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某ISO15189认可实验室中Sysmex HST-N302XE推片规则制订与评价

Institution and evaluation on Sysmex HST-N302XE slide rule in an ISO15189 accredited laboratory
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摘要 目的在该室Sysmex XE-2100血细胞分析仪已验证的单机模式复检规则基础上,结合国际血细胞复检规则41条,通过对实验数据进行分析,制定出适合该室Sysmex HST-N302XE血细胞分析流水线复检规则。方法将拟定的22条流水线复检规则导入HST-N302XE血细胞分析流水线操作电脑的Labman 4.2程序中,随机检测患者标本共500例,同时人工涂片做显微镜检查,包括细胞形态观察和人工白细胞分类,计算出真阳性率、假阳性率、真阴性率、假阴性率和涂片复检率。结果将人工显微镜镜检结果导入HST-N302XE血细胞分析流水线操作电脑的Labman 4.2程序中进行统计分析。自动推片率(复检率)为29.2%(146/500),真阳性率为13.0%(65/500),假阳性率为16.2%(81/500),真阴性率为69.2%(346/500),假阴性率为1.6%(8/500)。结论该室血细胞分析流水线HST-N302XE推片规则验证结果表明,假阴性率小于5%,复检率和假阳性率与文献报道基本一致,适用该室HST-N302XE血细胞分析流水线。流水线的应用能够使实验室在减少人力耗费的同时提高工作效率,保障检验质量。 Objective To establish the suitable hematology review criteria for Sysmex HST-N302XE based on the verified criteria of Sysmex XE-2100 in an ISO15189 accredited laboratory in Chongqing. Methods A total of 500 samples were randomly detected and blood smears were reviewed including observation of cell morphology and manu- al WBC differential analysis. Results According to both the hematology review criteria suggested by international consensus group and the verified criteria of Sysmex XE-2100 by this laboratory,22 items were presumed as the opti- mal hematology review criteria for Sysmex HST-N302,by which the prevalence for smear review, the true positive ra- tio(TP), the false positive ratio(FP), the true negative ratio(TN) and the false negative ratio(FN) were 29.2 ~ (146/ 500), 13.0~ (65/500), 16.2% (81/500), 69.2o//oo (346/500) and t. 6% (8/500), respectively. The validation results demonstrated that no blast cell and immature cell was missed. Conclusion The 22 items of hematology review criteria could be adaptive and efficient to assure quality of hematology results, and enhance work efficiency and reduce unnec- essary labor consuming. These criteria for Sysmex HST-N302XE might deserve more laboratory practice.
出处 《检验医学与临床》 CAS 2013年第21期2788-2790,共3页 Laboratory Medicine and Clinic
基金 国家临床重点专科建设项目经费资助[财社(2010)305号]
关键词 血细胞分析 流水线 推片率 复检规则 假阴性 blood cell analysis pipeline slide rate review criteria false negative
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