بررسی فناوری BioVue ستون آگلوتیناسیون برای کنترل کیفیت هدف از آماده سازی ایمونوگلوبولین ضد Rh درمانی

The preparation anti-D immunoglobulin is an important therapy for both treatment and protection. Titer of anti-D immunoglobulin preparation is an important factor to determine the dose of treatment. Many methods are used to evaluate the titer of anti-D immunoglobulin preparation. One of the new methods developed recently is column agglutination test. To evaluate the BioVue column agglutination test, it was compared to conventional tube agglutination test using anti-D immunoglobulin preparations from three different producers, ten lots each. Results showed that the BioVue column agglutination test is comparable to conventional tube agglutination test but with much ease. In conclusion, the BioVue column agglutination test is accurate and easy to use in determination of anti-D titer for quality control purposes.

Human Anti-Rh(D) immunoglobulin (anti-D) is a liquid or freeze-dried preparation containing immunoglobulin, mainly immunoglobulin G. The preparation is intended for intramuscular administration. It contains specific antibodies against erythrocyte D-antigen and may also contain small quantities of other blood-group antibodies. Human anti-D immunoglobulin is preferably obtained from the plasma of donors with a sufficient titer of previously acquired anti-D antibodies (Ph Eur, 2009). Although anti-Rh(D) was once the major etiology of haemolytic disease of the fetus and newborn (HDFN), the widespread adoption of antenatal and postnatal anti-D immunoglobulin has resulted in a marked decrease in the prevalence of alloimmunization due to the Rh(D) antigen present during pregnancy (Singla et al., 2010). Immune thrombocytopenia (ITP) is an acquired bleeding autoimmune disorder characterized by a markedly decreased blood platelet count. Anti-D has been successfully used in the setting of both acute and chronic immune thrombocytopenia (Cheung and Liebman, 2009). Preventing alloimmunization to the D antigen in other individuals would allow for the transfusion of D+ blood in an emergency, continued support with D+ granulocyte concentrates, and possibly prevent the concomitant formation of autoantibody (Rosse et al., 1990). Titration is the common and simple method used in the routine laboratory to estimate the titer of an antibody (Judd, 2001). Anti-D immunoglobulin titration can be performed in tubes, microplates or using microcolumn tests. Coombs et al. (1945) described the indirect antiglobulin test (IAT), and Diamond and Abelson (1945) described albumin, as a potentiator for the detection of “incomplete” or IgG antibodies. This classic saline IAT is still viewed as the gold standard (Rumsey and Ciesielski, 2000). Three types of microcolumn tests have been developed: BioVue Column Agglutination Technology, affinity columns and glass microcapsules (Lapierre et al., 1990 and Walker, 1997). The BioVue Column Agglutination Technology assay has been widely used in blood banking in Europe and America since 1991 for direct and indirect antiglobulin tests, ABO/Rh typing, red blood cell phenotyping, detecting unexpected antibodies, and for other applications (Lapierre et al., 1990). Its popularity grew from its standardized performance, technical ease, stable endpoint and the versatility of the methodology. The purpose of the current study was to evaluate BioVue Column Agglutination Technology microcolumn assay for anti-D immunoglobulin titration in National Control Laboratories. The use of such method will facilitate the process of evaluating anti-D Ig titer in shorter time with more accurate results.

The advantages of the BioVue Column Agglutination Technology test include small sample size, decreased variation in volume delivery, greater uniformity between repeat tests, no cell washing step, and decreased technique dependence. The BioVue Column Agglutination Technology test has relatively few steps in the procedure and it provides a clear, easy-to-read, stable endpoint, so it is easy to learn. When the microtubes are covered and refrigerated, the BioVue Column Agglutination Technology cards can be read with accuracy for at least 24 h after testing. Sensitivity and specificity of BioVue Column Agglutination Technology testing have been found to be comparable to the tube agglutination test. The BioVue Column Agglutination Technology test method can replace tube agglutination method and other methods proposed in Ph Eur (2009) to evaluate the concentration of human anti-D immunoglobulin in national control laboratories as well as producer quality control laboratories.