1. Establishment and performance evaluation of a chemiluminescence immunoassay for detecting Candida IgG antibody.
- Author
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LI Jingjing, WANG Xueqi, SUN Yashun, ZHAO Siqi, LIU Chunlong, and ZHONG Cheng
- Subjects
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CHEMILUMINESCENCE immunoassay , *IMMUNOGLOBULIN G , *COINCIDENCE , *CANDIDA , *POINT-of-care testing , *IMMUNOGLOBULINS , *GLUCOMANNAN - Abstract
Objective: To establish a method for Point of Care Testing detection Candida mannan IgG antibody based on chemiluminescence immunoassay. Methods: The candida mannan IgG antibody detection system was established according to the indirect method principle, and the analytical performance was evaluated according to the approved guidelines of the American Clinical Laboratory Standardization Association (CLSI). Results: Biotinylated Candida mannan antigen and Alkaline Phosphatase-labeled IgG antibody was successfully conjugated, and the optimal reaction concentration was 1 μg/ml. The limit of blank was 5.20 AU/ml. The limit of detection was 5.50 AU/ml. The precision and repeatability of CV were less than 10%. There was no cross reaction between the detection method and common specific antibodies. Hemoglobin, triglyceride and bilirubin had no significant effect on clinical samples. The overall coincidence rate between the detection method and ELISA were 90%, and the Kappa value=0.80, regression analysis and deviation analysis showed that the two methods had strong consistency (R²=0.989 8). Conclusion: The performance of the strip chemiluminescence detection system established in this study meets the relevant requirements of clinical auxiliary diagnostic technology, and is suitable for the rapid detection of Candida mannan IgG antibody in serum samples. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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