UniCel DxH 800 Coulter血液分析仪血小板计数准确性评价

doi:10.3969/j.issn.1673-8640.2016.08.014

摘要/Abstract

摘要：

目的评估UniCel DxH 800 Coulter血液分析仪（简称UniCel DxH 800）血小板计数的准确性。方法按照美国临床和实验室标准化协会（CLSI）EP9-A2文件的要求,将UniCel DxH 800血小板计数结果与国际参考方法（流式细胞术）检测结果进行比对。选取556例临床标本（乙二胺四乙酸二钾抗凝）,其中包括血小板计数<50.0×10⁹/L的标本113例,经手工分类含巨大血小板的标本36例。所有标本同时进行UniCel DxH 800 及Coulter EPICS XL流式细胞仪检测。流式细胞术采用CD41以及CD61双抗标记法。结果 UniCel DxH 800血小板计数结果与流式细胞术结果之间具有较好的相关性（相关系数为0.994 3）。对于血小板计数<50.0×10⁹/L的标本也能较准确定量（相关系数为0.948 0）。对极低血小板计数水平（<20×10⁹/L）、较低血小板计数水平[（20~50）×10⁹/L]、低血小板计数水平[（50~100）×10⁹/L]、正常血小板计数水平[（100~275）×10⁹/L]及高血小板计数水平（>275×10⁹/L）临床标本的准确性均较高（预期偏移为12.5%,实际偏移分别为2.2%、2.5%、1.0%、0.6%和-1.7%）。对于含巨大血小板的标本,2种方法的相关系数也高达0.986 8。结论 UniCel DxH 800用于检测正常和异常的临床标本血小板计数,结果准确性均较高。

关键词: 血液分析仪, 流式细胞术, 血小板计数, 性能评价

Abstract:

Objective To evaluate the accuracy of platelet count by UniCel DxH 800 Coulter hematology analyzer. Methods The results of platelet count by UniCel DxH 800 were compared with those of international reference method（flow cytometry）,according to the Clinical and Laboratory Standards Institute（CLSI） EP9-A2. A total of 556 ethylene diamine tetraacetic acid-K₂（EDTA-K₂） anticoagulant specimens were collected,including 113 specimens with platelet count <50.0×10⁹/L and 36 specimens with giant platelets by manual identification. All specimens were analyzed by UniCel DxH 800 and Coulter EPICS XL flow cytometry using CD41 and CD61,respectively. Results The results of platelet count by UniCel DxH 800 were in good correlation with flow cytometry （correlation coefficient was 0.994 3）,even for specimens with platelet count <50.0×10⁹/L （correlation coefficient was 0.948 0）. The biases for specimens with extremely low platelet count （<20×10⁹/L）,moderately low platelet count [（20-50）×10⁹/L],low platelet count [（50-100）×10⁹/L],normal platelet count [（100-275）×10⁹/L] and high platelet count（>275×10⁹/L） were 2.2%,2.5%,1.0%,0.6% and -1.7%,respectively,which were all lower than expected bias（12.5%）. For specimens with giant platelets,the correlation coefficient of the 2 methods was 0.986 8. Conclusions Platelet count obtained from UniCel DxH 800 is accurate at all critical levels and even in the presence of giant platelets.

Key words: Hematology analyzer, Flow cytometry, Platelet count, Performance evaluation

中图分类号:

R446.1

陈骊婷, 林孝怡, 王剑飚. UniCel DxH 800 Coulter血液分析仪血小板计数准确性评价[J]. 检验医学, 2016, 31(8): 694-696.

CHEN Liting, LIN Xiaoyi, WANG Jianbiao. Accuracy of platelet count by UniCel DxH 800 Coulter hematology analyzer[J]. Laboratory Medicine, 2016, 31(8): 694-696.

图/表 4

参考文献 8

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