Is HemoGenix Assay HALO 96 PCAEQ Really CFU-Equivalent Progenitor Cell Assay?

• Activity Number: 693
• Type: Contributed
• Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Pingfu Fu* and Jane Reese and Brittney Hooper
• Companies: Case Western Reserve University and Case Western Reserve University and Case Western Reserve University
• Keywords: HemoGenix assay ; CFC assay ; equivalence ; Deming and Passing Bablok regressions ; Pearson correlation ; measurement error

Abstract

Colony-forming cell (CFC) assay is an in vitro assay used in the study of hematopoietic stem cells. HemoGenix is Adenosine TrihosPhate (ATP)-based, in vitro bioluminescence and cell-based assay. Both assays measure the ability of hematopoietic progenitor's proliferation and differentiation. The objective of the study is to investigate if the two assays are equivalent. Both assays were applied to cell samples from 6 donors and 10 cancer patients. ATPs and Colony-forming units (CFUs) were obtained. Both Deming and Passing Bablok regressions along with Pearson correlation coefficient were used to evaluate the equivalence and association of two assays. The results from both regression models (ATP = ?+?*CFU+ ?) were ? = -0.347 (95% CI: -0.489, -0.205) (Deming) and ? = -0.32 (95% CI: -0.42, -0.18) (Passing Bablok), and ? = 0.0078 (95% CI: 0.007, 0.009) (Deming) and ? = 0.0076 (95% CI: 0.006, 0.008) (Passing Bablok). The results demonstrate that the two assays were not equivalent as intercept is significantly from 0 and slope is significantly from 1, although there was a strong positive association between the two assays with Pearson correlation coefficient of 0.97 (p < 0.0001).