Qualitative test for determination of the K antigen on human red
blood cells.
IVD
Store at 2-8ºC
INTENDED PURPOSE
The reagent is a blood grouping reagent intended to be used to qualitatively determine the
presence or absence of the Kell antigen (KEL1) 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 K antigen on human red cells and causes direct
agglutination (clumping) of human red cells that carry the Kell antigen. No agglutination (no
clumping) generally indicates the absence of the K antigen (see Limitations).
REAGENT
Spinreact Monoclonal Anti-K blood grouping reagent is a low protein reagent containing the
monoclonal IgM antibody, Clone MS-56, diluted in a phosphate buffer containing 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 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 K antigens may be poorly detected by the gel card, microtitre plate and slide
technique. It is recommended that weak K 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.
7. 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.
