标本混匀方式对HIV抗原抗体酶联免疫吸附试验结果的影响

The influence of different modes of sample mixing on HIV Ag/Ab ELISA test

目的研究标本混匀方式对HIV抗原抗体(HIV Ag/Ab)酶联免疫吸附试验(enzyme linked immunosorbent assay,ELISA)结果的影响。方法使用全自动标本处理系统对北京市红十字血液中心8种类型的标本进行加样,包括4种试剂盒标本(HIV抗原阳性对照品、HIV–1抗体阳性对照品、HIV–2抗体阳性对照品和阴性对照品)、HIV–1标准物质、3种献血者血浆标本(阴性、弱阳性和阳性),根据标本混匀方式分为4组(组1~4分别为加样后抽吸混匀0次、4次、7次、10次,其中组4为对照组)。每种标本每组进行72孔重复试验,比较和分析试验有效率和S/CO值差异。结果除HIV抗原阳性对照品外,其他7种标本的4组试验有效率均为100.0%(72/72)。HIV抗原阳性对照品组1~4试验有效率分别为88.9%(64/72)、95.8%(69/72)、100.0%(72/72)和100.0%(72/72)。除HIV抗原阳性对照品外,其他7种标本4组试验S/CO差异均无统计学意义(P>0.05)。与组4(6.654)相比,HIV抗原阳性对照品的组1(5.158)和组2(6.368)结果偏低,差异有统计学意义(P<0.05),组3差异无统计学意义(P>0.05)。结论实验室应对标本加样后混匀环节进行验证,确保检测结果的准确性。

Objective To study the influence of different modes of sample mixing on the results of HIV Ag/Ab ELISA test. Methods The automatic sample processing system was used to add eight types of samples from Beijing Red Cross Blood Center, including four kinds of kit samples(HIV antigen positive control, HIV–1 antibody control, HIV–2 antibody control and negative control), HIV–1 antibody serum reference material and three kinds of blood donor plasma samples(negative, weak positive and positive). According to the mode of sample mixing, the samples were divided into four groups(group 1 – group 4: 0, four, seven and 10 times of sample mixing, and group 4 was the control group). Each sample was repeated 72 times in each group, and then the effective rate and S/CO value were compared and analyzed. Results The effective rates of the other seven samples in four groups were all 100.0%(72/72), except for HIV antigen positive control.The effective rates of group 1 to group 4 of HIV antigen control were 88.9%(64/72), 95.8%(69/72), 100.0%(72/72)and 100.0%(72/72) respectively. There was no significant difference in S/CO value among the other seven samples, except for HIV antigen positive control(P>0.05). Compared with group 4(6.654), the results of group 1(5.158) and group 2(6.368)were lower and the differences were statistically significant(P<0.05), while the difference was not statistically significant in group 3(P>0.05). Conclusions The laboratory should verify the mixing process after adding samples to ensure the accuracy of the test results.