对用于定量血清中人绒毛膜促性腺激素的层流免疫荧光分析系统进行了评估。

The Stratus immunofluorometric assay system evaluated for quantifying human choriogonadotropin in serum.

作者信息

Rogers L C, Kahn S E, Oeser T H, Bermes E W

出版信息

Clin Chem. 1986 Jul;32(7):1402-4.

Abstract

We evaluated the Stratus (American Dade, Miami, FL), an automated immunofluorometric assay system, for the quantification of human choriogonadotropin (hCG) in serum or plasma. The assay is based on the "sandwich" (two-site) immunoassay methodology: use of two monoclonal antibodies, one specific for the alpha subunit and the other for the beta subunit, results in an assay that is specific for the intact hCG molecule. Results for the first sample are obtained in 7 min; subsequent additional values are produced at 1-min intervals. Inter-run precision (CV), estimated from replicate determinations of sera, was 4.5% at an hCG concentration of 38 int. units/L, 4.9% at 114, and 6.1% at 194. Intrarun CV was less than 2% at all three concentrations. Correlations of results for 127 specimens analyzed in duplicate with the Stratus (y) and by a radioimmunoassay (x) for beta hCG (Gamma Dab M [cf931125I] beta-hCG, Travenol-Genentech Diagnostics, Cambridge, MA) yielded the following regression equation: y = 0.969x - 6.0 (r = 0.995). The Stratus immunofluorometric system provides a rapid and convenient assay of hCG in serum or plasma.

摘要

我们评估了Stratus（美国达德公司，迈阿密，佛罗里达州）这一自动免疫荧光分析系统，用于定量检测血清或血浆中的人绒毛膜促性腺激素（hCG）。该分析基于“夹心”（双位点）免疫分析方法：使用两种单克隆抗体，一种对α亚基具有特异性，另一种对β亚基具有特异性，从而形成一种对完整hCG分子具有特异性的分析方法。第一个样本的结果在7分钟内获得；随后每隔1分钟得出其他结果。通过对血清的重复测定估算的批间精密度（CV），在hCG浓度为38国际单位/升时为4.5%，在114时为4.9%，在194时为6.1%。在所有三个浓度下，批内CV均小于2%。对127个标本进行重复分析，Stratus（y）和放射免疫分析（x）检测β-hCG（伽马达布M [cf931125I]β-hCG，特拉文诺尔-基因泰克诊断公司，马萨诸塞州剑桥）的结果相关性得出以下回归方程：y = 0.969x - 6.0（r = 0.995）。Stratus免疫荧光分析系统可对血清或血浆中的hCG进行快速便捷的检测。