Cole L A, Seifer D B, Kardana A, Braunstein G D
Department of Obstetrics and Gynecology, Yale University School of Medicine, New Haven, CT 06510.
Am J Obstet Gynecol. 1993 May;168(5):1580-6. doi: 10.1016/s0002-9378(11)90802-3.
We investigated the variation in human chorionic gonadotropin results found with different commercial kits. Levels of human chorionic gonadotropin and related molecules were determined in pregnancy serum and urine and compared with the specificities of different laboratory, office, and home test kits.
Total human chorionic gonadotropin (nicked+nonnicked), nonnicked human chorionic gonadotropin, free beta subunit, and beta core fragment were measured in 242 serum samples and 125 urine samples from early pregnancies.
In serum, in the 2 weeks after the missed period when most pregnancy tests are performed, median levels of total, nonnicked, and beta human chorionic gonadotropin (total+free beta+beta core) were similar (< or = 12% difference). Individual values, however, varied significantly. For nonnicked human chorionic gonadotropin, values ranged from 41% to 145% and for beta from 101% to 145% of the total human chorionic gonadotropin level. In urine individual nonnicked values varied from < 1% to 148% and beta values from 102% to 547% of the total human chorionic gonadotropin level. A survey of 29 kits revealed that 10 were types detecting total human chorionic gonadotropin, five detecting nonnicked only, and 14 were beta assays.
Results from total, nonnicked, and beta human chorionic gonadotropin kits are not necessarily interconvertible. Individual variations in levels of nicked human chorionic gonadotropin, free beta and beta core, and differences in their recognition by immunoassays causes discordant results.
我们研究了不同商用试剂盒检测人绒毛膜促性腺激素结果的差异。测定了妊娠血清和尿液中人绒毛膜促性腺激素及相关分子的水平，并与不同实验室、门诊和家用检测试剂盒的特异性进行了比较。
对242份早期妊娠血清样本和125份尿液样本中的总人绒毛膜促性腺激素（缺口型+非缺口型）、非缺口型人绒毛膜促性腺激素、游离β亚基和β核心片段进行了检测。
在血清中，在大多数妊娠试验进行的月经推迟后的2周内，总、非缺口型和β人绒毛膜促性腺激素（总+游离β+β核心）的中位数水平相似（差异≤12%）。然而，个体值差异显著。对于非缺口型人绒毛膜促性腺激素，其值在总人绒毛膜促性腺激素水平的41%至145%之间，β值在101%至145%之间。在尿液中，个体非缺口型值在总人绒毛膜促性腺激素水平的<1%至148%之间，β值在102%至547%之间。对29种试剂盒的调查显示，10种检测总人绒毛膜促性腺激素，5种仅检测非缺口型，14种为β检测法。
总、非缺口型和β人绒毛膜促性腺激素试剂盒的结果不一定可相互转换。缺口型人绒毛膜促性腺激素、游离β和β核心水平的个体差异以及免疫测定对它们识别的差异导致了结果不一致。
