摘要
目的对卫生行业标准WS/T 404.3-2012血清钾、钠、氯参考区间进行转换,从而建立肝素钠抗凝血浆钾、钠、氯的参考区间,并验证其是否适宜于四川遂宁地区表观健康成年人群。方法参照美国临床实验室标准化委员会(NCCLS)EP9-A2文件要求,以患者新鲜肝素钠抗凝血浆样品为待评样品、血清为参比样品,对两样品间钾、钠、氯的检测结果进行配对t检验和线性回归分析,并通过回归方程对其在血清参考区间上、下限处的一致性进行评估,检测结果具有一致性时则直接引用血清参考区间,不一致时则参照CLSI C28-A3文件通过线性回归方程对行业标准中血清参考区间的上、下限进行转换,从而建立肝素钠抗凝血浆的参考区间。然后参照WS/T 402-2012文件要求,从20~79岁的健康体检成年人群中筛选参考个体,男、女每10岁至少各纳入20例,检测其肝素钠抗凝血浆钾、钠、氯的水平,并验证落在新建肝素钠抗凝血浆钾、钠、氯参考区间内的测定值是否≥90%。各年龄段符合率≥90%则表示参考区间验证通过。结果肝素钠抗凝血浆钾、钠、氯的检测结果依次为3.83±0.76mmol/L,141.7±4.5mmol/L,101.4±4.8mmol/L,血清样品检测结果则依次为4.12±0.78mmol/L,141.3±4.6mmol/L,101.4±4.8mmol/L,两种样品间比较,仅氯的检测结果差异无统计学意义(t=-0.303,P>0.05);线性回归分析显示,两种样品间钾、钠、氯检测结果的回归方程分别为Y=0.962 X-0.14,Y=0.957 X+6.46,Y=0.987 X+1.243,相关系数r分别为0.989,0.986,0.982。肝素钠抗凝血浆钠和氯在血清参考区间上、下限处的偏倚均小于WS/T 403-2012文件所规定总允许误差(TEa)的1/2,检测结果具有一致性,可直接引用行业标准中的参考区间;而钾的偏倚均大于TEa的1/2,检测结果不具有一致性,需通过回归方程对行业标准中钾参考区间的上下限进行转换。肝素钠抗凝血浆钾、钠、氯的参考区间依次为:3.23~4.96mmol/L,137~147mmol/L,99~110mmol/L,经验证各年龄段男性和女性肝素钠抗凝血浆钾、钠、氯检测结果93.21%以上落在此参考区间以内,验证均通过。结论成功建立了肝素钠抗凝血浆钾、钠、氯的参考区间,并适用于四川遂宁地区20~79岁表观健康成年人群,为肝素钠抗凝血浆钾、钠、氯检查结果的临床应用提供依据。
Objective To convert reference intervals of serum potassium,sodium and chlorine according to health industry standard WS/T 404.3-2012.The reference intervals of potassium,sodium and chlorine in heparin sodium anticoagulant plasma were established,and verified for whether this interval was suitable for apparently healthy adult population in Suining,Sichuan Province.Methods According to NCCLS EP9-A2 document requirements,using the sample of fresh Heparin sodium anticoagulant plasma and the serum sample as reference,the results of potassium,sodium,and chlorine detection between the two samples were paired with data t-test and linear regression analysis.And through the regression equation,the consistency of the serum reference interval and the lower limit were evaluated.When the detection results were consistent,the serum reference interval was directly quoted.In the event of inconsistency,the upper and lower limits of the serum reference range in the industry standard were converted by means of the linear regression equation with reference to the CLSI C28-A3 file,thus established the reference range of the anticoagulant plasma of Heparin sodium.Then,with reference to the WS/T 402-2012 document,reference individuals were selected from the adult population of 20 to 79 years of age for healthy physical examination.Men and women were included for at least 20 cases within every 10 years of age to detect the concentrations of sodium Heparin anticoagulant plasma potassium,sodium,and chlorine levels.Then we verified whether the measured values in the reference range of potassium,sodium and chlorine of the newly constructed Heparin sodium anticoagulant plasma were≥90%.Results The detection results of potassium,sodium and chlorine in anticoagulant plasma of heparin sodium were 3.83±0.76mmol/L,141.7±4.5mmol/L,101.4±4.8mmol/L,and the detection results of serum samples were 4.12±0.78 mmol/L,141.3±4.6mmol/L,101.4±4.8mmol/L.Comparison between the two samples showed no significant difference in the detection of chlorine(t=-0.303,P>0.05).Linear regression analysis showed that the regression equations of K+,Na+and Cl-were Y=0.962X-0.14,Y=0.957X+6.46,Y=0.987X+1.243,and the correlation coefficients r were 0.989,0.986 and 0.982,respectively.The bias of heparin sodium anticoagulant plasma sodium and chlorine in the upper and lower limits of serum reference interval was less than 1/2 of the total allowable error(TEa)stipulated in WS/T 403-2012.The test results were consistent and could be directly referred to the serum reference interval.The bias of potassium was greater than 1/2 of TEa,which needed further analysis by linear regression.Reference intervals of potassium,sodium and chlorine in heparin sodium anticoagulant plasma were 3.23-4.96mmol/L,137-147 mmol/L and 99-110 mmol/L,respectively.It was proved that more than 93.21%of the results of potassium,sodium and chlorine tests in male and female heparin sodium anticoagulant plasma fell within the reference interval,and all the validations were passed.Conclusion The reference intervals of potassium,sodium and chlorine in heparin sodium anticoagulant plasma have been successfully established,which can be applied to the apparent healthy adults aged 20 to 79 in Suining,Sichuan Province,and provide the basis for clinical application.
作者
肖光军
刘艳婷
杨娜
曹丹
赵思涵
李理
李祥坤
XIAO Guang-jun;LIU Yan-ting;YANG Na;CAO Dan;ZHAO Si-han;LI Li;LI Xiang-kun(Department of Clinical Laboratory,Suining Central Hospital,Suining 629000,China)
出处
《标记免疫分析与临床》
CAS
2019年第12期2115-2120,共6页
Labeled Immunoassays and Clinical Medicine
关键词
钾
钠
氯
参考区间
验证
Potassium
Sodium
Chloride
Reference interval
Validation
