Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments
Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments
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DOI：
10.1055/s-0034-1368589
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发表时间：
2014-07-01
影响因子：
2.7
通讯作者：
Johnson, S.
中科院分区：
文献类型：
--
作者：
Gnoth, C.;Johnson, S.
1976年，第一个家庭怀孕测试被引入。从那时起，妊娠试验已成为家庭中最常用的诊断方法。妊娠试验使用抗体检测人绒毛膜促性腺激素（hCG）。它是一种理想的妊娠标志物，因为它在妊娠早期迅速而持续地上升，并且可以在尿液中检测到。目前最先进的家庭妊娠测试评估尿液中发现的hCG水平，并声称在怀孕后几周内为女性提供可靠的结果。今天，在德国，有超过15种不同类型的家用验孕棒可以在柜台上买到。许多测试声称是高度准确的，能够在下一个月经期之前检测到怀孕，尽管月经前8天的说法是不现实的。然而，用户和医疗保健专业人员应该知道，尽管所有产品都被标记为CE，但目前还没有测试性能和声明的标准。本综述概述了家用妊娠试验的发展及其有效性数据，并分析了已发表的关于hCG检测早孕准确性的数据和使用家用妊娠试验的研究。提供了德国一些家用妊娠试验的初步数据，表明许多结果与包装说明书中的声明不匹配。医疗保健专业人员和妇女应该意识到，一些家庭妊娠测试的声明是不一致的，迫切需要共同的定义和测试标准。
The first home pregnancy test was introduced in 1976. Since then, pregnancy tests have become the most common diagnostic assay used at home. Pregnancy tests use antibodies to detect human chorionic gonadotropin (hCG). It is an ideal marker of pregnancy since it rises rapidly and consistently in early pregnancy and can be detected in urine. The most advanced home pregnancy test currently available assesses the level of hCG found in urine and claims to provide women with reliable results within just a few weeks of pregnancy. Today, over 15 different types of home pregnancy test are available to buy over the counter in Germany. Many tests claim to be highly accurate and capable of detecting pregnancy before the next monthly period is due, although claims such as 8 days prior to menstruation are unrealistic. However, users and healthcare professionals should be aware that, although all are labelled as CE, there are currently no standard criteria for testing performance and claims. This review provides an overview of the development of home pregnancy tests and the data on their efficacy together with an analysis of published data on the accuracy of hCG for the detection of early pregnancy and studies on the use of home-based pregnancy tests. Preliminary data on some home pregnancy tests available in Germany are presented which indicate that many results do not match the claims made in the package insert. Healthcare professionals and women should be aware that some of the claims made for home pregnancy tests are inconsistent and that common definitions and testing criteria are urgently needed.