5. Conclusions

This flow cytometry method is a sensitive and specific method that allows reproducible results. The concentration values are comparable with those estimated with other methods such as RIA and EIA used by commercial manufacturers of gamma globulins, and the method presents accuracy and precision. The test is completed in 3 h and is easy to perform, allowing quantitative assessment of Anti-D antibodies from plasma, fractions of the Cohn process, and finished products. The flow cytometry method presented shorter processing times (3 h) than the EIA or RIA methods (5 h).

The potential of the flow cytometry method described here represents an alternative to quantify Anti-D in different matrices and meets the criteria of good laboratory practices (simple, fast, and reliable as well as being sensitive and accurate). In the control of industrial processes, this method has shown reproducibility and reliability for this purpose.

The cost of materials is slightly lower for flow cytometry (\$ 15/test) than in EIA or RIA (\$ 25/test).

Flow Cytometry Assay for Quantitation of Therapeutical Anti-D IgG during Process Control… DOI: http://dx.doi.org/10.5772/intechopen.89614

Highly significant correlations were observed between the flow cytometry test Anti-D values and EIA values determined in different matrices (Serum, Fraction II, Semi-elaborated, gamma globulin).

For the case of process samples (Fraction II, semi-processed), strong correlations were observed between the flow cytometry test and the EIA values. A potential advantage of the flow cytometry assay could be the higher sensitivity presented than the EIA assay.

It is concluded that the flow cytometry method has advantages over the EIA and RIA method as a substitute for the present standard method.
