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A novel visual immunoassay for coeliac disease screening
J A Garrote1, L Sorell, P Alfonso
1Centro Nacional de Biotecnología, Madrid, Spain.
European Journal of Clinical Investigation
|August 24, 1999
Summary
A new visual immunoassay using Staphylococcus aureus protein A offers a simple, rapid, and cost-effective method for coeliac disease screening. This reliable test demonstrates high sensitivity and specificity, outperforming many enzyme-linked immunosorbent assay (ELISA) systems.
Area of Science:
- Immunology
- Gastroenterology
- Diagnostic Assays
Background:
- Current coeliac disease screening relies on indirect immunofluorescence and ELISA for antiendomysium and antigliadin antibodies.
- These methods necessitate parallel immunoassays to detect both IgG and IgA antibodies.
Purpose of the Study:
- To introduce a novel, simplified visual system for coeliac disease screening.
- To utilize Staphylococcus aureus protein A for detecting both IgG and IgA antibodies in a single assay.
Main Methods:
- A visual immunoassay was developed using microwell strips coated with wheat gliadin extract.
- Sera were incubated with protein A-colloidal gold conjugate, and results were determined by colorimetric comparison.
- The entire procedure was completed in under one hour.
Main Results:
- The assay was tested on 145 biopsy-proven sera (94 active coeliac, 51 controls).
- It achieved a sensitivity of 95.7% and a specificity of 94.1%.
- Ninety out of 94 active coeliac sera were positive, with only 3 of 51 non-coeliac controls showing positivity.
Conclusions:
- The visual system exhibits superior sensitivity and specificity compared to most ELISA systems.
- Its performance is comparable to IgA antiendomysium antibodies.
- The assay is inexpensive, rapid, simple to perform, easy to interpret, and requires no specialized personnel, making it ideal for reliable coeliac disease screening.