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Enzyme immunoassay for human chorionic gonadotropin and its clinical application
Acta Obstetrica Et Gynaecologica Japonica
|July 1, 1981
Summary
A new enzyme immunoassay (EIA) for human chorionic gonadotropin (hCG) has been developed, replacing radioisotopes with enzymes for safer and more accessible testing. This assay is effective for various gynecological and obstetrical diagnoses.
Area of Science:
- Biochemistry
- Immunology
- Clinical Chemistry
Background:
- Radioisotope-based assays like RIA and RRA for human chorionic gonadotropin (hCG) have limitations due to radioisotope use.
- Enzyme immunoassays (EIA) offer a safer alternative, utilizing stable enzymes for labeling with no adverse effects on humans.
Purpose of the Study:
- To develop and validate a novel enzyme immunoassay (EIA) for human chorionic gonadotropin (hCG).
- To establish a safer, more accessible, and clinically applicable assay for hCG detection.
Main Methods:
- Developed a sequential competitive EIA for hCG utilizing beta-D-Galactosidase (beta-Gal) as the labeling enzyme.
- Employed a conjugating agent (MCAE) to prevent self-coupling and used silicone rods as the solid phase for easier handling.
- Implemented a method to remove serum interference, enabling measurement within 12 hours.
Main Results:
- The developed EIA can measure hCG levels ranging from 0.5 mIU/ml to 200 mIU/ml within 12 hours.
- The assay demonstrated satisfactory coefficients of variation, indicating good reproducibility.
- The assay has been clinically applied in diagnosing brain metastasis of trophoblastic disease, early pregnancy diagnosis, and prognosis of threatened abortion.
Conclusions:
- The newly developed EIA for hCG is a sensitive, stable, and clinically useful diagnostic tool.
- This enzyme-based assay overcomes the limitations of radioisotope methods, offering broader applicability in obstetrics and gynecology.
- Further clinical trials are underway for its use in the follow-up of trophoblastic disease.