中国输血杂志2018，Vol.31Issue(2)：137-140,4.DOI:10.13303/j.cjbt.issn.1004-549x.2018.02.011
血液核酸检测试剂UltrioPlus与Ultrio检测结果分析及血液检测模式的探讨
Analysis of blood screening results by nucleic acid testing using ultrioplus and ultrio assays and in different screening modes
摘要
Abstract
Objective To investigate the reaction rate of nucleic acid test (NAT) in Tigris system when using ultrioplus and ultrio assasys and in different screening modes. Methods The data of NAT and EIA tests in 2011—2016 was reviewed and analyzed. The reaction rates of sero-negative blood samples were compared when using ultrioplus and ultrio assasys. In addition, the reaction rates and confirming positive rate for HBV, HCV and HIV-1 were compared between parallel test mode and the EIA-NAT mode, which runs the EIA test firstly and then the sero-negative samples were selected to run NAT test. Results During the period between 2011 and 2015, 1 412 432 donations were tested in parallel mode using Ultrio assay. The reaction rate, confirming positive rate for the three viruses and for HBV were 0. 23％、29. 20％ and 0. 07％, respectively. And the difference of reaction rate and confirming positive rate between the five years were P＜0. 05(χ2 =9. 80) and P＜0. 05(χ2 =3. 91), respectively. Ultrio assays was used to detect 1 465 864 donations, the reaction rate, confirming positive rate for the three viruses were 0. 22％ and 29. 21％, respectively. Ultrioplus detecting 261 238 donations, the reaction rate, confirming positive rate for the three viruses were 0. 33％ and 39. 12％, respectively. The indexes between Ultrio and Ultrioplus were statistically significant diference, respectively(χ2 =92. 58, P＜0. 01; χ2 =31. 07, P＜0. 01) . From Feb 2016 to Mar 2016, 51 686 donations were detected in parallel mode using Ultrio Plus assay. The reaction rate, confirming positive rate for the three viruses and for HBV were 0. 57％、22. 90％ and 0. 13％, respectively. From Apr 2016 until Dec 2016, 208962 donations were detected in EIA-NAT mode using Ultrio Plus assay. The reaction rate, confirming positive rate for the three viruses and for HBV were 0. 27％、47. 73％ and 0. 13％, respectively. The reaction rate and confirming positive rate for the three viruses were significantly different between the parallel mode and the EIA-NAT mode (χ2 =117. 90, P＜ 0. 01; χ2 =50. 15, P＜0. 01), but the confirming positive rate for HBV were not change between the two modes (both were 0. 13％) . Conclusion It is suggested that Ultrio Plus assay is more sensitive and specific than Ultrio assay. Compared to the parallel test mode, the EIA-NAT mode can effectively avoid contamination in the laboratory and minimize the false positives in NAT tests.关键词
血液核酸检测/酶联免疫试验/检测模式/假阳性Key words
blood nucleic acid detection/enzyme immunoassay/detection mode/false positive分类
医药卫生引用本文复制引用
杜荣松,王淏,梁浩坚,李仲平,林诗雅,谢君谋,黄志健,蓝岚茵,郑优荣..血液核酸检测试剂UltrioPlus与Ultrio检测结果分析及血液检测模式的探讨[J].中国输血杂志,2018,31(2):137-140,4.基金项目
广州市医药卫生科技项目(20161A011056) （20161A011056）
