A first of its kind quantitative functional C1-esterase inhibitor lateral flow assay for hereditary angioedema point-of-care diagnostic testing
| Autor: | Priya S. Chockalingam, Stephen Fait, Hans Boehringer, Zhiwei Zhou, Roy B. Chung, Brijesh K. Garg |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Point-of-Care Systems Immunology Bradykinin C1-inhibitor 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Complement C1 medicine Humans Immunology and Allergy Point of care Pharmacology biology medicine.diagnostic_test business.industry Angioedemas Hereditary Diagnostic test Autosomal dominant trait bacterial infections and mycoses medicine.disease C1 esterase 030104 developmental biology Chromogenic Compounds chemistry 030220 oncology & carcinogenesis Immunoassay Mutation Hereditary angioedema biology.protein business Complement C1 Inhibitor Protein Protein Binding |
| Zdroj: | International Immunopharmacology. 83:106526 |
| ISSN: | 1567-5769 |
| DOI: | 10.1016/j.intimp.2020.106526 |
| Popis: | Hereditary Angioedema (HAE) is a rare, autosomal dominant disease caused by mutations in SERPING1 gene leading to dysfunction/deficiency of C1-esterase inhibitor (C1-INH) protein and subsequent dysregulation of the contact system and bradykinin overproduction. As functional C1-INH (fC1-INH) levels are reduced in HAE types I and II (HAE-I/II), a specific, sensitive and accessible rapid diagnostic method to quantitate fC1-INH is crucial in diagnosing HAE-I/II. Previously, we developed/validated methods to detect fC1-INH levels in human plasma based on functional binding to C1s or FXIIa for C1-INH-based therapies. Quantitative fC1-INH immunoassay methods were converted to the Lateral flow assay (LFA) platform after identifying the best reagent/s pair. The assay was developed and optimized as a first of its kind LFA method for quantifying fC1-INH in human plasma to aid HAE point-of-care diagnosis. Receiver operating characteristic analysis was performed using normal control and HAE subject plasma samples to calculate area-under-curve and a cut-off point to distinguish normal versus HAE subject samples. LFA data was correlated with the conventional diagnostic assay for fC1-INH in HAE plasma samples and profiles matched for individual subjects. Here, we demonstrate a proof-of-concept for the quantitative fC1-INH LFA using normal and HAE plasma samples. We propose that the method could be used as a point-of-care test to diagnose HAE in a variety of settings, such as, a hospital or physician's office, at home or in an ambulance. |
| Databáze: | OpenAIRE |
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