猫α-1-酸性糖蛋白酶联免疫吸附试验：性能特征和参考区间。

Cat alpha-1-acid glycoprotein enzyme-linked immunosorbent assay: performance characteristics and reference intervals.

机构信息

Clinic for Small Animals (Internal Medicine, Clinical Pathology and Clinical Pathophysiology), Justus-Liebig-University Giessen, Giessen, Germany.

出版信息

J Feline Med Surg. 2023 May;25(5):1098612X231162836. doi: 10.1177/1098612X231162836.

DOI:10.1177/1098612X231162836

PMID:37145170

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10811989/

Abstract

OBJECTIVES

The aim of this study was to evaluate performance of a feline-specific ELISA for the measurement of alpha-1-acid glycoprotein (AGP) and to establish a reference interval (RI).

METHODS

Surplus serum samples with low (~~200 µg/ml), medium (~~450 µg/ml) and high (~745 and 930 µg/ml) AGP concentrations were used to assess the intra- and inter-assay coefficients of variation (CVs). The quality goal for bioanalytical method validation was a CV of <20%. Linearity was assessed by serial dilution of a sample with a high AGP concentration. Spike recovery was evaluated by mixing samples with low, medium and high AGP concentrations at different ratios. To establish the RI, residual serum samples from 51 healthy adult cats that were presented for health examinations or blood donation between August 2020 and June 2021 were included.

RESULTS

The intra-assay CV was 8.5%, 4.3% and 4.0%, and the inter-assay CV was 18.8%, 15.5% and 11.5% for serum samples with low, medium and high AGP concentrations, respectively. Excellent linearity (R = 0.98) was demonstrated for AGP concentrations ranging between 251.6 and 954.4 µg/ml. Average recovery was 95.0-99.7%. The right-sided RI for AGP was 328 µg/ml (90% confidence interval 300-354). Age had a statistically significant impact (increasing values with older age, = 0.0026), but sex did not ( = 0.44), on AGP concentrations.

CONCLUSIONS AND RELEVANCE

The ELISA was accurate and showed acceptable precision with the modification of dilution used in this study. AGP concentrations in this population appeared to increase with increasing age.

摘要

目的

本研究旨在评估一种用于测量α-1-酸性糖蛋白（AGP）的猫科动物特异性 ELISA 的性能，并建立参考区间（RI）。

方法

使用低（~~200μg/ml）、中（~~450μg/ml）和高（~745 和 930μg/ml）AGP 浓度的剩余血清样本评估批内和批间变异系数（CV）。生物分析方法验证的质量目标是 CV<20%。通过对高 AGP 浓度的样本进行连续稀释来评估线性。通过将低、中、高 AGP 浓度的样本以不同比例混合来评估加标回收率。为了建立 RI，纳入了 2020 年 8 月至 2021 年 6 月期间因健康检查或献血而就诊的 51 只健康成年猫的剩余血清样本。

结果

低、中、高 AGP 浓度血清样本的批内 CV 分别为 8.5%、4.3%和 4.0%，批间 CV 分别为 18.8%、15.5%和 11.5%。AGP 浓度在 251.6 至 954.4μg/ml 之间具有极好的线性（R=0.98）。平均回收率为 95.0-99.7%。AGP 的右侧 RI 为 328μg/ml（90%置信区间 300-354）。年龄对 AGP 浓度有统计学显著影响（年龄越大，值越高，=0.0026），但性别无影响（=0.44）。