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1 0.8% Reagent Red Blood Cells (RRBCs) Abtectcell II 0.8%, Abtectcell III 0.8%, Abtectcell III 0.8% RhD Negative Screening Cells, Phenocell 0.8% and Revercell 0.8% 3. Abtectcell III 0.8% RhD Negative Screening Cells CSL Abtectcell III 0.8% RhD Negative Screening Cells are a three-cell Group O RhD Negative red cell panel for use in detecting unexpected alloantibodies other than anti-d. Consists of three 10mL vials of Group O RhD Negative human red cell suspensions. Contains one r r, one r r and one rr cell from individual donors. Complies with the ANZSBT Guidelines for Blood Grouping and Antibody Screening in As a minimum expresses: C, c, E, e, K, k, Fy a, Fy b, Jk a, Jk b, S, and where possible Kp a, M, N, x 5mL Product Specifications 1. Abtectcell II 0.8% CSL Abtectcell II 0.8% is a two-cell Group O red cell panel for use in detecting clinically relevant alloantibodies. Consists of two 10mL vials of Group O human red cell suspensions. Contains one or w cell and one cell from individual donors x 10mL. Abtectcell III 0.8% CSL Abtectcell III 0.8% is a three-cell Group O red cell panel for use in detecting clinically relevant alloantibodies. Consists of three 10mL vials of Group O human red cell suspensions. Contains one or w cell, one cell and one rr cell from individual donors x 10mL x (3 x 10mL) This document includes: Product Specifications Background Scientific Principles Validation Trial 4. Phenocell 0.8% CSL Phenocell (B Panel) 0.8% is an 11-cell Group O panel for use in identifi cation of clinically relevant alloantibodies. Consists of eleven 5mL vials of Group O human red cell suspensions. Contains three cells (at least one of which will be w ), two cells, one r r cell, one r r cell and rr cells from individual donors. Includes Phenocell Diluent for use in the preparation of autocontrol cell suspensions. Includes an RhD Negative Screening Cell Subset for patients with detectable levels of therapeutic anti-d x 5mL 5. Revercell 0.8% CSL Revercell 0.8% contains pooled human RhD Negative red cell suspensions for use in reverse or serum grouping to detect ABO blood grouping antibodies. Consists of two 10mL vials of multiple donor pooled human red cell suspensions comprising of one vial containing Group A 1 and one vial containing Group B cells. Designed for reverse (serum) ABO grouping x 10mL x ( x 10mL) CSL Bioplasma Immunohaematology P: F: E: ih@csl.com.au W:

2 Suitable Testing Platforms Column Agglutination Technology (CAT) Benefits of CSL's 0.8% RRBCs Fresh Manufactured using fresh red cells Universal Suitable for all testing platforms Quality Assured Proven performance, fi eld trialled and validated product Stable Confi rmed stability until expiry, consistent high level of sensitivity Reliable Developed and manufactured to CSL's strictest quality standards Dual Batches For a greater selection of antigens History CSL an Australian publicly owned company, employing Australians to develop and produce our reagents Ready to Use Barcoded, ready to use on the instrument Background CSL has for many years manufactured Abtectcell II and III Reagent Red Blood Cells (RRBCs) at a 3% concentration designed as suitable for use in tube antibody screening methods. In recent years, immunohaematology testing methods have changed signifi cantly with the advent and acceptance of Column Agglutination Technologies (CAT) and the subsequent migration from tile and tube techniques in many laboratories. CAT systems use glass or plastic beads in a plastic column to visualise agglutination reactions. The red cell concentration of these 3% products and the suspension diluent is not formulated for direct application in CAT systems. While CAT users may use the 3% cells in both Ortho BioVue and Diamed ID- MTS CAT methods, washing and dilution of the 3% cells in a dedicated low ionic strength diluent is required. Note: 3% suspensions may be used in the BioVue CAT platform. This additional dilution step is technically demanding and may be considered a potential source of error. CSL Bioplasma Immunohaematology has developed 0.8% reagent red blood cell suspension formulations of Abtectcell II, Abtectcell III, Revercell and Phenocell products. Suitable and validated for both the Ortho BioVue and DiaMed ID-MTS systems. Ready for direct addition into CAT systems after gentle mixing without washing or resuspension. Australian origin and are fresh, not frozen. Formulated from the same donor cells used for the 3% RRBC products produced concurrently. Abtectcell II 0.8%, Abtectcell III 0.8%, Abtectcell III 0.8% RhD Negative Screening Cells and Phenocell 0.8% contain CSL Celpresol LISS diluent and are designed to provide exceptional antibody screening specifi city and sensitivity. Revercell 0.8% contains CSL Celpresol diluent with EDTA to prevent haemolysis. Scientific Principles The tile or slide technique has been used for more than 100 years to detect agglutination reactions in immunohaematology testing. This technique generally uses red cells at concentrations between 15 and 50%. The tube technique came into common use in the 1950s and uses red cells at a 3% concentration. The newer CAT systems use chromatographic separation of agglutinated red cells to demonstrate a positive or negative reaction. These CAT systems use different cell concentrations and different cell/serum ratios, however the two commonly available systems allow the use of 0.8% RRBCs. The DiaMed CAT system employs the principle of centrifugation of red cells through a plastic gel containing specifi c reagents (eg. Anti-A, AHG, etc). Red cells and or serum/plasma are added to the reaction chamber of the microtube, incubated and then centrifuged. The gel traps agglutinates in or on top of the gel matrix, while unagglutinated red cells migrate to the bottom of the microtube. The BioVue CAT system uses a similar procedure but employs biphasic centrifugation through a glass microbead matrix to achieve the separation of non-agglutinated from agglutinated red cells. This system is able to use either traditional 3% or 0.8% red cell suspensions. CAT techniques have the advantage of a no-wash IAT procedure, stable reactions and are amenable to automation. They usually incorporate both the 37 C incubation phase and IAT in a single incubation/centrifugation step that is unable to differentiate between IgM and IgG antibodies. A number of reports have been published evaluating the CAT systems, and it is now widely accepted that both systems show similar performance and are no less sensitive than the conventional LISS Tube IAT. The 0.8% RRBC formulation means that the products are ready to use, require no dilution step and are suitable for Ortho BioVue and Diamed ID-MTS CAT users. The products have an excellent level of stability and diagnostic sensitivity and specifi city, which meets user requirements worldwide for antibody screening. [CSL's 0.8% RRBCs] are designed to provide exceptional antibody screening specificity and sensitivity.

3 0.8% RRBCs Validation Trial Celpresol LISS Validation Trial Design The CSL Validation Trial was designed to test the performance of the 0.8% RRBCs under routine conditions. The trial methodology was developed to analyse four specifi c product performance parameters: 1. Analytical sensitivity of Abtectcell 0.8% in BioVue and DiaMed ID-MTS compared to RRBC in routine use. This is defi ned as the ability to detect clinically relevant alloantibodies.. Specificity of Abtectcell II in BioVue and DiaMed ID- MTS compared to RRBC in routine use. This is defi ned as the ability not to detect clinically irrelevant alloantibodies. 3. Analyse reaction strengths recorded for clinically relevant antibodies detected comparing Abtectcell 0.8% in BioVue and ID-MTS compared to RRBC in routine use. This is to ensure the product has an appropriate level of discrimination between positive and negative samples. 4. Stability of the antigen expression and presentation on cells during the product shelf life. Additional detailed in-house stability testing was also performed to ensure consistency of analytical sensitivity during the stated product shelf life. Three batches of Abtectcell 0.8% were manufactured from three separate batches of Celpresol LISS. A batch of screening cells was also prepared using the same donor cells but using the previous LISS diluent as a control. Fifty sera containing clinically signifi cant alloantibodies were tested against all screening cells. CSL IH Development Laboratory tested all three batches of the product for detailed stability testing to ensure antigen stability and therefore consistent antibody detection during the shelf life of the product. Over two hundred negative sera were also evaluated to ensure that the required specifi city was obtained. Three batches were evaluated to provide a statistically valid sample and to measure both vial to vial and batch to batch variation. 1. Screening Cell Performance - Sensitivity The following alloantibodies were obtained from clinical samples and tested: Alloantibody Class Number Tested Rhesus 6 Kell 8 Duffy 9 Kidd 4 MNS 3 All alloantibodies were detectable across 3 different batches of Abtectcell in accordance with the validation study criteria, both initially and at expiration of the product, Comparison to Previous Diluent Initial performance compared to the control screening cells yielded the following results: Reaction compared to control BioVue DiaMed Weaker 0 0 Equal Stronger 3 Final performance at expiry compared to the control screening cells yielded the following results: Reaction compared to control BioVue DiaMed Weaker 0 1* Equal Stronger 6 * one example of anti-jk a gave a 5 in Celpresol LISS as compared to an 8 with the control screening cells. Note: Some samples were exhausted during the testing process. The results demonstrated that Celpresol LISS outperformed the previous diluent at both the inital timepoint and at timepoint beyond 10 weeks from the date of donation.. Screening Cell Performance - Specificity Samples with no detectable alloantibodies were tested and there were no incidences of any false positive results up until product expiry. Over 100 data points were generated across 3 different batches of product with no false positive results recorded. 3. Screening Cell Performance Reaction Strengths When initial and fi nal test scores were compared across the life of the product it was shown that whilst scores of 1 and 10 showed some slight variation, scores below were remarkably consistent: Score BioVue Number of antibodies Average score at reagent expiry

4 Score DiaMed ID-MTS Number of antibodies Average score at reagent expiry N/A Reactivity with alloantibodies included in the trial showed no signifi cant decrease in score across the period of the trial. 4. Red Cell Stability in Celpresol CSL has manufactured 3% RRBC products in Celpresol for a number of years. These products have a 10 week product life (post donation) and have been shown to deliver excellent stability over that time. 0.8% products diluted in this diluent (eg. Revercell 0.8%) show the same excellent stability (as would be expected due to their lower erythrocyte concentration). Red Cell Stability in Celpresol LISS During the validation trial cells were evaluated in Celpresol LISS and have been shown to be stable beyond expiry. These products have a 10 week product life (post donation) and have been shown to deliver excellent stability over that time. Cells were compared to those stored in Celpresol and in the previously used LISS diluent for CSL 0.8% RRBCs and showed no signifi cant haemolysis or bacterial contamination during this time. Conclusion CSL Abtectcell 0.8% was tested against a large range of clinically signifi cant alloantibodies encountered in clinical practice. The performance of Abtectcell 0.8% was evaluated in both Ortho BioVue and DiaMed ID-MTS systems. Abtectcell 0.8% detected all specifi cities of alloantibodies in accordance to ANZSBT Pretransfusion Testing Guidelines. CSL Abtectcell 0.8% performed well in both Ortho BioVue and DiaMed ID-MTS systems, and was found to have equivalent reaction strengths, sensitivity and specifi city to the previously used diluent, with the added benefi t of enhanced detection of clinically signifi cant antibodies. CSL 0.8% RRBCs were found to be very stable and to have very consistent performance during the 10 week shelf life (post donation) of the product. Precautions The material from which this product was derived was found to be non-reactive for specifi ed markers for HIV 1 and, Hepatitis B and C, HTLV and Syphilis by currently approved methods. However no known method can assure that products derived from human blood will not transmit infectious agents. However good laboratory practice requires safe handling procedures. Abtectcell II 0.8%, Abtectcell III 0.8%, Abtectcell III 0.8% RhD Negative Screening Cells and Phenocell 0.8% contain Trimethoprim and Sulfamethoxazole to retard bacterial contamination. Revercell 0.8% contains Neomycin Sulphate and Chloramphenicol as antibacterial agents and Thiomersal (0.001% w/v) as a preservative. Users should take appropriate precautions when handling and discarding these reagents. For in vitro diagnostic use only. Incorrect reactions may occur due to: 1. Failure to comply with the recommended procedures.. Variations in time and temperature of incubation, centrifuge speeds and reaction reading methods. 3. Contamination of test samples, reagents or supplementary materials. 4. Use of aged or expired samples or reagents. 5. Incorrect red blood cell suspension strengths. Storage and Handling Store at to 8 C (Do Not Freeze) Refrigerated to 8 C when not in use Take appropriate precautions to maintain sterility Do not use if: Subjected to prolonged periods of high temperature Signs of gross haemolysis are present in red cell suspensions Expiration date has passed 0.8% RRBCs do not need to be washed or diluted and are ready for use after gentle mixing to resuspend the cells Antibody Screening and Identification Blood samples should be withdrawn by aseptic technique. Serum or EDTA plasma may be used. Serum should be separated from the clot as soon as possible and stored at -0 C if testing is delayed. Note: the use of stored serum or EDTA plasma may result in failure to detect complement-dependent antibodies. Please refer to the Column Agglutination Technology manufacturer s recommended sample collection requirements. Reverse or Serum Grouping Blood samples should be withdrawn by aseptic technique, with or without the addition of anticoagulants. Tests should be performed as soon as possible after collection of the sample. If testing of the blood samples is delayed, samples should be stored between to 8 C. Serum or plasma may be used for reverse ABO Grouping, and should preferably be less than four days old when tested, although samples up to three weeks of age give satisfactory results. Please refer to the Column Agglutination Technology manufacturer s recommended sample collection requirements 4

5 References 1. Race R, Sanger A. Blood groups in man. 6 th Ed. Oxford: Blackwell Scientifi c Publications 1975, Chapter.. Issitt, PD. Applied Blood Group Serology. 3 rd Ed. Montgomery Scientifi c. Miami, Daniels G. Human Blood Groups. nd Ed. Blackwell Science. Carlton, Victoria Green R, et al. Basic Blood Grouping Techniques and Procedures. nd Ed. Victorian Immunohaematology Discussion Group Australian and New Zealand Society of Blood Transfusion Inc. Guidelines for Pretransfusion Laboratory Practice. 5 th Ed Lapierre Y, Rigal D, Adam J. The gel test: A new way to detect red cell antigen antibody reactions. Transfusion 1990; 30: Malyaka H,Weiland D. The gel test Laboratory Medicine 1994; 5: Harmening DM. Modern Blood Banking and Transfusion Practices. 5 th Ed. FA Davis Company. Philadelphia Roback, JD, et al. Ed. American Association of Blood Banks Technical Manual. 16 th Ed. Bethesda, Maryland Weisbach V, Ziener A, Zimmermann R, Glaser A, Zingsem J, Eckstein R. Comparison of the performance of four microtubule column agglutination systems in the detection of red cell alloantibodies. Transfusion 1999; 39: Eichler H, Bohler A, Hastka J, Richter E, Kerowgan M, Goldmann SF. Micro -column affi nity test and gel test: Comparative study of two techniques for red cell antibody screening. Vox Sanguinis 1999; 77: Allen JC, Bruce M, Mitchell R. The preservation of red cell antigens at low ionic strength. Transfusion 1990; 30: DiaMed CAT method, please refer to the DiaMed ID-MTS ID- Card LISS/Coombs and DiaClon ABO/D + Reverse Grouping or appropriate product leafl ets. 14. BioVue CAT method, please refer to the Ortho BioVue Poly Cassette and ABO-Rh/Reverse Grouping Cassette or appropriate product leafl ets. LAST REVISED OCTOBER 08 No expressed, implied or contingent liability is assumed for product use or patent infringements. Products detailed are for purposes described within the product leaflet only. All information contained is copyright CSL Limited. 5 CSL Bioplasma Immunohaematology P: F: E: ih@csl.com.au W: