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雅培Cell Dyn 3500的完整分析和诊断性能。

Complete analytical and diagnostic performances of the Abbott Cell Dyn 3500.

作者信息

Sanzari M, De Toni S, D'Osualdo A, Rossetti M, Floriani F, Plebani M

机构信息

Department of Laboratory Medicine, Azienda Ospedaliera, Padua, Italy.

出版信息

Panminerva Med. 1998 Jun;40(2):116-25.

PMID:9689832
Abstract

METHODS

The study reports the analytical and diagnostic performances of Cell Dyn 3500 (Abbott), an automated haematology analyser that provides the electrical impedance and the optical detection of total leukocyte and a five population leukocyte differential count. The evaluation of complete blood count and differential leukocyte count parameters was performed following the guidelines of the International Council for Standardization in Haematology and those of the National Committee for Clinical Laboratory Standards document H20-A.

RESULTS

The CD 3500 demonstrated a good linearity, minimal carry-over, as well as acceptable levels of within and between-batch imprecision and stability. An excellent correlation between CD 3500 and the routine systems used in our laboratory (Technicon H*2 and Coulter STKS) was found for the major haematological indices, though agreement was not as good for MCHC. There was a good correlation between CD 3500 and manual reference differential method for neutrophils, lymphocytes, eosinophils and basophils, with the exception of monocytes.

CONCLUSIONS

Regarding clinical sensitivity, the CD 3500 showed a high specificity to detect morphological abnormalities, but low sensitivity especially for the identification of immature granulocytes and nucleated red blood cells; if we overall evaluate any qualitative flags, we found an appreciable increase in sensitivity.

摘要

方法

本研究报告了Cell Dyn 3500(雅培公司)的分析和诊断性能,这是一款自动血液分析仪,可提供全白细胞的电阻抗和光学检测以及五分类白细胞计数。全血细胞计数和白细胞分类计数参数的评估按照国际血液学标准化委员会的指南以及美国国家临床实验室标准委员会文件H20-A进行。

结果

CD 3500表现出良好的线性、最小的携带污染,以及批内和批间不精密度和稳定性的可接受水平。对于主要血液学指标,发现CD 3500与我们实验室使用的常规系统(Technicon H*2和库尔特STKS)之间具有良好的相关性,不过对于平均血红蛋白浓度(MCHC)的一致性没那么好。CD 3500与中性粒细胞、淋巴细胞、嗜酸性粒细胞和嗜碱性粒细胞的手工参考分类方法之间具有良好的相关性,但单核细胞除外。

结论

关于临床敏感性,CD 3500在检测形态学异常方面表现出高特异性,但敏感性较低,尤其是在识别未成熟粒细胞和有核红细胞方面;如果我们综合评估任何定性标记,则会发现敏感性有明显提高。

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Panminerva Med. 1998 Jun;40(2):116-25.
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