采用间接法建立BV-VCA-IgA和EBV-EA-IgA定量检测的参考区间

Reference intervals of EB-VCA-IgA and EB-EA-IgA were established quantificationally by an indirect method

目的采用广东省第二中医院实验室信息管理系统(LIS)中的数据,以间接法来建立本实验室EB病毒衣壳抗原IgA抗体(EBV-VCA-IgA)和EB病毒早期抗原IgA抗体(EBV-EA-IgA)的生物参考区间。方法对2020年8月至2021年7月广东省第二中医院LIS数据进行回顾性分析,选取2160名(男998名,女1162名)20~100岁且血清天冬氨酸转氨酶(AST)、血清丙氨酸转氨酶(ALT)、总胆红素(T-BILI)、直接胆红素(D-BILI)、间接胆红素(I-BILI)、血清肌酐(CR)及尿素氮(BUN)结果正常的健康体检人群的EBV-VCA-IgA和EBV-EA-IgA检测结果,对检测结果进行性别与年龄分组。使用Kolmogorov Smirnov(K-S)检验对各组别进行正态性检验,P>0.05视为正态分布,P<0.05视为非正态分布。对于非正态分布数据,剔除大于P_(25)-3×IQR及小于P_(75)+3×IQR数据。剔除后的数据进行非参数检验,分析各组间的差异。利用P_(2.5)~P_(97.5)区间来建立EBV-VCA-IgA及EBV-EA-IgA的生物参考区间,并对参考区间进行验证。结果不同性别间的EBV-VCA-IgA参考区间差异有统计学意义(P<0.001),不同年龄组间的EBV-VCA-IgA差异无统计学意义(P=0.087)。EBV-EA-IgA不同性别间差异无统计学意义(P=0.127),不同年龄组间差异有统计学意义(P=0.004)。其中,EBV-EA-IgA 20~50岁组和≥50~70岁组分别与≥70岁组比较差异有统计学意义(P=0.002,P<0.001),EBV-EA-IgA 20~50岁组和≥50~70岁组比较差异没有统计学意义(P=0.043),合并为1组(20~70岁)建立参考区间,且与≥70岁组比较差异有统计学意义(P=0.001)。因此,EBV-VCA-IgA参考区间:男性为0.34~3.88 AU/ml、女性为0.32~3.71 AU/ml;EBV-EA-IgA参考区间:20~70岁组为0.01~1.39 AU/ml、≥70岁组为0.01~1.52 AU/ml。结论利用间接法为本实验室建立EB-VCA-IgA和EB-EA-IgA的生物参考区间,能为临床对鼻咽癌等EB病毒导致的疾病诊断提供更为准确的结果。

Objective The biological reference intervals of epstein-barr virus capsid antigen antibody(EBV-VCA-IgA)and epstein-barr virus early antigen antibody(EBV-EA-IgA)in our laboratory were established by an indirect method using the data from the laboratory information management system(LIS)of Guangdong Second Traditional Chinese Medicine Hospital.Methods The results of EBV-VCA-IgA and EBV-EA-IgA in 2160 healthy people(998 males and 1162 females)who were 20 to 100 years old with normal aspartate aminotransferase(AST),alanine aminotransferase(ALT),total bilirubin(T-BILI),direct bilirubin(D-BILI),indirect bilirubin(I-BILI),creatinine(CR),and urea nitrogen(BUN)were retrospectively analyzed by the LIS data.The results were grouped by gender and age.Kolmogorov Smirnov test(K-S test)was used to test the normality of each group.When P>0.05,it was regarded as normal distribution;when P<0.05,it was regarded as non-normal distribution.For non-normal distribution data,the data larger than P_(25)-3×IQR and less than P_(75)+3×IQR were excluded.The non-parametric test was used to analyze the data after elimination.The statistical differences between the groups were analyzed.The biological reference intervals of EBV-VCA-IgA and EBV-EA-IgA were established by the P_(2.5)-P_(97.5) intervals,and the reference intervals were verified.Results There was a statistical difference in the EBV-VCA-IgA reference interval between the males and the females(P<0.001),but no statistical difference between the age groups(P=0.087).There was no statistical difference in the EBV-EA-IgA reference interval between the males and the females(P=0.127),but was between the age groups(P=0.004).The EBV-EA-IgA reference intervals in the 20-50 years old group and the≥50-70 years old group were statistically different from that in the≥70 years old group(P=0.002 and<0.001).There was no statistical difference in the EBV-EA-IgA reference interval between the 20-50 years old group and the≥50-70 years old group(P=0.043),so these two groups were united as one group(20-70 years old)to build a reference interval,and it was statistically different from that in the≥70 years old group(P=0.001).Accordingly,the EBV-VCA-IgA reference interval was 0.34-3.88 AU/ml in the males,and was 0.32-3.71 AU/ml in the females;the EBV-EA-IgA reference interval was 0.01-1.39 AU/ml in the 20-70 years old group,and was 0.01-1.52 AU/ml in the≥70 years old group.Conclusion The indirect method was used to establish the biological reference intervals of EBV-VCA-IgA and EBV-EA-IgA in our laboratory,which could provide more accurate results for the clinical diagnosis of diseases caused by EB virus,such as nasopharyngeal carcinoma.