Qualitative test for determination of A and/or B antigens on human red blood cells
IVD
Store at 2-8 ºC
INTENDED PURPOSE
The ABO reagents are blood grouping reagents intended to be used to qualitatively determine the presence
or absence of the A and or B 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 against the appropriate A and/or B antigen on human red cells and will
cause direct agglutination (clumping) of red cells that carry the corresponding ABO antigen. No agglutination
generally indicates the absence of the corresponding ABO antigen on human red cells (see Limitations).
REAGENTS
Spinreact Monoclonal IgM ABO blood grouping reagents contain mouse monoclonal antibodies diluted in a
phosphate buffer containing sodium chloride, EDTA and bovine albumin. 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 the procedures
stated below without the 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 are 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. 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.
9. 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 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. Since these reagents do not contain macromolecular potentiators, it is very unlikely that false positive
reactions are caused with IgG coated cells.
3. Blood specimens of weak A or B subgroups (e.g Ax) may give rise to false negative or weak reactions
when tested using slides, microtitre plates or gel cards. It is advisable to re-test weak subgroups using
the tube technique.
4. Individuals older than six months should have their ABO blood-grouping results confirmed by testing
their serum or plasma against known group A1 and B cells before their ABO blood group can be
confirmed.
5. 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 2-8ºC.
6. In the Procedures one volume is approximately 50µL when using the vial dropper provided.
7. The use of the reagents and the interpretation of results must be carried out by properly trained and
qualified personnel in accordance with the requirements of the country where the reagents are in use.
8. The user must determine the 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.
