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Development and validation of a fluorescent microsphere immunoassay for soluble CD30 testing
Igor Pavlov1, Thomas B Martins, Julio C Delgado
1ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA. igor.pavlov@aruplab.com
Clinical and Vaccine Immunology : CVI
|July 17, 2009
Summary
A new fluorescent microsphere immunoassay accurately detects soluble CD30 (sCD30), a key Th2 immune response marker. This assay shows high precision and sensitivity, proving useful for diagnosing immunological and inflammatory diseases.
Area of Science:
- Immunology
- Biochemistry
- Assay Development
Background:
- Soluble CD30 (sCD30) is a prognostic marker for Th2 immune responses.
- sCD30 is relevant in transplantation, lymphoproliferative disorders, autoimmunity, and parasitic diseases.
Purpose of the Study:
- To develop and validate a fluorescent microsphere immunoassay for sCD30 detection.
- To assess the assay's performance and clinical utility.
Main Methods:
- Development of a fluorescent microsphere immunoassay.
- Validation using serum, plasma, and culture supernatants.
- Testing with recombinant sCD30 and clinical samples.
Main Results:
- Assay dynamic range: 1-400 ng/ml.
- High precision (CVs ≤8%) and sensitivity (1 ng/ml).
- Normal reference range: 1-29 ng/ml in 151 healthy individuals.
- Positive correlation with anti-dsDNA antibodies and anti-Leishmania IgG.
Conclusions:
- The fluorescent microsphere immunoassay is a precise and sensitive method for sCD30 quantification.
- sCD30 testing is clinically useful for immunological and inflammatory diseases with Th2 responses.
- Multiplexing potential suggests future diagnostic applications for sCD30 and other cytokines.

