对五种家用妊娠试验对已知浓度人绒毛膜促性腺激素的敏感性评估。

An evaluation of the sensitivity of five home pregnancy tests to known concentrations of human chorionic gonadotropin.

作者信息

Hanlon J T, Caiola S M, Muhlbaier L H, Dennis B H, Edelman D A, Dingfelder J R

出版信息

Am J Obstet Gynecol. 1982 Dec 1;144(7):778-82. doi: 10.1016/0002-9378(82)90351-9.

Abstract

A study was conducted to evaluate the sensitivity of the five commercially available home pregnancy testing kits. Known amounts of human chorionic gonadotropin (hCG) were diluted in pooled, sterile male urine. Varying concentrations of hCG were randomly assigned to 100 kits of each of the five brands. The test results were read independently by three individuals who were blinded to the hCG concentrations. Statistical analysis were based on the majority vote of the readers. The rank-ordered sensitivity of the five home pregnancy tests, expressed as the proportion of positive results for the range of hCG concentrations studied, was as follows: (1) Predictor, (2) e.p.t., (3) Acu-Test, (4) Answer, and (5) Daisy 2. Overall, Predictor and e.p.t. appear to be more accurate than Acu-Test or Answer. Only Daisy 2 was found to be significantly different from the other brands. However, the currently marketed Daisy 2 pregnancy test is manufactured by a different company.

摘要

一项研究旨在评估五种市面上可买到的家用妊娠检测试剂盒的灵敏度。已知量的人绒毛膜促性腺激素（hCG）被稀释于汇集的无菌男性尿液中。将不同浓度的hCG随机分配给五个品牌中每个品牌的100个试剂盒。由三名对hCG浓度不知情的人员独立读取检测结果。统计分析基于读取人员的多数投票。五种家用妊娠检测的排序灵敏度，以所研究的hCG浓度范围内阳性结果的比例表示，如下：（1）Predictor，（2）e.p.t.，（3）Acu-Test，（4）Answer，以及（5）Daisy 2。总体而言，Predictor和e.p.t.似乎比Acu-Test或Answer更准确。仅发现Daisy 2与其他品牌有显著差异。然而，目前市场上销售的Daisy 2妊娠检测试剂盒由另一家公司生产。