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.

Evaluating automated titre score as an alternative to continuous flow analysis for the prediction of passive anti‐D in pregnancy

“…Manual titration methods, both tube and column agglutination indirect antiglobulin test (IAT), have been associated with inter‐laboratory variation due to the preparation of the reagents and serial dilutions, as well as the visual interpretation of the end result 12 . However, ORTHO BioVue Column Agglutination has been shown to be an appropriate replacement for tube IAT in antibody titration 13 by reducing some of the variability factors. Utilising an automated analyser to perform titration serial dilutions further improves standardisation and turnaround time and reduces the risk of errors associated with manual testing and interpretation 14 .…”