Evaluation of BioVue Column Agglutination Technology for quality control purpose of therapeutic anti-Rh immunoglobulin preparations

Abstract 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.