RESEARCH OF HEMATOLOGY REFERENCE SAMPLES FOR EXTERNAL QUALITY ASSESSMENT WITH HIGH CONCENTRATION

Ngọc Nguyên Võ 1,2,3,, Hữu Tâm Trần3, Thị Hồng Phương Nguyễn3, Đình Dũng Vũ3, Thúy Hương Trần1,2
1 HCMUT
2 VNUHCM
3 Ho Chi Minh City Center for Testing and Calibration

Main Article Content

Abstract

Hematological reference samples for external quality assessment (EQA) in hematology are essential in Vietnam. This study attempted to establish an optimal formula for manufacture of hematological reference samples with high concentration. Three main factors affecting the concentrations of RBCs (/L) determined using Plackett-Burmann matrix were the serum (% v/v), neomycin sulfate (g/L), and glycerol (%v/v) with a significance level of 0.1. The optimal concentrations determined by RSM-CCD were 46.46% serum, 0.82 g/L neomycin sulfate, and 1.22% glycerol. The model predicted the maximum number of human RBCs was 5.1 x 1012 cells/L, pseudo-leucocytes was 16.2 x 109 cells/L, and pseudo-platelets was 449 x109 cells/L. The practical concentrations of RBCs, pseudo-leucocytes and pseudo-platelets were 5.06 x 1012 cells/L, 16.0 x 109 cells/L and 450.33 x 109 cells/L, respectively, which showed 99.23 % similarity with theoretical data; homogeneity and stability under laboratory conditions for 3 months at 2-8°C and transport conditions. This result could be a premise for further study to improve manufacturing of hematological reference samples for hematology EQA programs.

Article Details

References

1. Bộ Y Tế, 01/2013/TT-BYT - Thông tư Hướng dẫn thực hiện quản lý chất lượng xét nghiệm tại cơ sở khám bệnh, chữa bệnh. 2013.
2. Trần Hữu Tâm, et al., Ngoại Kiểm tra chất lượng xét nghiệm. 2012: Nhà xuất bản y học, Tp.HCM.
3. Trần Hữu Tâm and L.T.T. Như, Nội kiểm tra chất lượng xét nghiệm. 2012: Nhà xuất bản y học, Tp.HCM.
4. Kim et al., Hematology reference control and method of preparation, United States Patent,1999, US5858790.
5. Y. Kawai et al., Japanese Society for Laboratory Hematology flow cytometric reference method of determining the differential leukocyte count: external quality assurance using fresh blood samples, International Journal of Laboratory Hematology, 2017, 39, 202–222.
6. Plackett R. L., Burman J. P., 1946. The design of optimum multifactorial experiments. Biometrika, 33: 305-325.
7. Myers, H.R., Khuri, A.I. and Carter, W.H, 1989. Response Surface Methodology: 1966-1988. Technometrics. 31: 137-157.
8. A. M. Diks et al., Impact of blood storage and sample handling on quality of high dimensional flow cytometric data in multicenter clinical research, Journal of Immunological Methods, 2019, 475:112616.