) of linear regression above 0.99 and matrix effects nearly negligible for both methods. The specificity, precision and accuracy of these methods were proven in the analysis of six determinations per operator in three different series. Altogether, these results indicate a good accuracy and precision of the proposed methods determining absolute counts, viability, and proportions of live CD34/CD45+ cells and accessory populations. This validated flow cytometry assay will be implemented for release testing in the forthcoming Phase III clinical trial of ProtheraCytes in post-AMI patients.
Bouis et al. (Sun,) studied this question.