一种HIV抗体口腔分泌物快速检测试剂的临床评价

发布时间：2018-03-22 13:07

  本文选题：艾滋病抗体　切入点：口腔分泌物　出处：《南京医科大学学报(自然科学版)》2017年06期 　论文类型：期刊论文

【摘要】：目的:评价一种HIV-1/2抗体口腔分泌物快速检测试剂的敏感性和特异性,及其与血液HIV-1/2抗体检测试剂的一致性,为扩大检测提供便捷的检测手段。方法:采集同一受试者的口腔分泌物和血液样本,用评估试剂检测口腔分泌物、用参比试剂检测血液样本,评估试剂与参比试剂检测结果不符时,用第三方试剂(确证试剂)进行确证实验。将评估试剂与参比试剂的检测结果进行比较分析,评价评估试剂的敏感性、特异性、功效率等指标。结果:该临床试验共获得有效样本402例,评估试剂与参比试剂检测结果一致的有399例,其中238例阴性样本结果均一致,164例阳性样本中161例结果一致,3例样本评估试剂检测为阴性、参比试剂检测为阳性,确证试剂检测均为阳性;评估试剂假阴性3例,假阳性0例。评估试剂与参比试剂的阳性符合率为98.17%,阴性符合率为100.00%,总符合率为99.26%;评估试剂对口腔分泌物样本的主要检测指标为:敏感性98.17%,特异性100.00%,功效率99.26%。结论:该评估试剂已达到较好的应用性能,与参比试剂的检测结果具有高度一致性,可以为特殊场所、特殊人群提供一种低风险而便捷的检测手段。
[Abstract]:Objective: to evaluate the sensitivity and specificity of a rapid detection reagent for oral secretion of HIV-1/2 antibody and its consistency with that of blood HIV-1/2 antibody assay. Methods: the oral secretions and blood samples of the same subjects were collected, the oral secretions were detected with the evaluation reagent, and the blood samples were detected with the reference reagent. When the test results of evaluation reagent and reference reagent are inconsistent, the third party reagent (confirmatory reagent) is used to carry out the confirmation experiment. The test results of evaluation reagent and reference reagent are compared and analyzed, and the sensitivity and specificity of the evaluation reagent are evaluated. Results: a total of 402 effective samples were obtained in this clinical trial, 399 of which were consistent with the results of the evaluation reagent and the reference reagent. The results of 238 negative samples were consistent with that of 164 positive samples, 161 of which were consistent with the results of 3 samples tested negative by evaluation reagent, positive by reference reagent, positive by confirmatory reagent, and 3 by false negative of evaluation reagent. The positive coincidence rate between the evaluation reagent and the reference reagent was 98.17, the negative coincidence rate was 100.00000, the total coincidence rate was 99.26.The main indicators of the evaluation reagent for oral secretion samples were as follows: sensitivity 98.17, specificity 100.00,work efficiency 99.26. Conclusion: the evaluation reagent has achieved good performance in application. It has high consistency with reference reagent and can provide a low risk and convenient detection method for special place and special population.
【作者单位】： 江苏省疾病预防控制中心性病艾滋病防制所;
【基金】：江苏省社会发展面上项目(BE2016631)
【分类号】：R512.91
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本文编号：1648781