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Two-site immunochemiluminometric assay for human alpha 1-fetoprotein.
Clinical Chemistry
|August 1, 1983
Summary
This study introduces a new assay for alpha 1-fetoprotein (AFP) using acridinium ester-labeled antibodies. The assay demonstrates high sensitivity and accuracy, comparable to radioimmunoassay, for measuring AFP in pregnant women.
Area of Science:
- Biochemistry
- Immunology
- Analytical Chemistry
Background:
- Alpha 1-fetoprotein (AFP) is a crucial biomarker in prenatal diagnostics and cancer screening.
- Existing assays for AFP may have limitations in sensitivity or require complex procedures.
Purpose of the Study:
- To develop and validate a novel two-site immunochemiluminometric assay for human alpha 1-fetoprotein (AFP).
- To evaluate the assay's sensitivity, working range, and agreement with conventional methods.
Main Methods:
- Utilized acridinium ester-labeled monoclonal antibodies and sheep anti-AFP IgG immobilized on aminoaryl cellulose.
- Employed a simultaneous incubation of labeled and solid-phase antibodies followed by a short quantification time.
- Investigated the impact of acridinium ester incorporation ratio on assay sensitivity.
Main Results:
- The assay achieved a working range of 20-246 kilo-int. units/L with CVs ≤10%.
- Demonstrated a high sensitivity of detection at 1.3 kilo-int. units/L.
- AFP concentrations in pregnant women's sera correlated well with results from a conventional radioimmunoassay.
Conclusions:
- The developed immunochemiluminometric assay is a sensitive and reliable method for quantifying human AFP.
- Increased specific activity of labeled antibodies enhances assay sensitivity.
- This assay offers a viable alternative to radioimmunoassay for AFP measurement in clinical settings.