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一种用于测量牛心肌肌钙蛋白I的市售免疫测定法的验证

Validation of a commercially available immunoassay for the measurement of bovine cardiac troponin I.

作者信息

Varga A, Schober K E, Walker W L, Lakritz J, Michael Rings D

机构信息

Department of Veterinary Clinical Sciences, The Ohio State University, Columbus, OH, USA.

出版信息

J Vet Intern Med. 2009 Mar-Apr;23(2):359-65. doi: 10.1111/j.1939-1676.2009.0256.x. Epub 2009 Feb 3.

Abstract

BACKGROUND

Commercially available cardiac troponin I (cTnI) assays developed for use in humans have not yet been validated for use in cattle.

HYPOTHESES

The ADVIA Centaur TnI-Ultra immunoassay can be used for the detection of bovine cTnI. In healthy cattle, serum cTnI is undetectable or is present only in trace amounts.

METHODS

Purified bovine cTnI and cTnI-free bovine serum were used for the evaluation of assay performance including intra- and inter-assay precision, sensitivity, interference, linearity, and recovery. Effects of storage at 23, 4, -20, and -80 degrees C for 2 days, and at -20 and -80 degrees C for 7 and 14 days and repeated freeze-thaw cycles on recovery of cTnI were analyzed. Serum cTnI concentrations in 30 healthy dairy cows were determined.

RESULTS

Intra- and inter-assay precisions (mean +/- SD) were 4.48 +/- 2.26 and 13.36 +/- 6.59%, respectively. The assay demonstrated linearity at 0.5, 2, 15, and 30 ng/mL cTnI. Mean recovery was 100.81, 85.26, 87.72, and 114.42%, respectively. Skeletal muscle homogenate added to serum of known cTnI concentration did not alter the concentration of the analyte (P > .05). Concentration of cTnI significantly decreased when samples were stored at 4 and 23 degrees C for 2 days (P < .05). Repeated freeze-thaw cycles and storage at -20 degrees C for 7 days had no significant influence on cTnI concentration (P > .05). Serum cTnI concentration in healthy cattle was <or=0.03 ng/mL.

CONCLUSION AND CLINICAL IMPORTANCE

ADVIA Centaur can be used reliably for the detection of serum cTnI concentration in cattle.

摘要

背景

为人类使用而开发的市售心肌肌钙蛋白I(cTnI)检测方法尚未在牛身上得到验证。

假设

ADVIA Centaur TnI-Ultra免疫分析可用于检测牛cTnI。在健康牛中,血清cTnI检测不到或仅以微量存在。

方法

使用纯化的牛cTnI和不含cTnI的牛血清评估检测性能,包括批内和批间精密度、灵敏度、干扰、线性和回收率。分析了在23、4、-20和-80摄氏度下储存2天,以及在-20和-80摄氏度下储存7天和14天及反复冻融循环对cTnI回收率的影响。测定了30头健康奶牛的血清cTnI浓度。

结果

批内和批间精密度(均值±标准差)分别为4.48±2.26%和13.36±6.59%。该检测方法在cTnI浓度为0.5、2、15和30 ng/mL时显示出线性。平均回收率分别为100.81%、85.26%、87.72%和114.42%。向已知cTnI浓度的血清中添加骨骼肌匀浆不会改变分析物的浓度(P>.05)。当样品在4和23摄氏度下储存2天时,cTnI浓度显著降低(P<.05)。反复冻融循环和在-20摄氏度下储存7天对cTnI浓度无显著影响(P>.05)。健康牛的血清cTnI浓度≤0.03 ng/mL。

结论及临床意义

ADVIA Centaur可可靠地用于检测牛血清中的cTnI浓度。

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