HBsAg两步法酶免国产试剂与进口试剂检测结果对比分析

Comparative Analysis of Detection by Domestic and Import HBsAg ELISA Reagents

目的评价国产HBsAg两步法酶免试剂，为实验室选择优质可靠的试剂提供依据。方法收集550份血清标本用美国伯乐超敏MONOLISA HBsAg ULTRAELISA试剂检测HBsAg，分成MONOLISA检测阳性组（68例）和MONO-LISA检测阴性组（482例），分别用六种国产HBsAg两步法酶免试剂复检，分析六种国产试剂的灵敏度和特异度。再将2IU／ml HBsAg标准品按1：2方法系列稀释成5个稀释度，用MONOLISA HBsAg ULTRA ELISA试剂和六种国产试剂检测，考核各试剂的分析灵敏度。结果MONOLISA检测阳性组（68例）中，国产试剂A，B和E结果相吻合，国产试剂C和D有1例漏检（χ^2=0．015，P〉0．05）；MONOLISA检测阴性组（482例）中，国产试剂A有1例假阳性（χ^2=0．002，P〉0．05），国产试剂B和E有3例假阳性（χ^2=0．002，P〉0．05），国产试剂C和D有4例假阳性（χ^2=0．002，P〉0．05）；国产试剂F多次出现“花板”现象，实验失败，不作统计。检测2IU／mlHBsAg标准品系列稀释物，MONOLISA HBsAg ULTRA ELISA试剂分析灵敏度可达0．0625IU／ml，国产试剂A，C和D分析灵敏度可达0．25IU／ml，国产试剂B和E可达到0．125IU／ml。结论大部分采用两步法的国产HBsAg酶免试剂灵敏度和特异度能满足临床需求，但仍不及进口试剂，个别小品牌试剂性能不佳。

Objective To evaluate domestic HBsAg two-steps-ELISA reagents objectively. Methods 550 serums samples were tested by American BIO-RAD MONOLISA HBsAg ULTRA ELISA reagent and divided to MONOLISA HBsAg positive group （68samples） and MONOLISA HBsAg negative group （482samples）. Then six domestic HBsAg two-steps-ELISA reagents were used to test the samples in two groups in order to compare the sensitivity and specificity of the six reagents. Additionally 2IU/ml HBsAg standard material was diluted according to 1 ： 2 for 5 series dilutions. The series dilutions were test by MONOLISA HBsAg ULTRA ELISA reagent and the six domestic HBsAg reagents. Results For 68 samples in MONOI.ISA HBsAg positive group,three domestic reagents A,B and E got the same result as MONOLISA HBsAg ULTRA ELISA reagent; two domestic reagents C and D missed one sample as false negative（χ2 = 0. 015, P〉0.05）. For 482 samples in MONOLISA HBsAg negative group, the domestic reagents A missed 1 sample as false positive （χ^2= 0. 002, P）〉 0.05）, the domestic reagents B, E missed 3 samples as false positive（ χ^2 =0. 002, P〉0. 05）, the domestic reagents C and D missed 4 sample as false positive （χ^2 = 0. 002, P〉0. 05） ;another domestic reagent F failed several times because of high OD of negative control. Conclusion Most of the domestic HBsAg two-steps-ELISA reagents can meet the need of clinical lab, but import reagent is still better. Some domestic reagents from unell-known tiny factory have a bad performance in clinical application.