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Since 1996 CITM is a manufacturer of "in house" monoclonal reagents which are prepared from blood typing intermediates for further manufacturing use by Merck Millipore. The assortment includes reagents for ABO, RhD, Rh phenotype and Kell antigen blood grouping and very soon it will includes reagents for M, S, Jka, Jkb antigen typing also. It is essential that blood grouping reagents are prepared using reliable manufacturing procedures that are consistently capable of producing safe and efficacious products. The products must comply with requirements of the EU Directive (98/79/EC) on in vitro diagnostic (IVD) medical devices and other relevant international standards. These types of reagents according to the classification of Directive 98/79 / EC Annex II fall under List A, or in the IVD of high risk to the health of the individual. Therefore, all processes are running within the quality system ISO 9001:2008 and ISO 13485:2003, which is in the process of setting. Aim was to present the results of validation which is a part of the adjustment process of “in house” reagents on PK7300BC system. The validation was carried out according to the instructions amending Decision 2002/364 / EC on common technical specifications for in vitro diagnostic medical devices (2009/886 / EC) and the Guidelines for the blood transfusion services. By dilution, blending and chemical additions “in house” blood grouping regents are formulated for a variety of techniques including microaglutination technique for automatic system PK7300BC. Bromelain solution was prepared in 0, 1% concentration. 3129 ABO and RH1 (D) tests (2% "weak D") and 3199 Kell antigens and Rh phenotype (C, c, E, e) tests was carried out in parallel with the "in house" reagents and CE mark commercial reagents (Sifin), according to the CITM algorithm for testing blood donors. Routine work was simulated during validation. Discrepant results were confirmed by gel microcolumn assay (Bio-Rad) and by tube technique (Ortho-Clinical Diagnostics). The accuracy of the interpreted results of ABO and RH1 (D) blood group system and Kell antigen was 100%. The accuracy of Rh phenotype was 99.95% ; four discrepancies of C antigen are probably due to a technical problem, well contamination. In the next donations, results of C typing were correct. A weak types of D antigen: 1, 2, 3 and 14, are interpreted as D positive. Results of validation are more than satisfactory, especially if we consider the reasons for discrepant results for the C antigen using “in house” reagents. Interpretation of weak D types as RhD positive will reduce further testing of blood donors. The application of the "in house" blood grouping reagents on Beckman Coulter PK 7300 automated system for testing DDK proved to be very reliable. |
