Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah.
ARUP Institute for Clinical and Experimental Pathology, ARUP Laboratories, Salt Lake City, Utah.
Fertil Steril. 2014 Jun;101(6):1671-4. doi: 10.1016/j.fertnstert.2014.02.023. Epub 2014 Mar 22.
To determine the effect that lack of hCG assay harmonization has on the interpretation of a serum hCG concentration with regards to the hCG discriminatory zone.
A multisite method comparison study.
Clinical laboratories.
PATIENT(S): Eighty serum samples containing various concentrations of hCG.
INTERVENTION(S): None.
MAIN OUTCOME MEASURE(S): Concentrations of hCG obtained from seven hCG reagent platforms.
RESULT(S): The hCG concentrations were significantly different across hCG reagent platforms. Seventy-one percent of assay pairs showed significant differences with samples selected based on hCG concentrations between 1,500 and 3,500 IU/L as determined by a comparative method. Relative to the comparative method, the calculated hCG discriminatory zones for five assays were within 9%, and one assay was within 40% of the target concentrations of 1,500 and 3,500 IU/L.
CONCLUSION(S): Despite significant differences in hCG concentrations across hCG immunoassays, an hCG concentration within a discriminatory zone of 1,500-3,500 IU/L can be used for all but one commonly used hCG reagent platform.
确定缺乏 hCG 检测标准化对血清 hCG 浓度与 hCG 鉴别区间解读的影响。
多地点方法比较研究。
临床实验室。
80 份含有不同 hCG 浓度的血清样本。
无。
来自七种 hCG 试剂平台的 hCG 浓度。
hCG 试剂平台之间的 hCG 浓度存在显著差异。根据比较方法确定的 1500 至 3500IU/L 之间 hCG 浓度，71%的检测对显示出显著差异。与比较方法相比，五个检测的计算 hCG 鉴别区间在 9%以内，一个检测在 1500 和 3500IU/L 的目标浓度内相差 40%以内。
尽管 hCG 免疫测定之间存在 hCG 浓度的显著差异，但在 1500-3500IU/L 的鉴别区间内的 hCG 浓度可用于除一个常用 hCG 试剂平台以外的所有平台。
