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一种用于测量犬C反应蛋白的市售自动化犬特异性免疫比浊法的验证

Validation of a commercially available automated canine-specific immunoturbidimetric method for measuring canine C-reactive protein.

作者信息

Hillström Anna, Hagman Ragnvi, Tvedten Harold, Kjelgaard-Hansen Mads

机构信息

Department of Clinical Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.

出版信息

Vet Clin Pathol. 2014 Jun;43(2):235-43. doi: 10.1111/vcp.12150. Epub 2014 May 5.

Abstract

BACKGROUND

Measurement of C-reactive protein (CRP) is used for diagnosing and monitoring systemic inflammatory disease in canine patients. An automated human immunoturbidimetric assay has been validated for measuring canine CRP, but cross-reactivity with canine CRP is unpredictable.

OBJECTIVE

The purpose of the study was to validate a new automated canine-specific immunoturbidimetric CRP method (Gentian cCRP).

METHODS

Studies of imprecision, accuracy, prozone effect, interference, limit of quantification, and stability under different storage conditions were performed. The new method was compared with a human CRP assay previously validated for canine CRP determination. Samples from 40 healthy dogs were analyzed to establish a reference interval.

RESULTS

Total imprecision was < 2.4% for 4 tested serum pools analyzed twice daily over 10 days. The method was linear under dilution, and no prozone effect was detected at a concentration of 1200 mg/L. Recovery after spiking serum with purified canine CRP at 2 different concentrations was 123% and 116%, respectively. No interference from hemoglobin or triglycerides (10 g/L) was detected. CRP was stable for 14 days at 4°C and 22°C. In the method comparison study, there was good agreement between the validated human CRP assay and the new canine-specific assay. Healthy dogs had CRP concentrations that were less than the limit of quantification of the Gentian cCRP method (6.8 mg/L).

CONCLUSIONS

The new canine-specific immunoturbidimetric CRP assay is a reliable and rapid method for measuring canine CRP, suitable for clinical use due to the option for an automated assay.

摘要

背景

C反应蛋白(CRP)的检测用于犬类患者全身炎症性疾病的诊断和监测。一种自动化的人类免疫比浊法已被验证可用于检测犬类CRP,但与犬类CRP的交叉反应性不可预测。

目的

本研究的目的是验证一种新的自动化犬特异性免疫比浊法CRP方法(龙胆cCRP)。

方法

进行了不精密度、准确性、前带效应、干扰、定量限和不同储存条件下稳定性的研究。将新方法与先前验证用于犬类CRP测定的人类CRP检测方法进行比较。分析了40只健康犬的样本以建立参考区间。

结果

在10天内每天对4个测试血清池进行两次分析,总不精密度<2.4%。该方法在稀释下呈线性,在浓度为1200mg/L时未检测到前带效应。在血清中加入两种不同浓度的纯化犬类CRP后的回收率分别为123%和116%。未检测到血红蛋白或甘油三酯(10g/L)的干扰。CRP在4°C和22°C下可稳定保存14天。在方法比较研究中,经过验证的人类CRP检测方法与新的犬特异性检测方法之间具有良好的一致性。健康犬的CRP浓度低于龙胆cCRP方法的定量限(6.8mg/L)。

结论

新的犬特异性免疫比浊法CRP检测是一种可靠且快速的检测犬类CRP的方法,由于可选择自动化检测,适用于临床应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c840/4257579/99cedfa18627/vcp0043-0235-f1.jpg

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