Performance evaluation of a laboratory‐developed light‐initiated chemiluminescence assay for quantification of egg white‐specific IgE

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(A)/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.