Accuracy of home pregnancy tests at the time of missed menses
Accuracy of home pregnancy tests at the time of missed menses
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DOI：
10.1016/j.ajog.2003.08.043
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发表时间：
2004-01-01
影响因子：
9.8
通讯作者：
Rayburn, WF
中科院分区：
文献类型：
--
作者：
Cole, LA;Khanlian, SA;Rayburn, WF
目的：本研究的目的是调查月经错过前后家庭妊娠测试 (HPT) 的有效性。研究设计：在月经错过前后测定尿液中人绒毛膜促性腺激素 (hCG) 的水平，并计算第 5 个和第 95 个百分位。在一项评估 18 个品牌 HPT 的盲法研究中，每个品牌均使用 5 种浓度（0 至 100 mIU/mL）的 hCG 进行了六次测试。灵敏度定义为在建议的读数时间或延长的时间内，六个品牌中的六个给出阳性结果的浓度。 结果：估计需要 12.5 mIU/mL 的灵敏度才能检测到 95% 的月经缺失时的妊娠。 18 个 HPT 中只有 1 个具有这种敏感性。如果考虑到难以辨别的结果，18 个品牌中有 2 个给出了假阳性或无效结果。只有 44% 的品牌在 100 mIU/mL hCG 时给出了明确的阳性结果。若有人接受若隐若现并延伸。读取时间时，所有品牌的响应均为 100 mIU/mL。灵敏度为 100 mIU/mL 的测试可检测出大约 16% 的月经错过时怀孕的情况。 结论：HPT 的实用性受到质疑。临床医生需要了解当前 HPT 品牌的局限性。 (C) 2004 Elsevier Inc. 保留所有权利。
Objective: The purpose of this study was to investigate the validity of home pregnancy tests (HPTs) around the time of the missed menses.Study design: Levels of human chorionic gonadotropin (hCG) were determined in urine around the time of the missed menses, and 5th and 95th centiles were calculated. In a blind study evaluating 18 brands of HPTs, each was tested six times with five concentrations of hCG, 0 to 100 mIU/mL. Sensitivity was defined as the concentration at which six of six brands gave positive results, at the suggested reading time or at an extended time.Results: It was estimated that a sensitivity of 12.5 mIU/mL was needed to detect 95% of pregnancies at the time of missing menses. Only 1 of 18 HPTs had this sensitivity. If faintly discernible results considered, 2 of 18 brands gave false-positive or invalid results. Clear positive results were given by only 44% of the brands at 100 mIU/mL hCG. If one accepted faintly discernible and extended. reading times, all brands responded at 100 mIU/mL. A test with 100 mIU/mL sensitivity would detect approximately 16% of pregnancies at the time of missed menses.Conclusion: The utility of HPTs is questioned. Clinicians need to be aware of the limitations of current HPT brands. (C) 2004 Elsevier Inc. All rights reserved.