Sugie Yuuko, Igami Ko, Shoji Keiichi, Arai Nozomi, Tazaki Yukiko, Kouta Hideki, Okamura Yoshikazu, Tashiro Shigeru, Yokoi Hiroyuki
Research and Development Division, Mitsubishi Chemical Medience Corporation, Chiba, Japan.
Clin Lab. 2011;57(1-2):99-106.
The purpose of this study was to evaluate the validity of the PATHFAST fertility marker assays for the rapid measurement of female hormones including: LH, FSH, Estradiol (E2), Progesterone (P4), Prolactin (PRL), and HCG. As for the PATHFAST fertility marker assays, female hormones can be measured by whole blood, plasma, and serum.
The correlation of the heparin whole blood and the plasma samples in the PATHFAST was examined. The method comparison study of PATHFAST fertility marker assays was performed with the Elecsys 2010, AIA-360, IMMULITE 2000, miniVIDAS, and ARCHITECT i2000. Determination of the reference range values of the PATHFAST fertility marker assays was performed with serum samples which were obtained during the follicular phase, mid-cycle, luteal phase, and postmenopausal phase.
The results of plasma samples of female hormones measured by the PATHFAST correlated highly with those of whole blood samples (r > 0.9). The results of LH, FSH, E2, P4, PRL, and HCG as measured by the PATHFAST correlated well with other commercial fertility assays (r > 0.9). Reference values of PATHFAST fertility marker assays were equivalent to those of other commercial methods.
The PATHFAST system is an accurate diagnostic tool for the rapid assay of female hormones. The PATHFAST fertility marker assays can be useful in a physician's office laboratory (POL) as well as various clinical sites during infertility treatment.
本研究的目的是评估用于快速检测包括促黄体生成素（LH）、促卵泡生成素（FSH）、雌二醇（E2）、孕酮（P4）、催乳素（PRL）和人绒毛膜促性腺激素（HCG）在内的女性激素的PATHFAST生育标志物检测法的有效性。对于PATHFAST生育标志物检测法而言，可通过全血、血浆和血清来检测女性激素。
检测了PATHFAST中肝素抗凝血全血与血浆样本的相关性。采用Elecsys 2010、AIA - 360、IMMULITE 2000、miniVIDAS和ARCHITECT i2000对PATHFAST生育标志物检测法进行方法比较研究。使用在卵泡期、月经周期中期、黄体期和绝经后阶段采集的血清样本确定PATHFAST生育标志物检测法的参考范围值。
PATHFAST检测的女性激素血浆样本结果与全血样本结果高度相关（r > 0.9）。PATHFAST检测的LH、FSH、E2、P4、PRL和HCG结果与其他商用生育检测法相关性良好（r > 0.9）。PATHFAST生育标志物检测法的参考值与其他商用方法相当。
PATHFAST系统是一种用于快速检测女性激素的准确诊断工具。PATHFAST生育标志物检测法在医师办公室实验室（POL）以及不孕症治疗期间的各种临床场所可能会有用。
