Laeyendecker Oliver, Brookmeyer Ron, Oliver Amy E, Mullis Caroline E, Eaton Kevin P, Mueller Amy C, Jacobson Lisa P, Margolick Joseph B, Brown Joelle, Rinaldo Charles R, Quinn Thomas C, Eshleman Susan H
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland 21205, USA.
AIDS Res Hum Retroviruses. 2012 Aug;28(8):816-22. doi: 10.1089/aid.2011.0258. Epub 2011 Dec 1.
The BED capture enzyme immunoassay (BED-CEIA) was developed for estimating HIV incidence from cross-sectional data. This assay misclassifies some individuals with nonrecent HIV infection as recently infected, leading to overestimation of HIV incidence. We analyzed factors associated with misclassification by the BED-CEIA. We analyzed samples from 383 men who were diagnosed with HIV infection less than 1 year after a negative HIV test (Multicenter AIDS Cohort Study). Samples were collected 2-8 years after HIV seroconversion, which was defined as the midpoint between the last negative and first positive HIV test. Samples were analyzed using the BED-CEIA with a cutoff of OD-n ≤ 0.8 for recent infection. Logistic regression was used to identify factors associated with misclassification. Ninety-one (15.1%) of 603 samples were misclassified. In multivariate models, misclassification was independently associated with highly active antiretroviral treatment (HAART) for >2 years, HIV RNA <400 copies/ml, and CD4 cell count <50 or <200 cells/mm(3); adjusted odds ratios (OR) and 95% confidence intervals (CI) were 4.72 (1.35-16.5), 3.96 (1.53-10.3), 6.85 (2.71-17.4), and 11.5 (3.64-36.0), respectively. Among 220 men with paired samples, misclassification 2-4 years after seroconversion was significantly associated with misclassification 6-8 years after seroconversion [adjusted OR: 25.8 (95% CI: 8.17-81.5), p<0.001] after adjusting for race, CD4 cell count, HIV viral load, and HAART use. Low HIV viral load, low CD4 cell count, and >2 years of HAART were significantly associated with misclassification using the BED-CEIA. Some men were persistently misclassified as recently infected up to 8 years after HIV seroconversion.
BED捕获酶免疫测定法（BED-CEIA）是为根据横断面数据估算HIV发病率而开发的。该测定法会将一些非近期感染HIV的个体误分类为近期感染，从而导致对HIV发病率的高估。我们分析了与BED-CEIA误分类相关的因素。我们分析了来自383名男性的样本，这些男性在HIV检测呈阴性后不到1年被诊断出感染HIV（多中心艾滋病队列研究）。样本在HIV血清转化后2至8年收集，HIV血清转化定义为最后一次阴性和第一次阳性HIV检测之间的中点。使用BED-CEIA对样本进行分析，近期感染的临界值为OD-n≤0.8。采用逻辑回归来确定与误分类相关的因素。603个样本中有91个（15.1%）被误分类。在多变量模型中，误分类与接受高效抗逆转录病毒治疗（HAART）超过2年、HIV RNA<400拷贝/ml以及CD4细胞计数<50或<200个细胞/mm³独立相关；调整后的优势比（OR）和95%置信区间（CI）分别为4.72（1.35-16.5）、3.96（1.53-10.3）、6.85（2.71-17.4）和11.5（3.64-36.0）。在220名有配对样本的男性中，在调整种族、CD4细胞计数、HIV病毒载量和HAART使用情况后，血清转化后2至4年的误分类与血清转化后6至8年的误分类显著相关[调整后的OR：25.8（95%CI：8.17-81.5），p<0.001]。低HIV病毒载量、低CD4细胞计数以及超过2年的HAART与使用BED-CEIA的误分类显著相关。一些男性在HIV血清转化后长达8年一直被误分类为近期感染。
