of the C and/or D and/or E antigen on
human red blood cells.
IVD
INTENDED PURPOSE
The reagent is a blood grouping reagent intended to be used to qualitatively determine the
presence or absence of the C antigen (RH2) and/or D antigen (RH1) and/or E antigen (RH3) 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 reagent contains antibodies to the C and D and E antigens on human red cells and will cause
direct agglutination (clumping) of human red cells that carry the C and/or D and/or E antigen. No
agglutination (no clumping) generally indicates the absence of the corresponding Rh antigen (see
Limitations)
REAGENTS
Spinreact Monoclonal IgM Anti-Rh blood grouping reagents are low protein reagents containing
human monoclonal antibodies diluted with sodium chloride, bovine albumin and macromolecular
potentiators (4.0 g%). 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. Each
reagent is supplied at optimal dilution for use with all procedures stated below without need for
further dilution or addition. For lot reference number and expiry date see Vial Label.
Reagent Cell Line / Clone
Anti-C+D+E MS-24 + RUM-1 + MS-258
PRECAUTIONS
1. The reagents are 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 reagents past the expiration date (see Vial Label).
4. Do not use the reagents if a precipitate is present.
5. Protective clothing should be worn when handling the reagents, 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 a positive control (ideally heterozygous) and a negative control 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 it is important that a reagent negative control is included
since the macromolecular potentiators in the reagent may cause false positive reactions with IgG
coated cells.
3. Weak Rhesus antigens may be poorly detected by the gel card, microtitre plate and slide
technique. It is recommended that weak Rhesus antigens are tested using the tube test
technique.
4. Before use, let the reagent warm up to room temperature. As soon as the reagent has been
used, put the reagent back in storage at 2-8 ºC.
5. In the procedures one volume is approximately 50µL when using the vial dropper provided.
6. 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.
The user must the determine suitability of the reagents for use in other techniques.
STORAGE
Reagent vials should be stored at 2 - 8ºC 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.
