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牛血清淀粉样蛋白 A 的全自动免疫比浊分析性能评估。

Performance of an automated immunoturbidimetric assay for bovine serum amyloid A.

机构信息

Department of Veterinary Clinical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Frederiksberg C, Denmark.

出版信息

Vet Clin Pathol. 2024 Jun;53(2):229-233. doi: 10.1111/vcp.13355. Epub 2024 Jun 2.

Abstract

BACKGROUND

Acute phase proteins are a group of vital constituents of the innate immune system, which may also serve as circulatory biomarkers of inflammation. The major acute phase protein serum amyloid A (SAA) is a reliable and sensitive biomarker in cows, allowing for rapid detection of inflammatory disease. A multispecies automated immunoturbidimetric assay (VET-SAA, Eiken) has been validated for horses, dogs, and cats, and it has been used to measure SAA concentrations in bovine samples.

OBJECTIVES

The aim of the present study was to perform an analytical validation of the VET-SAA immunoturbidometric assay based on monoclonal antihuman SAA antibodies for the measurement of SAA in clinical samples from cows.

METHODS AND RESULTS

The validation included an assessment of imprecision, inaccuracy, and detection limit, as well as an evaluation of the overlap performance, using banked serum from healthy and sick cows with or without inflammatory disease. Intra- and interassay variation ranged from 0.91% to 2.9% and 2.5% to 5.8%, respectively. The assay was performed with acceptable accuracy within a clinically relevant range of SAA, although minor signs of inaccuracy were detected. Overlap performance was acceptable, with the VET-SAA assay able to differentiate between healthy cows and cows with inflammatory and noninflammatory conditions. The automated VET-SAA assay is considered acceptable for the measurement of SAA in cows.

摘要

背景

急性期蛋白是先天免疫系统的重要组成部分,也可以作为炎症的循环生物标志物。主要的急性期蛋白血清淀粉样蛋白 A(SAA)是牛的一种可靠且敏感的生物标志物,能够快速检测炎症性疾病。一种多物种自动化免疫比浊测定法(VET-SAA,Eiken)已经在马、狗和猫中得到验证,并已用于测量牛样品中的 SAA 浓度。

目的

本研究旨在对基于单克隆抗人 SAA 抗体的 VET-SAA 免疫比浊测定法进行分析验证,用于测量奶牛临床样本中的 SAA。

方法和结果

验证包括评估不精密度、不准确性和检测限,以及使用来自健康和患病牛的银行血清,评估重叠性能,这些牛有无炎症性疾病。批内和批间变异分别为 0.91%至 2.9%和 2.5%至 5.8%。该测定法在 SAA 的临床相关范围内具有可接受的准确性,尽管存在轻微的不准确性迹象。重叠性能可接受,VET-SAA 测定法能够区分健康牛和具有炎症和非炎症状况的牛。自动 VET-SAA 测定法被认为可用于测量奶牛的 SAA。

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