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一种常规酶学法与新的免疫化学发光法检测肾素的实验室内和实验室间重复性的比较研究。

A comparative study on inter and intralaboratory reproducibility of renin measurement with a conventional enzymatic method and a new chemiluminescent assay of immunoreactive renin.

机构信息

Department of Internal Medicine and Hypertension Center, San Giuseppe Hospital, University of Milan, Milan, Italy.

出版信息

J Hypertens. 2010 Jun;28(6):1307-12. doi: 10.1097/HJH.0b013e32833857ad.

Abstract

BACKGROUND

The activity of the renin-angiotensin system is usually evaluated as plasma renin activity (PRA, ngAI/ml per h) but the reproducibility of this enzymatic assay is notoriously scarce. We compared the inter and intralaboratory reproducibilities of PRA with those of a new automated chemiluminescent assay, which allows the direct quantification of immunoreactive renin [chemiluminescent immunoreactive renin (CLIR), microU/ml].

METHODS

Aliquots from six pool plasmas of patients with very low to very high PRA levels were measured in 12 centres with both the enzymatic and the direct assays. The same methods were applied to three control plasma preparations with known renin content.

RESULTS

In pool plasmas, mean PRA values ranged from 0.14 +/- 0.08 to 18.9 +/- 4.1 ngAI/ml per h, whereas those of CLIR ranged from 4.2 +/- 1.7 to 436 +/- 47 microU/ml. In control plasmas, mean values of PRA and of CLIR were always within the expected range. Overall, there was a significant correlation between the two methods (r = 0.73, P < 0.01). Similar correlations were found in plasmas subdivided in those with low, intermediate and high PRA. However, the coefficients of variation among laboratories found for PRA were always higher than those of CLIR, ranging from 59.4 to 17.1% for PRA, and from 41.0 to 10.7% for CLIR (P < 0.01). Also, the mean intralaboratory variability was higher for PRA than for CLIR, being respectively, 8.5 and 4.5% (P < 0.01).

CONCLUSION

The measurement of renin with the chemiluminescent method is a reliable alternative to PRA, having the advantage of a superior inter and intralaboratory reproducibility.

摘要

背景

肾素-血管紧张素系统的活性通常通过血浆肾素活性 (PRA,ngAI/ml per h) 进行评估,但这种酶联免疫测定的重现性很差。我们比较了 PRA 的 室间和室内重现性与新的自动化化学发光测定法的重现性,该方法允许直接定量免疫反应性肾素[化学发光免疫反应性肾素 (CLIR),微 U/ml]。

方法

将来自六份患者血浆样本的等分试样,这些患者的 PRA 水平非常低到非常高,用酶联免疫测定法和直接测定法在 12 个中心进行测量。相同的方法应用于三个具有已知肾素含量的对照血浆制剂。

结果

在血浆样本中,PRA 的平均值范围从 0.14 +/- 0.08 到 18.9 +/- 4.1 ngAI/ml per h,而 CLIR 的值范围从 4.2 +/- 1.7 到 436 +/- 47 microU/ml。在对照血浆中,PRA 和 CLIR 的平均值始终在预期范围内。总体而言,两种方法之间存在显著相关性 (r = 0.73,P < 0.01)。在按低、中、高 PRA 水平划分的血浆样本中也发现了类似的相关性。然而,实验室间发现的 PRA 变异系数始终高于 CLIR,范围从 59.4%到 17.1%,而 CLIR 的变异系数范围从 41.0%到 10.7% (P < 0.01)。此外,PRA 的平均实验室内部变异性高于 CLIR,分别为 8.5%和 4.5% (P < 0.01)。

结论

化学发光法测量肾素是 PRA 的可靠替代方法,具有更好的室间和室内重现性优势。

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