Method comparison study of peripheral blood CD34+ count performed on an Abbott CELL‐DYN Sapphire hematology analyzer versus flow cytometry reference procedure (modified ISHAGE). Issue 2 (13th August 2018)

• Record Type: Journal Article
• Authors: Avecilla, Scott T.; Goss, Cheryl; Marionneaux, Steven M.; Wright, Donald R.; Leiva, Tyler D.; Tonon, Jo‐ann; Smith, Katherine M.; Maslak, Peter
• Is Part Of: Advances in cell and gene therapy. Volume 1:Issue 2(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2018-08-13
• Subjects: CD34+ count -- CELL DYN Sapphire -- HPC(A) -- ISHAGE analysis -- stem cell harvest; Cellular therapy -- Periodicals; Gene therapy -- Periodicals; Immunotherapy -- Periodicals; Cancer -- Treatment -- Periodicals; Bone marrow -- Diseases -- Treatment -- Periodicals; Blood -- Diseases -- Treatment -- Periodicals; 615.5
• DOI: 10.1002/acg2.15
• Languages: English
• ISSNs: 2573-8461

Abstract

Abstract: CD34 + cell enumeration is a critical parameter used to determine the timing of apheresis collections of hematopoietic progenitor cell products (HPC(A)). Automated hematology analyzers equipped with flow cytometry capabilities may be a solution to the problem of limited access to standard flow cytometry testing. We compared CD34 + cell enumeration using a reference flow cytometry procedure employing modified International Society of Hematotherapy and Graft Engineering (ISHAGE) analysis with a hematology analyzer/flow cytometer hybrid (CELL DYN (CD)Sapphire) using a sequential gating analysis designed to emulate the ISHAGE gating strategy. CD34 + cell values obtained from the ISHAGE and CD Sapphire analysis was plotted and compared in a linear regression analysis which showed a high degree of correlation ( R 2 = 0.96). No statistically significant ( P = 0.53) differences in CD34 + cell enumeration values were observed between the flow cytometer and automated hematology analyzer using manual analysis schema. We have demonstrated that an automated hematology analyzer equipped with a flow module can provide CD34 + cell enumeration results in the peripheral blood for clinical decision algorithms without the need for a dedicated flow cytometry laboratory.