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用市售免疫分析法检测 724 例健康白种成年人胰岛素样生长因子-I 的特征和参考范围。

Characteristics and reference ranges of Insulin-Like Growth Factor-I measured with a commercially available immunoassay in 724 healthy adult Caucasians.

机构信息

Department of Endocrinology, Herlev Hospital, University of Copenhagen, Denmark.

出版信息

Scand J Clin Lab Invest. 2009;69(8):880-5. doi: 10.3109/00365510903165477.

Abstract

BACKGROUND AND OBJECTIVE

Measurements of Insulin-Like Growth Factor-I (IGF-I) play a pivotal role in the evaluation of the growth hormone-IGF-I axis. Due to assay variation IGF-I reference ranges are assay specific. We provide serum IGF-I reference ranges for adult men and women obtained by a commercially available assay.

METHOD

IGF-I was measured by an enzyme-linked immunosorbent assay (R&D Systems). Assay precision was evaluated in low, medium and high IGF-I pools and in single samples from outpatients. The reference ranges were obtained in 724 healthy Caucasians, mean age 48 years (range 19-91).

RESULTS

IGF-I was measured higher in serum compared to plasma samples (p<0.001, R2=0.96). To convert EDTA plasma values to serum values a factor of 1.22 was calculated. The intraassay coefficients of variation (CV) for the low: 56.4+/-2.7 ng/mL, medium: 179.7+/-5.9 ng/mL and high pool: 445.61+/-3.2 ng/mL (mean 1 SD) were 5, 3 and 3%. Interassays CVs for the low, medium and high pool varied between 7-10, 5-7, and 6-9%. Reproducibility between 4 different lots showed a intraclass CV of 0.99 (95%CI 0.98-0.96). Logarithmically transformed IGF-I levels were linearly associated with age with a 13% reduction in IGF-I per decade in females and 11% in males.

CONCLUSION

We have provided IGF-I reference ranges obtained by an assay that showed variations and reproducibility that was considered of sufficient high quality for clinical and scientific use.

摘要

背景与目的

胰岛素样生长因子-I(IGF-I)的测量在评估生长激素-IGF-I 轴中起着关键作用。由于测定方法的差异,IGF-I 的参考范围是特定于测定方法的。我们提供了通过商业上可用的测定法获得的成年男性和女性的血清 IGF-I 参考范围。

方法

IGF-I 通过酶联免疫吸附测定法(R&D Systems)进行测量。在低、中、高 IGF-I 池和门诊患者的单个样本中评估了测定方法的精密度。参考范围是在 724 名健康白种人中获得的,平均年龄为 48 岁(范围为 19-91 岁)。

结果

与血浆样本相比,IGF-I 在血清中测量值更高(p<0.001,R2=0.96)。为了将 EDTA 血浆值转换为血清值,计算出一个 1.22 的系数。低值的批内变异系数(CV)为 56.4+/-2.7ng/mL,中值为 179.7+/-5.9ng/mL,高值为 445.61+/-3.2ng/mL(均值 1 SD)分别为 5%、3%和 3%。低值、中值和高值的批间 CV 分别在 7-10%、5-7%和 6-9%之间变化。4 个不同批次之间的重复性显示出 0.99(95%CI 0.98-0.96)的组内 CV。经对数转换的 IGF-I 水平与年龄呈线性相关,女性 IGF-I 每十年降低 13%,男性降低 11%。

结论

我们提供了通过一种测定法获得的 IGF-I 参考范围,该测定法显示出足够高质量的变异和可重复性,可用于临床和科学用途。

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