| 沈圣,田飞,江华洲,孙国清,缪礼锋,郭晓黎,肖瑶,贾玉江,StenH.Vermund,蒋岩.应用BED．CEIA检测干血斑样本监测HIV-1发病率的可行性研究[J].Chinese journal of Epidemiology,2009,30(3):273-276 |
| 应用BED．CEIA检测干血斑样本监测HIV-1发病率的可行性研究 |
| Evaluation of BED-CEIA assay with dried blood spot specimens in China |
| Received:September 22, 2008 |
| DOI：10.3760/cma.j.issn.0254-6450.2009.03.018 |
| KeyWord: 艾滋病病毒 发病率 干血斑 |
| English Key Word: Human immunodeficiency virus Incidence Dried blood spot?? |
| FundProject:美国国立卫生院基金资助项目(IR03 AI 073134-0lA2) |
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| Abstract: |
| 目的 研究干血斑样本应用于现场HIV-1 BED-CEIA新近感染的检测以及监测HIV-1发病率的可行性. 方法 收集27个自愿咨询检测(VCT)哨点的10 313名咨询者的血浆和干血斑样本, 进行HIV抗体检测, 对经免疫印迹方法确认的349例HIV感染者的血浆和干血斑样本同时进行BED-CEIA检测, 检验干血斑样本BED-CEIA新近感染检测结果的稳定性和重复性, 比较两种样本检测结果的差异及对HIV发病率估计的一致性. 结果 应用干血斑样本检测具有较好的稳定性和重复性, R2值分别达到0. 9551和0. 95. 349对样本的检测结果显示, 294对样本被同时判定为长期感染, 53对样本被同时判定为新近感染, 两种样本对HIV-1是否为新近感染判断的一致性达到99. 43%. 而2对样本得到不同的结果, 其An值均处于临界值附近. 在人群总体水平上, 两种样本计算得到的HIV-1发病率完全一致. 结论 在HIV-1 BED-CEIA新近感染检测中, 尽管个别样本检测结果存在差异, 但在人群水平上千血斑样本的检测结果对HIV-1发病率的估计与血浆样本没有差异, 因此在中国可以应用于血斑样本进行HIV-1 BED-CEIA新近感染检测. |
| English Abstract: |
| Objective To study the feasibility of using dried blood spot(DBS)specimens in BED-CEIA assay and to estimate the HIV-1 incidence with DBS in China. Methods 10 313 participants from 27 voluntary counseling and testing(VCT)sites were enrolled in this study. Both plasma and DBS specimens were collected. 349 eligible pairs of HIV-1 positive specimens confirmed by Western Blot were available for BED-CEIA and the Results compared. Negative control, low positive control, high positive control and calibrator in DBS were used to evaluate the stability and repeatability of the detection Results of DBS specimens. Results Of the total HIV positives, 294 and 53 participants were tested as long-term or recent HIV infections by both DBS and plasma specimens. Two participants showed different Results from DBS and plasma specimens, but their final An values were close to the cutoff value of BED-CEIA assay. The concordance rate between the two types of specimens was 99. 43% and the R2 linear of the stability and repeatability Results of DBS specimens reached 0. 9551 and 0. 95, respectively. Conclusion Although some individual specimens showed different Results, the incidence rates calculated from both types of specimen were equivalent. DBS specimens were suitable for estimating the HIV incidence and could be popularized in China. However, further studies regarding window period and adjustment coefficients of BED-CEIA assay are needed. |
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