2个检测系统测定血浆纤维蛋白原结果的偏倚评估

Bias evaluation on results of plasma Fibrinogen in two different detection Systems

目的对日本希森美康（Sysmex）CAT000全自动血凝仪（SYSMEXCA7000）与法国STAGO两台血凝仪测定血浆纤维蛋白原（Fbg）结果进行比对和偏倚评估，探讨其预期偏倚是否在临床可接受范围内，以确保向临床提供一致的检测结果。方法根据NCCLS的EP9-A2文件，对纤维蛋白原进行比对，每天留取8份临床标本，以STAGO血凝仪为比较方法，以SYSMEXCAT000为实验方法，对检测结果计算相关系数和直线回归方程，对两系统之间的预期偏差进行评估。结果当N=40时．Y=0．9854X-0．155，r^2=0．9937，当N=79时，Y=0．9923X-0．1611，r^2=0．9969，Fbg在中、高医学决定水平处均为Bc〈1／3Ea，在低医学决定水平处Bc〉Ea。结论SYSMEX测定血浆纤维蛋白原结果明显低于STA测定结果，但其预期偏倚可以被接受，因而基本可以向临床提供具有一致临床意义的检测结果。

Objective The comparison and Bias evaluation on results of plasma fibrinogen between two automatic coagulation analyzers, SYSMEX CA7000 and STA GO,to study whether the anticipated bias between two different coagulation analyzers was acceptable to ensure the accurate results for the clinic. Methods According to the profile NCCLS - EP9 - A2, eight samples were tested with fibrinogen in STA GO（comparison method） and SYSMEX CA7000（laboratory method）every day, to obtain the correlation coeffident and the linear equation.Then to evaluate the anticipated bias between these two systems.Results When the samples were 40, Y = 0.9854X - 0.155 ,r^2 = 0.9937, when the samples were 79, Y = 0.9923X - 0.1611, r^2 = 0.9969, fibrinogen was Bc 〈 1/3 Ea beth on the middle and high level of Xc, fibrinogen was Be 〉 Ea on the low level of Xe. Conelusion Results of plasma fibrinogen level detected by SYSMEX CA7000 was lower than STAGO. out the anticipated bias of tibrinogen between two different analysis Systems was basically acceptable and could offer the results of the same clinical mean for the clinic.