干血片用于HCV抗体及RNA检测的评价

Evaluation of dried blood spot for anti-HCV and HCV-RNA testing

目的研究干血片在用于检测HCV抗体及RNA的性能评价。方法采集191例血标本制成血浆和干血片样本,用酶联免疫吸附试验(ELISA)检测HCV抗体以及用RT-PCR检测HCV-RNA;并将血浆检测HCV抗体和HCV-RNA阳性标本的干血片分别在不同温度条件下保存不同时间检测。结果干血片检测HCV抗体和HCV-RNA的灵敏度分别为97.8%、94.9%,特异度分别为100%、99.1%,与血浆比有很好的一致性;干血片在-20℃或4℃可以保存1年以上、25℃保存3个月HCV抗体结果稳定;干血片-20℃或4℃保存6个月、25℃保存1个月HCV-RNA结果稳定。结论用干血片样本检测HCV抗体及RNA与血浆样本检测结果差异无统计学意义,是血浆检测的可靠替代品,而且它在低温下保存时间长、常温也较稳定,方便保存、运送,比血浆适用范围更广范。

Objective The performance of dried blood spot（DBS） for anti-HCV and HCV-RNA testing was evaluated.Methods Paired plasma and DBS were selected from 191 people,Enzyme-linked immunosorbent assay（ELISA） was used to detect anti-HCV,and RT-PCR was used to detect HCV-RNA;Positive samples in plasma detection were detected in the DBS which stored at different temperatures and different times.Results DBS in anti-HCV and HCV-RNA testing which was observed sensitivity of 97.8%、94.9%,specificity of 100%、99.1%,was consistence with plasma;The result of anti-HCV was stable,when DBS stored at-20 ℃/4 ℃ more than a year and 25℃ 3 months;The result of HCV-RNA was stable,when DBS stored at-20 ℃/4 ℃ 6 months and 25℃ a month.Conclusion No Significantly different between the DBS and the plasma samples in detecting anti-HCV and HCV-RNA was determined in the result,so DBS was a reliable alternatives to plasma in detecting these,furthermore,DSB has a long storage at low temperature,and was relatively stable at normal temperature,facilitated preservation and transportation,therefore it used more wildly than plasma.