Analytical goals for coagulation tests based on biological variation
Analytical goals for coagulation tests based on biological variation
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DOI：
10.1515/cclm.2004.015
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发表时间：
2004-02
期刊：
影响因子：
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通讯作者：
Y. Wada;M. Kurihara;M. Toyofuku;M. Kawamura;H. Iida;Y. Kayamori;S. Kinoshita;N. Hamasaki
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文献类型：
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作者：
Y. Wada;M. Kurihara;M. Toyofuku;M. Kawamura;H. Iida;Y. Kayamori;S. Kinoshita;N. Hamasaki
摘要实验室数据的允许不精密度和偏倚参考限可以根据生物变异的测量值来计算。尽管许多实验室报告了临床化学数据的生物学变异，但凝血试验中的生物学变异报告很少。在本研究中，我们计算了九州大学医院临床实验室的13项凝血试验的生物学变异，并确定了允许的不精密度和变异偏倚限值。参与的受试者是17名健康个体：20多岁的3名男性和2名女性，30多岁的2名男性和2名女性，40多岁的1名男性和4名女性，以及50多岁的2名男性和1名女性。从2001年6月至2002年5月，每月在早餐前进行12次测量，并计算允许的不精密度和偏倚限值。结合医院日常实验室工作中使用的对照血浆的变异系数，本研究中确定的实验室内变异的允许不精密度限度似乎在可达到的范围内。
Abstract Allowable imprecision and bias reference limits for laboratory data can be calculated based on measurements of biological variation. Although biological variation of clinical chemical data has been reported from many laboratories, there have been few reports of biological variation in coagulation tests. In this study, we calculated the biological variation of 13 coagulation tests in the clinical laboratory of Kyushu University Hospital and determined allowable imprecision and bias limits of variation. The participating subjects were 17 healthy individuals: three males and two females in their 20s, two males and two females in their 30s, one male and four females in their 40s, and two males and one female in their 50s. Monthly measurements were performed before breakfast 12 times from June 2001 to May 2002 and allowable imprecision and bias limits were calculated. Taken together with coefficient of variation of control plasma used in daily laboratory work at the hospital, the allowable imprecision limits of intra-laboratory variation determined in this study appear to be in attainable ranges.