中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2011年
10期
945-948
,共4页
陆红%李臣宾%谷小林%彭明婷
陸紅%李臣賓%穀小林%彭明婷
륙홍%리신빈%곡소림%팽명정
参考标准%血小板计数%校准%可重复性,结果
參攷標準%血小闆計數%校準%可重複性,結果
삼고표준%혈소판계수%교준%가중복성,결과
Reference standards%Platelet count%Calibration%Reproducibility of results
目的 评价二级标准检测系统测定血小板结果的准确性与可比性,以确认新鲜血定值结果的准确和可靠程度.方法 参照美国CLSI文件EP9-A2,将二级标准检测系统与参考方法的血小板计数结果进行比对,评价40份静脉血标本检测结果的相关性和偏倚；将NCCL和日本参考实验室的二级标准检测系统的检测结果进行比对；用二级标准检测系统对36份正常新鲜血标本进行定值,将其作为校准物,用于常规实验室36台血细胞分析仪的校准.结果 二级标准检测系统与参考方法检测结果分布范围分别为(108 ～326)×109/L和(110～327)×109/L,具有良好的相关性,相关系数(r)为0.993,偏倚分布范围为-3.8％～3.4％.2009-2010年NCCL检测质控品的结果分布范围为(185 ～203)×109/L,日本参考实验室检测质控品的结果分布范围为(185～ 198)×109/L,比对数据的CV分别为2.0％～3.0％和2.6％ ～3.4％,比对数据的偏倚分布范围为-1.4％～3.7％；验证结果符合要求的20台血细胞分析仪的偏倚分布范围为-2.6％～2.1％,其余需要校准的16台血细胞分析仪校准前后的偏倚由3.4％ ～ 12.6％降至0％ ～2.8％.结论 参考实验室间的结果比对保证了血小板计数结果的准确性和可比性；二级标准检测系统定值的新鲜血作为校准物用于血细胞分析仪的校准是可行的.
目的 評價二級標準檢測繫統測定血小闆結果的準確性與可比性,以確認新鮮血定值結果的準確和可靠程度.方法 參照美國CLSI文件EP9-A2,將二級標準檢測繫統與參攷方法的血小闆計數結果進行比對,評價40份靜脈血標本檢測結果的相關性和偏倚；將NCCL和日本參攷實驗室的二級標準檢測繫統的檢測結果進行比對；用二級標準檢測繫統對36份正常新鮮血標本進行定值,將其作為校準物,用于常規實驗室36檯血細胞分析儀的校準.結果 二級標準檢測繫統與參攷方法檢測結果分佈範圍分彆為(108 ～326)×109/L和(110～327)×109/L,具有良好的相關性,相關繫數(r)為0.993,偏倚分佈範圍為-3.8％～3.4％.2009-2010年NCCL檢測質控品的結果分佈範圍為(185 ～203)×109/L,日本參攷實驗室檢測質控品的結果分佈範圍為(185～ 198)×109/L,比對數據的CV分彆為2.0％～3.0％和2.6％ ～3.4％,比對數據的偏倚分佈範圍為-1.4％～3.7％；驗證結果符閤要求的20檯血細胞分析儀的偏倚分佈範圍為-2.6％～2.1％,其餘需要校準的16檯血細胞分析儀校準前後的偏倚由3.4％ ～ 12.6％降至0％ ～2.8％.結論 參攷實驗室間的結果比對保證瞭血小闆計數結果的準確性和可比性；二級標準檢測繫統定值的新鮮血作為校準物用于血細胞分析儀的校準是可行的.
목적 평개이급표준검측계통측정혈소판결과적준학성여가비성,이학인신선혈정치결과적준학화가고정도.방법 삼조미국CLSI문건EP9-A2,장이급표준검측계통여삼고방법적혈소판계수결과진행비대,평개40빈정맥혈표본검측결과적상관성화편의；장NCCL화일본삼고실험실적이급표준검측계통적검측결과진행비대；용이급표준검측계통대36빈정상신선혈표본진행정치,장기작위교준물,용우상규실험실36태혈세포분석의적교준.결과 이급표준검측계통여삼고방법검측결과분포범위분별위(108 ～326)×109/L화(110～327)×109/L,구유량호적상관성,상관계수(r)위0.993,편의분포범위위-3.8％～3.4％.2009-2010년NCCL검측질공품적결과분포범위위(185 ～203)×109/L,일본삼고실험실검측질공품적결과분포범위위(185～ 198)×109/L,비대수거적CV분별위2.0％～3.0％화2.6％ ～3.4％,비대수거적편의분포범위위-1.4％～3.7％；험증결과부합요구적20태혈세포분석의적편의분포범위위-2.6％～2.1％,기여수요교준적16태혈세포분석의교준전후적편의유3.4％ ～ 12.6％강지0％ ～2.8％.결론 삼고실험실간적결과비대보증료혈소판계수결과적준학성화가비성；이급표준검측계통정치적신선혈작위교준물용우혈세포분석의적교준시가행적.
Objective To evaluate the accuracy and comparability of secondary hematology analyzer for platelet enumeration in order to determine the accuracy and reliability of assigned value of fresh blood.Methods The results between secondary standard hematology analyzer and the reference method of platelet enumeration of 40 specimens were compared according to the document from CLSI EP9-A2.The correlation and bias were calculated.At the same time,the results of secondary standard hematology analyzer between our laboratory and Japan reference laboratory were compared.The fresh blood from normal people was prepared to be used as calibrator after assigned value by secondary standard hematology analyzer.And 36 hematology analyzers were performed correctness validation and calibrated by 36 fresh bloods.Results The results of 40 specimens by secondary standard hematology analyzer and the reference method were ( 108 -326) × 109/L and( 110 -327 ) × 109/L respectively.Correlation coefficient between the secondary standard hematology analyzer and the reference method was 0.993.The bias between two methods was from -3.8％to 3.4％.The results of NCCL and Japan reference laboratory from 2009 to 2010 were( 185 -203) × 109/L and (185 - 198) × 109/L The bias range between our laboratory and reference laboratory in Japan was from - 1.4％ to 3.7％.The ranges of coefficient variations of two laboratories were from 2.0％ to 3.0％ and from 2.6％ to 3.4％,respectively.The biases of 20 hematology analyzers were from - 2.6％ to 2.1％ and they passed the correctness validation.The biases of 16 hematology analyzers were decreased from 3.4％ - 12.6％of pre-calibration to 0％ - 2.8％ of post-calibration.Conclusions The results of secondary standard hematology analyzer are assured to be accurate and comparable by the comparison of reference laboratories.It is feasible that fresh blood assigned value by secondary standard hematology analyzer can be used as calibrator for the hematology analyzer.
