国产酶联免疫试剂检测登革热效能评价

发布时间：2018-05-24 13:06

  本文选题：登革热 + 登革病毒　； 参考：《中国病原生物学杂志》2017年05期

【摘要】：目的评价我国研制的酶联免疫试剂检测登革热病毒的效能,推进国产登革热检测剂的研发。方法采用我国研制的酶联免疫试剂对已知登革热NS1阳性血清和阴性血清进行检测,对已知阳性血清中检测阴性的血清和已知阴性血清中检测阳性血清进行PCR扩增,以排除假阴性或假阳性。根据检测结果,计算阳性符合率(真阳性率)、阴性符合率(真阴性率),进行配对资料的χ2检验,对试剂盒的灵敏度和特异性等进行综合评估。结果国产酶联免疫试剂检测已知登革热患者血清108份均阳性,阳性符合率(真阳性率)为100%,假阴性率为0。检测139份已知阴性血清,其中127份阴性,12份阳性(核酸检测为阴性),阴性符合率(真阴性率)为91.37%,假阳性率为8.63%。检测15份干扰标本均阴性,干扰标本符合率为100%。国产酶联免疫试剂与美国NS1试剂盒检测的总符合率为95.14%,两种方法的检测结果差异有统计学意义(χ~2=4.6,P0.05)。结论国产酶联免疫试剂检测登革热的灵敏度高,但特异性较美国NS1试剂盒差。
[Abstract]:Objective to evaluate the efficacy of enzyme linked immunosorbent (Elisa) developed in China for the detection of dengue virus and to promote the development of domestic dengue detection agent. Methods NS1 positive serum and negative serum of dengue fever were detected by enzyme-linked immunosorbent assay (Elisa) developed in China, and PCR amplification was carried out in the serum that was negative and negative in known positive serum. To exclude false negative or false positive. According to the test results, the positive coincidence rate (true positive rate) and negative coincidence rate (true negative rate) were calculated. The 蠂 2 test of paired data was carried out, and the sensitivity and specificity of the kit were comprehensively evaluated. Results 108 serum samples of known dengue fever patients were detected by domestic enzyme linked immunosorbent assay (Elisa). The positive coincidence rate (true positive rate) was 100 and false negative rate was 0. Of 139 known negative sera, 127 were negative and 12 were positive (nucleic acid test was negative, negative coincidence rate (true negative rate) was 91.37, false positive rate was 8.63. All 15 samples were negative, and the coincidence rate was 100%. The total coincidence rate between the domestic Elisa kit and the NS1 kit was 95.14, and the difference between the two methods was statistically significant (蠂 ~ (2 +) 4.6U P0.05). Conclusion Enzyme-linked immunosorbent assay is more sensitive than NS1 kit in detecting dengue fever.
【作者单位】： 曲靖市第一人民医院生物实验室;昆明市中医医院康复科;大理大学病原生物研究所;云南省寄生虫病防治所云南省疟疾研究中心;
【基金】：云南省惠民科技计划项目(No.2016RA010) 上海市2015年度“科技创新行动计划”国内合作项目(No.15495800400)
【分类号】：R512.8
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本文编号：1929166