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Are laboratories reporting serum quantitative hCG results correctly?
1Division of Molecular Medicine, Wadsworth Center for Laboratories and Research, New York State Department of Health, Albany, NY 12201-0509, USA. tim@wadsworth.org
Clinical Chemistry
|April 1, 2008
Summary
Laboratory errors in reporting human chorionic gonadotropin (hCG) forms are common. Misidentification of intact hCG and total beta hCG by clinical labs highlights the need for improved assay specificity and clear nomenclature for accurate patient diagnosis.
Area of Science:
- Clinical Chemistry
- Endocrinology
- Laboratory Medicine
Background:
- Human chorionic gonadotropin (hCG) is a vital hormone with multiple forms, including intact hCG, total beta hCG, and hCG free beta-subunit.
- Accurate measurement of hCG forms is crucial for pregnancy confirmation, monitoring, trophoblastic disease diagnosis, and prenatal screening.
Purpose of the Study:
- To assess the accuracy of reporting various human chorionic gonadotropin (hCG) forms in clinical laboratories.
- To identify common errors in the quantification and reporting of intact hCG and total beta hCG.
Main Methods:
- Prepared human serum samples spiked with known concentrations of intact hCG and hCG free beta-subunit.
- Distributed samples to participating laboratories for analysis using their routine immunoassay methods.
Main Results:
- Significant reporting errors were observed: 9.3% of labs misreported intact hCG as total beta hCG.
- Additionally, 13.1% of labs incorrectly reported total beta hCG as intact hCG.
Conclusions:
- Errors stem from the complex nature of hCG, confusing nomenclature, and lack of personnel awareness regarding assay specificities.
- Ambiguous reagent labeling and insufficient information on assay specificity in product inserts contribute to misreporting.
- Standardization of nomenclature and improved assay clarity are essential for accurate hCG testing.
