FT En 37 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
ANTI-AB
MONOCLONAL ANTIBODY
CLINICAL SIGNIFICANCE
ABO blood grouping is generally performed by testing red blood cells with
anti-A and anti-B.
In order to generate confirmatory blood group information and exclude
misgrouping of weak A variants as group O, e.g. Ax, many laboratories
also test with anti-A,B.
Reverse or serum grouping of the patient’s serum by testing with A1 red
blood cells and B red blood cells should be performed to provide a further
check of the accuracy of observed ABO blood grouping results.
Monoclonal antibodies exhibit a high degree of potency, avidity and spe-
cificity. When using such antibodies, great care should be taken to avoid
cross contamination
REAGENT COMPOSITION
The main component of this reagent is derived from the in vitro culture of
the monoclonal immunoglobulin secreting mouse hybridoma.
The reference of the clones used are mentioned on the label of 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 preferably on anticoagulant.
On dry tube, dissociate the clot well.
Store blood that cannot be examined quickly at +4°C (no hemolysis should
be observed).
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
• No washed Total Blood.
- Place 2 drops of reagent and 1 drop of unwashed blood side by side;
- Mix with a stirrer using a centrifugal spiral motion to form a circular reac-
tion 2 cm in diameter ;
- Rock the plate several times to homogenize the mixture;
- Read visually for 3 minutes.
• No washed Red blood cells in suspension at 10 % in isotonic saline
- Place 2 drops of the reagent and 2 drops of the red blood cell suspension
(unwashed) side by side in 10% physiological water;
- Mix with a stirrer using a centrifugal spiral motion to form a circular reac-
tion of 2 cm in diameter;
- Rock the plate several times to homogenize the mixture;
- Read with the naked eye after 3 minutes.
2) In tube.
- Wash 3 times the red blood cells in physiological water;
- Prepare a suspension of red blood cells at 5% in physiological water ;
- Mix 2 drops of the reagent and 2 drops of the red blood cell suspension
in a tube;
- Centrifuge 1 minute at 500 g ;
- Resuspend red blood cells by gently shaking the tubes;
- Read visually.
PARTICULAR ATTENTION
Anti-AB reagent visibly agglutinates red blood cells Ax.
PERFORMANCE LIMITATIONS
ABO antigens are not fully expressed at birth and, therefore, tests involving
cord/neonatal red blood cells should be interpreted with particular care.
In the case of any discrepancy between the blood and serum tests, all ne-
gative opaline plate tests should be confirmed by tube tests to confirm the
absence of weak subgroups..
Gently resuspend tube tests before reading. Excessive agitation may dis-
rupt weak agglutination and produce false negative results.
Excessive centrifugation can lead to difficulty in resuspending the cell
button, while inadequate centrifugation may result in agglutinates that are
easily dispersed.
The expression of certain red blood cell antigens may diminish in strength
during storage, particularly in EDTA and clotted samples. Better results will
be obtained with fresh samples.
False positive or false negative results can occur due to contamination of
test materials, improper reaction temperature, improper storage of mate-
rials, omission of test reagents and certain disease states.
QUALITY CONTROL
Quality control of reagents is essential and should be performed on the
day of use and in accordance with national regulations. For ABO blood
grouping reagents, appropriate antigen positive and negative red blood
cells should be used.
SPECIFIC PERFORMANCE
CHARACTERISTICS
Prior to release, each batch of Anti-A is tested by NBTC ( National Blood
Transfusion Centre) .
IVD
IN VITRO DIAGNOSTIC USE
