The antigens require the presence of disulphide bonds for full Monoclonal antibodies exhibit a high degree of potency, 2. Add 2 drops of blood grouping reagent to a glass test tube. expression and are destroyed by treatment with trypsin and avidity and specificity. When using such antibodies, great 3. Add 2 drops of red blood cell suspension. chymotrypsin in combination. care should be taken to avoid cross contamination. 4. Mix the contents of the test tube and incubate at 20°C for 5 minutes. Kell system antibodies are capable of causing haemolytic This product has components (dropper bulbs) containing 5. Centrifuge the test tube. transfusion reactions and haemolytic disease of the newborn and dry natural rubber. 6. NOTE: Suggested centrifugation: 900-1000g are optimally detected by the indirect antiglobulin technique. (approx. 3400 rpm) for 10 seconds or a time and speed BLOOD GROUPING REAGENT SPECIMEN COLLECTION AND PREPARATION appropriate for the centrifuge used that produces the PRINCIPLE OF THE TEST Specimens should be collected by a standard collection strongest reaction of antibody with antigen-positive red Anti-k (cellano) When used by the recommended technique, this reagent will technique. The specimen should be tested as soon as blood cells, yet allows easy re-suspension of antigen- ALBAclone® cause the agglutination (clumping) of red blood cells carrying the possible after collection. If testing is delayed, the specimen negative red blood cells. k (cellano) antigen. Lack of agglutination demonstrates the should be stored at refrigerated temperatures. 7. After centrifugation, gently shake the tube to dislodge the (Mouse Monoclonal/Direct Agglutinin) absence of the k (cellano) antigen. cell button from the bottom and immediately observe Tube Technique: macroscopically for agglutination. For Tube and BioVue® Technique REAGENT DESCRIPTION Clotted samples, or those collected in EDTA, should be 8. Record results. The main component of this reagent is derived from the in vitro tested within seven days from collection. Donor blood culture of the immunoglobulin secreting mouse hybridoma Lk1: collected in citrate anticoagulant may be tested until the ORTHO BioVue® - Neutral Cassette, Immediate Spin expiration date of the donation. 1. Prepare a 0.8% or 3-5% red cell suspension from patient Z137 Product Name Product Code Cell Line or donor cells, using isotonic saline. Anti-k Z137 Lk1 BioVue® CAT Technique: 2. Allow the cassette and reagent to come to 21-25°C prior Clotted samples, or those collected in EDTA, should be to use. INTERPRETATION OF LABELLING SYMBOLS The formulation consists of culture supernatant containing tested within fourteen days from collection. Donor blood 3. Label the cassette appropriately with a sample identifier. bovine material, potentiators, EDTA and <0.1% (w/v) sodium collected in ACD, CPD, CPDA -1, CP2D, CP2D with AS-3, 4. Add 40µL of the blood grouping reagent to the azide buffered to pH 5.2. CPD with AS-1, and CPD with AS-5 may be tested until the appropriate reaction chamber(s) of the opened Batch code expiration date of the donation. cassette. Do not touch the pipette to the side of the NOTE: The volume delivered by the reagent dropper bottle is reaction chamber. If this occurs, change pipette tip Use by (YYYY-MM-DD) approximately 40µL. Care should be taken to ensure that Special care should be taken if haemolysed samples must be before proceeding to the next chamber. appropriate serum to cell ratios are maintained in all test tested. Grossly icteric or contaminated blood specimens 5. Add 50µL of 0.8% red cell suspension or add 10µL of 3- should not be used. Product Code systems. 5% red cell suspension to the appropriate reaction chamber(s) of the cassette. This reagent complies with the requirements of Directive MATERIALS 6. Observe that the contents of the reaction chamber(s) are Storage temperature limitation (2-8 °C) 98/79/EC on in vitro Diagnostic Medical Devices and the combined. If necessary tap gently. recommendations contained in the Guidelines for Blood Material provided NOTE: Assure that the reagents remain in the reaction Transfusion Services in the United Kingdom. • ALBAclone® Anti-k (cellano) chamber. There should be no mixing of reactants with In vitro diagnostic medical device reagents in the column prior to centrifugation. Materials required but not provided (dependant on STORAGE CONDITIONS 7. Immediately centrifuge the cassette using the ORTHO technique) The reagent should be stored at 2-8 °C. BioVue® System Centrifuge. Consult instructions for use • PBS pH 7.0 ± 0.2 or isotonic saline 8. Read the front and back of the individual columns for PRECAUTIONS FOR USE AND DISPOSAL agglutination and/or haemolysis upon test completion. • Pipettes For in vitro diagnostic use only 9. Record the reaction strength. • Reagent red cells suitable for the control of Anti-k Products should be used by qualified personnel • 10 x 75 mm or 12 x 75 mm glass test tubes Manufacturer Does not use beyond the expiration date Do not use if turbid The use of this reagent on ORTHO VISION™ Analyzer and Do not dilute • Centrifuge ORTHO VISION™ Max Analyzer requires use of a User Defined • Timer Reagent within the analyser software. For instructions on how to The format of the expiration date is expressed as YYYY-MM- • ORTHO BioVue® Neutral Cassettes configure the analyser to use ALBAclone® Anti-k (Z137) please INTENDED USE DD (Year-Month-Day) • ORTHO BioVue® Workstation/Centrifuge refer to the following User Guide/s. ORTHO VISION™ Analyzer The Anti-k reagent is for the in vitro detection and identification • ORTHO VISION™/VISION™ MAX Analyzer ORTHO BioVue® Cassettes User Defined Protocols (UDP) & of the k antigen on human red blood cells by direct This reagent contains <0.1% (w/v) sodium azide. Sodium azide • ORTHO Optix™ Reader User Defined Reagents (UDR) Guide and ORTHO VISION™ agglutination. may react with lead and copper plumbing to form explosive • Cassette Rack MAX Analyzer ORTHO BioVue® Cassettes User Defined compounds. If discarded into a sink, flush with a large volume Protocols (UDP) & User Defined Reagents (UDR) Guide. of water to prevent azide build-up. PROCEDURES SUMMARY AND EXPLANATION Harmful to aquatic life with long lasting effects. Avoid release to This reagent has been standardised for use by the STABILITY OF REACTION Since the description of the antigen K in 1946 by Coombs the environment. Dispose of contents/container in accordance techniques described below and therefore its suitability for Test results should be read, et al and its allele k in 1949 by Levine et al, the Kell blood with local/regional/national/international regulations. use in other techniques cannot be guaranteed. When a interpreted and recorded group system has been shown to be increasingly complex test is required to be incubated for a specific time period, immediately after centrifugation. and over 20 antigens are now known to be associated with This reagent is of animal origin, therefore care must be taken a timer should be used. Delays may cause dissociation of the system. These are probably controlled from a series of during use and disposal as there is a potential infection risk. antigen-antibody complexes closely linked loci so that Kell antigens, like CDE in the Rh When using supplemental testing equipment (i.e. resulting in weak positive or false system, are inherited as a haplotype. CAUTION: SOURCE MATERIAL FROM WHICH THIS centrifuge), follow the procedures that are contained in the negative reactions. PRODUCT WAS DERIVED WAS FOUND NEGATIVE FOR operator’s manual provided by the device manufacturer. The antigens of the Kell blood group system are of further INFECTIOUS AGENTS. INTERPRETATION OF RESULTS interest in that they tend to occur either very frequently (eg k Tube Technique - NIS 5 Min Incubation/Spin Agglutination = positive test result 99.8%) or relatively infrequently (eg K 8%) and show This reagent is of animal origin (murine and bovine), therefore 1. Prepare a 2-3% suspension of red blood cells in PBS pH No agglutination = negative test result considerable ethnic variation e.g. the antigen Jsa is extremely care must be taken during use and disposal as there is a 7.0 ± 0.2. (Reagent Red Blood Cells may be used directly rare in whites but is expressed by 20% of black Americans. potential infection risk. from the vial or according to manufacturer’s instructions). Interpretation of ORTHO BioVue test results should be BioVue® Cassettes User Defined Protocols (UDP) & BRUGSANVISNING Ο γραμμικός κωδικός παρέχεται παρακάτω για σκοπούς performed as directed by ORTHO BioVue® System User Defined Reagents (UDR) Guide Du kan finde en brugsanvisning på Quotients websted på σάρωσης. Cassettes Interpretation Guide (J39791 EN), Ortho Clinical 6. ORTHO™ BioVue® System Cassette Interpretation www.quotientbd.com, eller den kan fås på anmodning fra din Παρακαλούμε σημειώστε ότι ο γραμμικός κωδικός που Diagnostics. Guide (J39791EN), Ortho Clinical Diagnostics lokale distributør ved at oplyse den relevante produktkode på ακολουθεί είναι ειδικός για κάθε παρτίδα (ο αριθμός produktmærkaterne og den brugsanvisning, der fulgte med παρτίδας εμφανίζεται αμέσως κάτω από τον γραμμικό QUALITY CONTROL produktet. κωδικό) - αυτές οι οδηγίες χρήσης θα πρέπει να φυλαχθούν Quality control of reagents is essential and should be DATE OF ISSUE μαζί με το φιαλίδιο του προϊόντος με το οποίο performed on the day of use. 2021-01-15 GEBRUIKSAANWIJZING παρασχέθηκαν. De gebruiksaanwijzing staat op de Quotient-website K+k+ red blood cells should be used as a positive control. Quotient Suisse S.A. (www.quotientbd.com) of kan bij uw leverancier worden A continuación encontrará el código de barras lineal para su K+k- red blood cells should be used as a negative control. Unit B1 Terre Bonne Business Park aangevraagd door de desbetreffende productcode te lectura. Route de Crassier 13 vermelden. Deze code staat op productlabels en in de Tenga en cuenta que el siguiente código de barras es PERFORMANCE LIMITATIONS Eysins 1262, Switzerland gebruiksaanwijzing die bij het product worden geleverd.