检验医学
檢驗醫學
검험의학
LABORATORY MEDICINE
2015年
1期
1-6
,共6页
胡晓波%宋颖%王青%金大鸣%熊立凡
鬍曉波%宋穎%王青%金大鳴%熊立凡
호효파%송영%왕청%금대명%웅립범
血液分析仪%评价%确认%验证%数字成像%流式细胞
血液分析儀%評價%確認%驗證%數字成像%流式細胞
혈액분석의%평개%학인%험증%수자성상%류식세포
Haematology analyzer%Evaluation%Validation%Verification%Digital imaging%Flow cytometry
介绍了2014年国际血液学标准化委员会（ICSH）关于血液分析仪的性能评价指南。该指南从仪器的进样模式、批内精密度、批间精密度、携带污染、线性、标本稳定性、参考区间、准确性和可比性等方面对厂商提出了具体确认、评价的方法和要求，并推荐对流式细胞术和／或数字成像技术的白细胞分类计数、有核红细胞计数和未成熟粒细胞计数采用流式细胞免疫表型参考方法进行评价。每个临床实验室在仪器用于患者标本检测前，应对上述性能进行部分确认或转移。
介紹瞭2014年國際血液學標準化委員會（ICSH）關于血液分析儀的性能評價指南。該指南從儀器的進樣模式、批內精密度、批間精密度、攜帶汙染、線性、標本穩定性、參攷區間、準確性和可比性等方麵對廠商提齣瞭具體確認、評價的方法和要求，併推薦對流式細胞術和／或數字成像技術的白細胞分類計數、有覈紅細胞計數和未成熟粒細胞計數採用流式細胞免疫錶型參攷方法進行評價。每箇臨床實驗室在儀器用于患者標本檢測前，應對上述性能進行部分確認或轉移。
개소료2014년국제혈액학표준화위원회（ICSH）관우혈액분석의적성능평개지남。해지남종의기적진양모식、비내정밀도、비간정밀도、휴대오염、선성、표본은정성、삼고구간、준학성화가비성등방면대엄상제출료구체학인、평개적방법화요구，병추천대류식세포술화／혹수자성상기술적백세포분류계수、유핵홍세포계수화미성숙립세포계수채용류식세포면역표형삼고방법진행평개。매개림상실험실재의기용우환자표본검측전，응대상술성능진행부분학인혹전이。
Introduces the International Council for Standardization in Haematology (ICSH)guideline for the evaluation of blood cell analyzers,2014 edition.In this guideline,the performance evaluation,including sampling mode,within-run precision,between-run precision,carry-over,linearity,sample stability,reference interval,accuracy and comparability of haematology analyzers,should be conducted through validation and verification by manufacturers. The assessment of flow cytometry-based or digital imaging-based leukocyte differential count,nucleated red blood cell count and immature granulocyte count is recommended by flow cytometry immune-phenotypic counting as a reference method.A part of validation or transference of instrument should be performed by each clinical laboratory before reporting patient results.
