Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices.
Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices.
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DOI：
10.1093/clinchem/47.12.2131
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发表时间：
2001-12
影响因子：
9.3
通讯作者：
S. Butler;S. Khanlian;L. Cole
中科院分区：
文献类型：
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作者：
S. Butler;S. Khanlian;L. Cole
背景技术家用妊娠检测设备声称对妊娠的诊断准确率>99%，并且在月经错过的第一天或更早有用。我们调查了早孕尿液中人绒毛膜促性腺激素 (hCG) 的形式、诊断准确性声明以及 15 种设备检测不同形式 hCG 的能力。方法 我们测量了 592 份尿液中常规 hCG 和高糖基化 hCG（H-hCG，一种大 hCG 变体）的浓度。根据制造商的说明，使用尿液中稀释的常规 hCG 和 H-hCG 对 15 种家用设备进行了测试。结果 H-hCG 是月经错过后 2 周内妊娠尿液中主要的 hCG 相关分子（在妊娠第 4 周和第 5 周分别占总免疫反应性的 61% 和 50%）。在 15 个家用测试设备中，有 2 个对常规 hCG 的检测限为 6.3 IU/L，但对 H-hCG 的检测较差。两台设备检测到 13 IU/L 常规 hCG，一台检测结果相似，另一台检测 H-hCG 较差。 10 台设备检测到 25 IU/L 常规 hCG，6 台设备检测到的 H-hCG 较差。一台设备检测到 50 IU/L 常规 hCG，但更好地检测到 H-hCG。总体而言，15 台设备中有 9 台未检测到 H-hCG 以及常规 hCG。结论 H-hCG 是早孕尿液中主要的 hCG 免疫反应性。家庭测试对常规 hCG (6.3-50 IU/L) 的检测限差异很大，15 台设备中的 9 台 (60%) 对 H-hCG 的检测限低于 hCG。分析检测限的变化似乎与所有设备在月经错过的第一天或更早检测到> 99% 的妊娠的普遍说法相矛盾。我们建议制造商针对 hCG 和 H-hCG 校准设备，并确定妊娠检出率，而不是任意 hCG 浓度下阳性结果的比例。
BACKGROUND Home pregnancy testing devices claim >99% diagnostic accuracy for pregnancy and utility on the first day of the missed menses or earlier. We investigated the forms of human chorionic gonadotropin (hCG) in early pregnancy urines, the diagnostic accuracy claim, and the abilities of 15 devices to detect the different forms of hCG. METHODS We measured the concentrations of regular hCG and hyperglycosylated hCG (H-hCG, a large hCG variant) in 592 urines. Fifteen home devices were tested according to manufacturers' instructions with regular hCG and H-hCG diluted in urine. RESULTS H-hCG was the principal hCG-related molecule in pregnancy urine in the 2 weeks following the missed menses (61% and 50% of total immunoreactivity in the 4th and 5th completed weeks of pregnancy, respectively). Of 15 home test devices, 2 had a detection limit of 6.3 IU/L for regular hCG, but poorer detection of H-hCG. Two devices detected 13 IU/L regular hCG, one with similar detection and one with poorer detection of H-hCG. Ten devices detected 25 IU/L regular hCG, 6 with poorer detection of H-hCG. One device detected 50 IU/L regular hCG, but better detected H-hCG. Overall, 9 of 15 devices did not detect H-hCG as well as regular hCG. CONCLUSIONS H-hCG is the principal hCG immunoreactivity in early pregnancy urine. Home tests vary widely in detection limits for regular hCG (6.3-50 IU/L), and 9 of 15 devices (60%) had poorer detection limits for H-hCG than for hCG. The variation in analytical detection limits appears contradictory to the common claim for all devices of >99% detection of pregnancy on the first day of the missed menses or earlier. We suggest that manufacturers calibrate devices for both hCG and H-hCG and determine the detection rates for pregnancy rather than the proportion of positive results at arbitrary hCG concentrations.