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孕妇人类免疫缺陷病毒酶免疫测定假阳性结果。

False-positive human immunodeficiency virus enzyme immunoassay results in pregnant women.

机构信息

Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.

出版信息

PLoS One. 2011 Jan 27;6(1):e16538. doi: 10.1371/journal.pone.0016538.

Abstract

OBJECTIVE

Examine whether false-positive HIV enzyme immunoassay (EIA) test results occur more frequently among pregnant women than among women who are not pregnant and men (others).

DESIGN

To obtain a large number of pregnant women and others tested for HIV, we identified specimens tested at a national laboratory using Genetic Systems HIV-1/HIV-2 Plus O EIA from July 2007 to June 2008.

METHODS

Specimens with EIA repeatedly reactive and Western blot-negative or indeterminate results were considered EIA false-positive. We compared the false-positive rate among uninfected pregnant women and others, adjusting for HIV prevalence. Among all reactive EIAs, we evaluated the proportion of false-positives, positive predictive value (PPV), and Western blot bands among indeterminates, by pregnancy status.

RESULTS

HIV prevalence was 0.06% among 921,438 pregnant women and 1.34% among 1,103,961 others. The false-positive rate was lower for pregnant women than others (0.14% vs. 0.21%, odds ratio 0.65 [95% confidence interval 0.61, 0.70]). Pregnant women with reactive EIAs were more likely than others (p<0.01) to have Western blot-negative (52.9% vs. 9.8%) and indeterminate results (17.0% vs. 3.7%) and lower PPV (30% vs. 87%). The p24 band was detected more often among pregnant women (p<0.01).

CONCLUSIONS

False-positive HIV EIA results were rare and occurred less frequently among pregnant women than others. Pregnant women with reactive EIAs were more likely to have negative and indeterminate Western blot results due to lower HIV prevalence and higher p24 reactivity, respectively. Indeterminate results may complicate clinical management during pregnancy. Alternative methods are needed to rule out infection in persons with reactive EIAs from low prevalence populations.

摘要

目的

研究 HIV 酶免疫吸附试验(EIA)假阳性结果在孕妇中的发生率是否高于非孕妇和男性(其他人群)。

设计

为了获得大量的孕妇和其他人群的 HIV 检测样本,我们从 2007 年 7 月至 2008 年 6 月,鉴定了在国家实验室使用 HIV-1/HIV-2 Plus O EIA 进行检测的标本。

方法

EIA 重复反应且 Western blot 阴性或不确定结果的标本被认为是 EIA 假阳性。我们比较了未感染孕妇和其他人群的假阳性率,并对 HIV 流行率进行了调整。在所有阳性的 EIA 中,我们评估了妊娠状态下不确定结果的假阳性比例、阳性预测值(PPV)和 Western blot 带。

结果

921438 名孕妇中 HIV 流行率为 0.06%,1103961 名其他人群中 HIV 流行率为 1.34%。孕妇的假阳性率低于其他人群(0.14% vs. 0.21%,比值比 0.65[95%置信区间 0.61,0.70])。与其他人群相比(p<0.01),EIA 阳性的孕妇更有可能出现 Western blot 阴性(52.9% vs. 9.8%)和不确定结果(17.0% vs. 3.7%),PPV 更低(30% vs. 87%)。p24 带在孕妇中更常见(p<0.01)。

结论

HIV EIA 假阳性结果罕见,且在孕妇中的发生率低于其他人群。EIA 阳性的孕妇由于 HIV 流行率较低和 p24 反应性较高,Western blot 阴性和不确定结果的可能性更大。不确定结果可能会使妊娠期间的临床管理复杂化。对于来自低流行人群中 EIA 阳性者,需要替代方法来排除感染。

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