ANTI-D (IgM + IgG)
MONOCLONAL ANTIBODY
CLINICAL SIGNIFICANCE
First described in 1939, the RhD antigen is surpassed in importance only
by the antigens of the ABO blood group system. Transfusion of RhD posi-
tive blood to a RhD negative recipient or failure to administer prophylactic
anti-D to a RhD negative woman can result in the production of anti-D.
Consequently, establishing the correct RhD group is fundamental to safe
transfusion practice. Certain individuals exhibit a quantitative reduction in
the expression of their RhD antigen and are categorised as weak D (Du).
Others display a qualitative variation in RhD antigen expression and are
referred to as partial RhD. Weak D individuals may also be partial RhD.
REAGENT COMPOSITION
The main component of this reagent is derived from the in vitro culture
of the human/mouse heterohybridomas which secretes IgM anti-D and
another which secretes IgG anti-D. This is an anti -D blend
The clones used for the production of this reagent are mentioned on the
bottle.
SAFETY CAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in
vitro use.
• Refer to the current SDS available on request
or at www.biomaghreb.com;
• Verify the integrity of the reagents before use; and
• Disposal of waste: comply with the legislation in force.
For safety reasons, treat any specimen or reagent of biological origin as
potentially infectious.
Respect the legislation in force.
SAMPLE PREPARATION
Draw blood on anticoagulant.
Store blood that cannot be examined quickly (no hemolysis should be
observed) at +4°C.
PRESERVATION AND STABILITY
At + 4°C until the expiry date indicated on the label.
Preservative: Sodium Azide 1‰.
Strictly reserved for in vitro use.
PROCEDURE
1) On opaline plate
- Place 1 drop of reagent beside 1 drop of total blood (not washed).
- With adapted agitator mix on centrifuge spiral movement to form a
circular reaction with 2 cm in diameter.
- Rock several times the plate to homogenize the mixture.
- Read visually for 3 times.
2) In tube : Indirect coombs or LISS Coombs test:
- Wash 3 times the red cells in isotonic saline solution.
- Make a 3 - 5% cell suspension in isotonic saline solution or in low
isotonic strength solution(LISS).
- Into test tube mix 2 drops of reagent and 2 drops of cell suspension.
- Incubate at 37°C for 45 minutes (if isotonic saline solution is used) or
15 minutes (LISS).
- Wash 3 times in isotonic saline solution and dry the pellet of last was-
hing -
- Add 1 drop of polyvalent antiglobulin. (follow th antiglobulin procedure).
- Centrifuge at 500 g for 1 minute.
- Resuspend the cells gently.
- Read visually.
PARTICULAR ATTENTION
In indirect coombs ( standard or LISS) the albuminal monoclonal
anti-D reagent reacts with low D-samples).
For anti-Rhesus monoclonal albumin reagents, a negative albumin
control should be used in parallel. The absence of agglutination with
the control allows the specificity of a positive reaction with anti-D to be
confirmed.
SPECIAL PRECAUTION FOR USE
Humain origin product were found negative for HBs Ag and for antibo-
dies against HCV, HIV-1 and HIV-2 by approved test methods. However,-
since no test method can offer complete assurance that infectious agent
are absent, this product should be handled observing the same safety
precautions employed when handling any potentilly infectious material.
PERFORMANCE LIMITATIONS
The expression of some red cell antigens may decrease in strength during
storage, particularly in EDTA and coagulated samples. Better results will
be obtained with fresh samples.
Gently resuspend tube tests before reading. Excessive agitation may dis-
rupt the weak agglutination and produce false negative results.
Excessive centrifugation may result in difficulty resuspending the cell
button, while inadequate centrifugation may result in agglutinants that
disperse easily.
False positive or false negative results may occur due to contamination
of test materials, inadequate reaction temperature, improper storage of
materials, omission of test reagents, and certain disease states.
SPECIAL PRECAUTION FOR USE
Humain origin product were found negative for HBs Ag and for antibo-
dies against HCV, HIV-1 and HIV-2 by approved test methods. However,-
since no test method can offer complete assurance that infectious agent
are absent, this product should be handled observing the same safety
precautions employed when handling any potentilly infectious material.
SPECIFIC PERFORMANCE
CHARACTERISTICS
Prior to release, each batch of Anti-D is tested by the NBTC( National
Blood Transfusion Centre) .
FT En 39 Date of updating : 10/ 2020 Version B
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Harmful Sufcient
for < n > essais
Batch number
6, Rue Ibn Ennafis - Z.I. Lac 3 Tunisie
Tél. : 71 182 500 - Fax : 71 182 250
www.biomaghreb.com
IVD
IN VITRO DIAGNOSTIC USE
