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Ann Lab Med. 2019 Jul;39(4):388-395. English. Original Article. https://doi.org/10.3343/alm.2019.39.4.388
Yu H , Yoo J , Hwang JS , Kim M , Bae KH , Jekarl DW , Oh JH , Lee JY , Han S , Chung C , Kim M , Kim Y .
Laboratory Development and Evaluation Center, College of Medicine, The Catholic University of Korea, Seoul, Korea. yonggoo@catholic.ac.kr, microkim@catholic.ac.kr
Department of Biomedicine & Health Sciences, Graduate School, The Catholic University of Korea, Seoul, Korea.
Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
NanoEntek, Seoul, Korea.
Abstract

Background

It is very important to accurately enumerate CD34-positive (CD34+) cells for successful hematopoietic stem cell transplantation (HSCT). We evaluated the ability of the newly developed image based-immunofluorescence cell counter ADAMII (NanoEntek, Seoul, Korea) to enumerate CD34+ cells, which was improved through simultaneous CD45 analysis.

Methods

We enumerated CD34+ cells with ADAMII using 19 peripheral blood (PB) and 91 leukapheresis samples from HSCT donors. Analytical performance, including precision and linearity, was analyzed, and sample stability during storage was evaluated. Viable CD34+ cell count (vCD34) and viable CD45+ cell count (vCD45) and the percentage of viable CD34+ cells among viable CD45+ cells (CD34/CD45) as measured by ADAMII were compared with the corresponding values from two flow cytometry assays, using regression analysis.

Results

ADAMII demonstrated acceptable precision, as CV values of vCD34 from six samples with different counts were all < 10% (range: 3.49–9.51%). CV values of the vCD45 and CD34/45 ranged from 4.03% to 9.67% and from 2.48% to 10.07%, respectively. The linearity of vCD34 showed an excellent R² value (0.99) when analyzed using the intended count and flow cytometry data. The ADAMII and two flow cytometry-based assays generated very similar data for the PB and leukapheresis samples.

Conclusions

ADAMII demonstrated excellent performance for use as a routine clinical assay in terms of CD34+ cell enumeration from PB and leukapheresis samples. Moreover, it could be used as a point-of-care-test for determining mobilization time and predicting an adequate apheresis stem cell product.

Copyright © 2019. Korean Association of Medical Journal Editors.