Madersbacher S, Shu-Chen T, Schwarz S, Dirnhofer S, Wick G, Berger P
Institute for Biomedical Aging Research, Austrian Academy of Sciences, Innsbruck.
Clin Chem. 1993 Jul;39(7):1435-9.
The influence of assay design and quantification system on assay performance was investigated by developing, optimizing, and comparing a time-resolved immunofluorometric assay (IFMA), an immunoenzymometric assay (IEMA), an immunoradiometric assay (IRMA), and a competitive radioimmunoassay (RIA), all performed with the same monoclonal antibodies (MCA) directed against human follicle-stimulating hormone (hFSH). The lowest detection limit (2 ng/L for hFSH-I-3, corresponding to 2.5 mIU of 1st International Reference Preparation of hFSH 78/549 per liter), the widest measuring range (2-160,000 ng/L), and the greatest signal-to-noise ratio (13,000:1 at 160,000 ng/L) were obtained in the IFMA. For analysis of serum samples from 101 male (ages 2-91 years) and 99 female (ages 2-90 years) individuals at a single dilution, 100% of samples were within the measuring range of the IFMA, whereas only 87%, 55%, 32%, and 8% of the sera were for the IRMA, the IEMA evaluated with double-wavelength measurement, the conventional IEMA, and the competitive MCA-based RIA, respectively. These studies demonstrate clear advantages of the IFMA in sensitivity and assay range, which allows reliable and cost- and time-effective determination of hFSH in individuals from infancy to senescence.
通过开发、优化和比较时间分辨免疫荧光测定法（IFMA）、免疫酶测定法（IEMA）、免疫放射测定法（IRMA）和竞争性放射免疫测定法（RIA），研究了测定设计和定量系统对测定性能的影响，所有这些测定均使用针对人卵泡刺激素（hFSH）的相同单克隆抗体（MCA）进行。在IFMA中获得了最低检测限（hFSH-I-3为2 ng/L，相当于每升2.5 mIU的hFSH 78/549第一国际参考制剂）、最宽测量范围（2 - 160,000 ng/L）和最大信噪比（160,000 ng/L时为13,000:1）。对于来自101名男性（年龄2 - 91岁）和99名女性（年龄2 - 90岁）个体的血清样本在单一稀释度下的分析，100%的样本在IFMA的测量范围内，而对于IRMA、采用双波长测量评估的IEMA、传统IEMA和基于竞争性MCA的RIA，血清样本在测量范围内的比例分别仅为87%、55%、32%和8%。这些研究证明了IFMA在灵敏度和测定范围方面具有明显优势，这使得能够可靠且经济高效地测定从婴儿期到老年期个体中的hFSH。
