样本溶血对两种改模后的国产ELISA试剂检测HIV的影响

The impact of sample hemolysis on two mode changing reagents in HIV detection

目的探讨样本溶血对改模后的国产艾滋病病毒(HIV)酶联免疫吸附试验(ELISA)(双抗原夹心法)试剂检测结果的影响。方法将2010年1-12月收集到的阴性样本、弱阳性样本和强阳性样本,人为造成不同程度的溶血,比较溶血前后不同试剂检测样本的光密度(OD)值的变化差异,分析溶血样本是否对ELISA试验存在干扰,不同试剂间是否存在差异。结果共收集42例样本,其中阴性样本20例。试剂1检测10g/L以上溶血样本的OD值与溶血前比较差异有统计学意义(P<0.05),试剂2检测溶血样本的OD值与溶血前比较差异无统计学意义(P>0.05);对于20例弱阳性样本,2种试剂在5g/L以上溶血后,样本检测OD值与溶血前比较,差异有统计学意义(P<0.05);对于2例阳性样本,2种试剂在5g/L以上溶血后,样本检测OD值与溶血前比较差异无统计学意义(P>0.05)。结论溶血样本对改模后HIV ELISA检测结果存在多种干扰,应采取多种措施防止样本溶血,对于灰区结果和溶血样本需要重新取样,进行再检。

Objective To explore the impact of sample hemolysis on the results of domestically produced enzyme-linked immunosorbent assay （ELISA） reagents in detecting human immunodeficieney virus （HIV） after changing mode. Methods Samples including negative, weak positive and positive specimens collected from January to December of 2010 were hemolyzed artificially, then the different changing optical density（OD） values pre- and post-hemolysis were compared to analyze if there was any interference to ELISA experiment and if there were any differences between different reagents. Results A total of forty two samples were collected. For the 20 negative specimens, No. 1 reagent was used to detect the hemolyzed samples with the OD values ≥10g/L and statistically significant differences were found in comparison with those pre hemolysis （P〈 0.05） ; No. 2 reagent was used to detect the OD values of the hemolyzed samples and no statistically significant differences were found in comparison with those pre hemolysis （P〉0.05）. For the 20 weak positive specimens, two types of reagents were used to detect hemolyzed samples with OD value ≥10g/L, and it was found that olong with the degree of hemolysis rising, the OD values were decreasing, and the differences hadstatistical significance （P〈0.05）. For the two positive specimens, statistical significance （P〉 0.05） was not found between the two reagents in hemolyzed specimens with the OD value above 5 g/L pre and post hemolysis（P〉0. 05）. Conclusion Sample hemolysis has some effects on the results of HIV ELISA testing after changing mode. Various measures should be taken to prevent sample hemolysis. For the hemolyzed samples which OD values were in grey area, should be resampled and tested again.