Performance evaluation of Eu3+-based CRP/SAA and PCT/IL-6 lateral flow immunoassay kits and their diagnostic value in respiratory tract infections

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-09-27 DOI:10.1016/j.plabm.2024.e00432

Mingxin Lin , Jing Zhang , Jianxing Cai , Jumei Liu , Min Zhu , Ke Li , Miaoyun Hu , Chenxi Li , Huiming Ye

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Abstract

Objectives

Respiratory infections are among the most common infectious diseases, resulting in significant morbidity and mortality. C-reactive protein (CRP), serum amyloid A (SAA), procalcitonin (PCT), and interleukin-6 (IL-6) are advantageous for diagnosing respiratory tract infections. This study assessed the analytical performance and accuracy of new kits for Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay and its diagnostic value in respiratory tract infections.

Methods

This study evaluated the detection performance of a test kit using guidelines from the Center for Medical Device Evaluation (CMDE) and the Clinical and Laboratory Standards Institute (CLSI). The test results were compared to those of the commercial kits (CRP: Mindray; SAA: Norman; PCT: Shanghai Upper; IL-6: Wantai BioPharm). A total of 156 patients with respiratory tract infections (53 with bacterial infections (Bac group); 50 with viral infections (Vir group); and 53 with co-infections (Bac + Vir group)) were enrolled, along with 50 healthy controls (HC group). Venous blood samples were collected to measure levels of SAA, PCT, CRP, and IL-6 using both the test and commercial kits. The diagnostic value of these biomarkers was assessed using receiver operating characteristic (ROC) curves.

Results

Correlation analysis demonstrated a strong concordance between the test kits and commercial kits (CRP: r = 0.9396, P < 0.0001; SAA: r = 0.8986, P < 0.0001; PCT: r = 0.9594, P < 0.0001; IL-6: r = 0.9009, P < 0.0001). The diagnostic performance of the test kits in identifying bacterial, viral, and co-infections was highly consistent with that of the commercial kit.

Conclusions

The Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay test kits demonstrated high levels of consistency with commercial kits in terms of quantitative outcomes and diagnostic performance for respiratory tract infections.

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基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒的性能评估及其在呼吸道感染中的诊断价值

目的呼吸道感染是最常见的传染病之一，会导致严重的发病率和死亡率。C反应蛋白（CRP）、血清淀粉样蛋白A（SAA）、降钙素原（PCT）和白细胞介素-6（IL-6）是诊断呼吸道感染的有利指标。本研究评估了基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定新试剂盒的分析性能和准确性及其在呼吸道感染中的诊断价值。检测结果与商用试剂盒（CRP：Mindray；SAA：Norman；PCT：Shanghai Upper；IL-6：Wantai BioPharm）的检测结果进行了比较。共招募了 156 名呼吸道感染患者（53 名细菌感染患者（Bac 组）；50 名病毒感染患者（Vir 组）；53 名合并感染患者（Bac + Vir 组））和 50 名健康对照组（HC 组）。采集静脉血样本，使用检测试剂盒和商业试剂盒测量 SAA、PCT、CRP 和 IL-6 的水平。结果相关性分析表明，检测试剂盒与商用试剂盒之间具有很强的一致性（CRP：r = 0.9396，P <；0.0001；SAA：r = 0.8986，P <；0.0001；PCT：r = 0.9594，P <；0.0001；IL-6：r = 0.9009，P <；0.0001）。结论基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒在呼吸道感染的定量结果和诊断性能方面与商业试剂盒具有高度的一致性。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.