DIALAB Produktion und Vertrieb von chemisch – technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

A – 2351 Wiener Neudorf, Austria, IZ-NÖ Süd, Hondastrasse, Objekt M55

LIMITATIONS
Anti-H Lectin 1. Dialab Anti-H Lectin may react with test red cells that are Tn-
polyagglutinable or Cad-positive.
For Tube Techniques. 2. Stored blood may give weaker reactions than fresh blood.
3. False positive or false negative results may also occur due to:
• Contamination of test materials
B09934 1x 2 mL Anti-H Lectin • Improper storage, cell concentration, incubation time or
temperature
For professional in vitro diagnostic use only. • Improper or excessive centrifugation
SUMMARY • Deviation from the recommended techniques
The H antigen is part of the Hh system and is found on all red cells except PERFORMANCE CHARACTERISTICS
those of Oh (hh) Bombay phenotype, which is extremely rare. 1. The reagent has been characterised by all the procedures mentioned
Anti-H Phenotype Prevalence % in the Recommended Technique.
2. Prior to release, each lot of Dialab Anti-H Lectin reagent is tested by
+ H+ 99.9% the Recommended Techniques against a panel of antigen-positive
0 H- Very rare red cells to ensure suitable reactivity.
3. Dialab Anti-H has been formulated to be non-reactive with most A1
H is the precursor of A and B and so group A and B people have less H than
and A1B red cells and reactive with A2 red cells.
O people. The order of reactivity of Anti-H with red cells of various ABO
4. The Quality Control of the reagent was performed using red cells that
groups is:
had been washed twice with PBS prior to use.
Strong --------------------------------------------------------------------------- Very weak 1. The reagent complies with the recommendations contained in the
O A2 B A2B A1 A1B latest issue of the Guidelines for the UK Blood Transfusion Services.
DISCLAIMER
TEST PRINCIPLE 1. The user is responsible for the performance of the reagents by any
The reagent will cause agglutination (clumping) of test red cells that carry method other than those mentioned in the RECOMMENDED
the H antigen, after centrifugation. No agglutination generally indicates the TECHNIQUES.
absence of the H antigen (see Limitations). 2. Any deviations from the RECOMMENDED TECHNIQUES should be
validated prior to use.
REAGENTS
Dialab Anti-H Lectin blood grouping reagent is prepared from an extract of PRECAUTIONS
Ulex europaeus seeds, diluted with a sodium chloride solution containing 1. The reagent is intended for in vitro diagnostic use only.
bovine albumin. The reagent is supplied at optimal dilution for use with all 2. If a reagent vial is cracked or leaking, discard the contents
recommended techniques stated below without the need for further dilution immediately.
or addition. For lot reference number and expiry date see Vial Label. 3. Do not use the reagent past the expiration date (see Vial Label).
4. Do not use the reagent if a precipitate is present.
STORAGE
5. Protective clothing should be worn when handling the reagents, such
The reagent vials should be stored at 2 - 8ºC on receipt. Prolonged storage as disposable gloves and a laboratory coat.
at temperatures outside this range may result in accelerated loss of reagent 6. The reagent has been filtered through a 0.2 µm capsule to reduce the
reactivity. Reagent will remain stable for up to 7 days when subjected to bio-burden. Once a vial has been opened the contents should remain
temperatures not exceeding 30ºC. viable up until the expiry date as long as there is no marked turbidity,
SAMPLE COLLECTION AND PREPARATION which can indicate reagent deterioration or contamination.
7. The reagent contains < 0.1% sodium azide. Sodium azide may be
Blood samples drawn with or without anticoagulant may be used for antigen toxic if ingested and may react with lead and copper plumbing to form
typing. If testing is delayed, then store specimens at 2-8ºC. EDTA and explosive metal azides. On disposal flush away with large volumes of
citrate samples should be typed as soon as possible. Samples collected into water.
ACD, CPD or CPDA-1 may be tested up to 35 days from the date of 8. No known tests can guarantee that products derived from human or
withdrawal. All blood samples should be washed at least twice with PBS animal sources are free from infectious agents. Care must be taken in
before being tested. the use and disposal of each vial and its contents.
CONTROLS AND ADVICE DISPOSAL OF REAGENTS AND DEALING WITH SPILLAGES
1. It is recommended known A2 and A1 control red cells be tested in For information on disposal of the reagent and decontamination of a spillage
parallel with each batch of tests. Tests must be considered invalid if site see Material Safety Data Sheets, available on request.
controls do not show expected results.
2. In the Tube Technique one volume is approximately 50µl when using LITERATURE
the vial dropper provided. 1. Widman FK. Technical Manual, 9th Edition. American Association of
3. Use of the reagent and the interpretation of results must be carried out Blood Banks, Arlington, VA, 1985; Chapter 8
by properly trained and qualified personnel in accordance with 2. Race RR, Sanger R. Blood Groups in Man, 6th Edition. Blackwell
requirements of the country where the reagent is in use. Scientific, Oxford 1975; Chapter 2
4. The user must the determine suitability of the reagent for use in other 3. Mollison PL. Blood Transfusion in Clinical Medicine, 8th Edition.
techniques. Blackwell Scientific, Oxford 1987; Chapter 7
REAGENTS AND MATERIALS REQUIRED 4. Issitt PD. Applied Blood Group Serology, 3rd Edition. Montgomery
Scientific, Miami 1985; Chapter 6
• Glass test tubes (10 x 75 mm or 12 x 75 mm) 5. Guidelines for the Blood Transfusion Service in the United Kingdom.
• Known group A2 and A1 control red cells H.M.S.O. Current Edition.
• Phosphate Buffered Saline (PBS): NaCl 0.9%, pH 7.0 ± 0.2 at 22ºC ± 6. British Committee for Standards in Haematology, Blood Transfusion
1°C Task Force. Recommendations for evaluation, validation and
• Test tube centrifuge implementation of new techniques for blood grouping, antibody
• Volumetric pipettes screening and cross matching. Transfusion Medicine, 1995, 5, 145-
150
RECOMMENDED TECHNIQUE
Tube Technique
1. Prepare a 2-3% suspension of washed test red cells in PBS.
2. Place in a labelled test tube: 1 volume of Dialab Anti-H reagent and 1
volume of test red cell suspension.
3. Mix thoroughly and incubate at room temperature for 5 minutes.
4. Centrifuge all tubes for 20 seconds at 1000 rcf or for a suitable
alternative time and force.
5. Gently resuspend red cell button and read macroscopically for
agglutination.
INTERPRETATION OF TEST RESULTS
1. Positive: Agglutination of the test red cells constitutes a positive test
result and within accepted limitations of test procedure, indicates the
presence of the H antigen on the test red cells.
2. Negative: No agglutination of the test red cells constitutes a negative DIALAB Produktion und Vertrieb von chemisch – technischen
result and within the accepted limitations of the test procedure, Produkten und Laborinstrumenten Gesellschaft m.b.H.
indicates the absence of the H antigen on the test red cells. A – 2351 Wiener Neudorf, Austria
STABILITY OF THE REAGENTS IZ-NÖ Süd, Hondastrasse, Objekt M55
Phone: ++43 (0) 2236 660910-0
1. Tests should be read immediately after centrifugation. Delays may Fax: ++43 (0) 2236 660910-30 e-mail: [email protected]
result in dissociation of antigen-antibody complexes leading to false
negative or weak positive reactions.
2. Caution should be exercised in the interpretation of results of tests
performed at temperatures other than those recommended.
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