ELISA中和(竞争)抑制法检测HBeAb试剂盒共系统检测HBeAg结果分析

Analysis on detection of sample HBeAg by ELISA in a common measurement system with HBeAb using its EIA reagent kits by nuetralizing and competitive inhibition method.

目的探讨用中和(竞争)抑制法检测HBeAbEIA[(预包被纯化乙肝e抗体(HBeAb]商品试剂盒共系统检测乙肝e抗原(HBeAg)的可行性及结果判定方法。方法用中和(竞争)抑制法检测HBeAbELISA试剂盒共系统检测1000份随机血清(浆)标本HBeAb与HBeAg,并与常规ELISA双抗体夹心法检测HBeAg试剂盒检测HBeAg作平行对照。结果ELISA共系统检测HBeAg,其阳性检测孔显色较HBeAg阴性参比对照孔明显加深,甚至比HBeAb阴性对照孔还深(或明显加深),易于目测;其比色判定临界值(COV)易于设定(或使用HBeAg临界值血清或HBeAb阴性对照),与常规ELISA检测HBeAg比色判定无显著性差异(配对计数资料比较的χ2检验:相关检验均为P<0.005,υ=1,a=0.05;优劣检验依次为HBeAg临界值血清①P>0.900,υ=1,a=0.05;HBeAb阴性对照②0.100>P>0.050,υ=1,a=0.05;ELISA共系统检测HBeAgCOV③0.100>P>0.050,υ=1,a=0.05;但χ12<χ22<χ32)。结论用中和(竞争)抑制法检测HBeAbELISA商品试剂盒能够兼测HBeAg,在有优质现代酶标仪的实验室,可以省去常规ELISA双抗体夹心法检测HBeAg试剂盒,实用价廉,值得推广。

Objective To investigate the practicality and determinate the results of detected sample HBeAg by ELISA in a common measurement system with HBeAb using its EIA （ coating purified HBeAb） reagent kits for nuetralizing and competitive inhibition method. Methods HBeAg in 1000 random serum （or plasma） samples was measured by ELISA with a common measurement system for HBeAb using its ELISA reagent kits for nuetralizing and competitive inhibition method and the results were aslo detected by a routine ELISA for HBeAg using its EIA reagent kits by double？ antibody sandwich method as control. Results The results of detected sample HBeAg in common measurement system are easily to be differentiated with examinerg own eyes,its positive colour in holes is obviously heavier than negative reference control of HBeAg, and even its colour is still （or obviously） heavier than negative control of HBeAb;its cut off value （COV） is similar to that of routine ELISA of HBeAg and it is easier to be set up （ or COV HBeAg serum and HBeAb negative control may also be used） and the HBeAg quantitative assay of OD measurement has no significant difference between ELISA in a common measurement system and a routine ELISA of HBeAg （Х^2test of enumeration data with paired design ： in correlation test all areP 〈 0. 005,v = 1, a = 0.05 ; difference test is in proper order HBeAg serum of COV① P 〉 0. 900,v = 1, a = 0.05 ;HBeAb negative contrel②0. 100 〉 P 〉 0. 050 ,v = 1, a = 0.05 ;COV of HBeAg EIA in a common measurement system③0. 100 〉 P 〉 0. 050v = 1 a = 0.05, howeverХ1^2〈 Х2^2 〈 Х3^2 ） Conclusion The detection of sample HBeAg by ELISA in a common measurement system with HBeAb using its ELISA reagent kits by nuetralizing and competitive inhibition method is practicable, if a modem and high quality analyzer of ELISA were installed in one＇s own clinical laboratory,a routine ELISA （ a double - antibody sandwich method） reagent kits for HBeAg may be omitted. It is practicable and cheaper and it is also worthy for wide use.