实验室研发的光引发化学发光法用于定量检测蛋清特异性 IgE 的性能评估。
Performance evaluation of a laboratory-developed light-initiated chemiluminescence assay for quantification of egg white-specific IgE.
机构信息
School of Medical Laboratory, Tianjin Medical University, Tianjin, China.
Department of Clinical Laboratory, Tianjin Children's Hospital, Tianjin University, Tianjin, China.
出版信息
J Clin Lab Anal. 2022 Jul;36(7):e24544. doi: 10.1002/jcla.24544. Epub 2022 Jun 16.
BACKGROUND
Specific IgE (sIgE) testing has become one of the most important tools for diagnosing IgE-mediated food allergy. Enzyme-linked immunosorbent assay (ELISA) and dot-enzyme-linked immunosorbent assay (Dot-ELISA) have been used to measure sIgE in clinical widely. Light-initiated chemiluminescence assay (LICA) is a new method for measuring allergen-sIgE. We aimed to establish a LICA method for quantitative detection of egg white-sIgE and evaluate its performances.
METHODS
The best chemibeads coupling method in detecting egg white-sIgE was selected, and a LICA method for quantitative detection of egg white-sIgE was established. The precision study was performed according to Clinical and Laboratory Standards Institute (CLSI) EP5-A2. Detection capability which contains limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) was evaluated according to National Health Commission of the People's Republic of China (NHC) WS/T 514-2017. Linear range was evaluated according to CLSI EP6-A. All data were analyzed using SPSS software.
RESULTS
Precision contains repeatability and intermediate precision. The CV of repeatability ranged from 2.72% to 7.29%, and the CV of intermediate precision ranged from 4.93% to 8.64%. The LoB, LoD, and LoQ of the assay were 0.000 kUA/L, 0.053 kUA/L, and 0.076 kUA/L. The assay linear range was 0.076-34.125 kU /L (r = 0.9979 ≥ 0.9900).
CONCLUSION
This laboratory-developed LICA method can detect egg white-sIgE, and performance meets clinical requirements. This method shows rapid turnaround cycles and high sensitivity. It can be used as an alternative method for clinical detection of egg white-sIgE.
背景
特异性 IgE（sIgE）检测已成为诊断 IgE 介导的食物过敏的最重要工具之一。酶联免疫吸附试验（ELISA）和斑点酶联免疫吸附试验（Dot-ELISA）已广泛用于临床检测 sIgE。光引发化学发光测定法（LICA）是一种新的测量过敏原-sIgE 的方法。我们旨在建立一种用于定量检测蛋清-sIgE 的 LICA 方法，并评估其性能。
方法
选择了用于检测蛋清-sIgE 的最佳 chemibead 偶联方法，并建立了一种用于定量检测蛋清-sIgE 的 LICA 方法。根据临床和实验室标准协会（CLSI）EP5-A2 进行了精密度研究。根据国家卫生健康委员会（NHC）WS/T 514-2017 评估了检测能力，其中包含空白限（LoB）、检测限（LoD）和定量限（LoQ）。根据 CLSI EP6-A 评估了线性范围。所有数据均使用 SPSS 软件进行分析。
结果
精密度包含重复性和中间精密度。重复性的 CV 范围为 2.72%至 7.29%，中间精密度的 CV 范围为 4.93%至 8.64%。该测定的 LoB、LoD 和 LoQ 分别为 0.000 kUA/L、0.053 kUA/L 和 0.076 kUA/L。该测定的线性范围为 0.076-34.125 kU/L（r=0.9979≥0.9900）。
结论
本实验室开发的 LICA 方法可检测蛋清-sIgE，性能符合临床要求。该方法具有快速周转周期和高灵敏度，可作为临床检测蛋清-sIgE 的替代方法。
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