本文選題：艾滋病抗體　切入點：口腔分泌物　出處：《南京醫(yī)科大學學報(自然科學版)》2017年06期 　論文類型：期刊論文

【摘要】：目的:評價一種HIV-1/2抗體口腔分泌物快速檢測試劑的敏感性和特異性,及其與血液HIV-1/2抗體檢測試劑的一致性,為擴大檢測提供便捷的檢測手段。方法:采集同一受試者的口腔分泌物和血液樣本,用評估試劑檢測口腔分泌物、用參比試劑檢測血液樣本,評估試劑與參比試劑檢測結果不符時,用第三方試劑(確證試劑)進行確證實驗。將評估試劑與參比試劑的檢測結果進行比較分析,評價評估試劑的敏感性、特異性、功效率等指標。結果:該臨床試驗共獲得有效樣本402例,評估試劑與參比試劑檢測結果一致的有399例,其中238例陰性樣本結果均一致,164例陽性樣本中161例結果一致,3例樣本評估試劑檢測為陰性、參比試劑檢測為陽性,確證試劑檢測均為陽性;評估試劑假陰性3例,假陽性0例。評估試劑與參比試劑的陽性符合率為98.17%,陰性符合率為100.00%,總符合率為99.26%;評估試劑對口腔分泌物樣本的主要檢測指標為:敏感性98.17%,特異性100.00%,功效率99.26%。結論:該評估試劑已達到較好的應用性能,與參比試劑的檢測結果具有高度一致性,可以為特殊場所、特殊人群提供一種低風險而便捷的檢測手段。
[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.
【作者單位】： 江蘇省疾病預防控制中心性病艾滋病防制所;
【基金】：江蘇省社會發(fā)展面上項目(BE2016631)
【分類號】：R512.91
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本文編號：1648781