Qualitative test for determination of the C,c,E,e antigen on human red blood cells.
IVD
Store at 2-8ºC
INTENDED PURPOSE
The Rh reagents are blood grouping reagents intended to be used to qualitatively determine
the presence or absence of Rh antigens 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 to the appropriate Rhesus antigen on human red cells and will
cause direct agglutination (clumping) of red cells that carry the corresponding Rh 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.
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 patients known or suspected to have auto-antibodies, protein
abnormalities or a positive Direct Antiglobulin Test (DAT), it is important that a reagent
negative control is tested in parallel.
3. Weak Rh antigens may be poorly detected by the gel card, microtitre plate and slide
technique. It is recommended that weak Rh 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 the storage at 2-8 ºC.
5. In the Procedures one volume is approximately 50 µL 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.
