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Human chorionic gonadotropin discriminatory zone in ectopic pregnancy: does assay harmonization matter?
Diana Desai1, Jun Lu2, Sara P Wyness2
1Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah.
Fertility and Sterility
|March 27, 2014
Summary
Lack of human chorionic gonadotropin (hCG) assay harmonization significantly impacts results. However, a common hCG discriminatory zone of 1,500-3,500 IU/L is applicable across most common reagent platforms.
Area of Science:
- Clinical Chemistry
- Immunoassay Standardization
- Reproductive Endocrinology
Background:
- Human chorionic gonadotropin (hCG) assays are crucial for pregnancy monitoring.
- Lack of harmonization between different hCG assay platforms can lead to variable results.
- Interpretation of serum hCG concentrations relies on established discriminatory zones.
Purpose of the Study:
- To evaluate the impact of non-harmonized hCG assays on interpreting serum hCG concentrations.
- To assess the reliability of the hCG discriminatory zone across different immunoassay platforms.
Main Methods:
- A multisite method comparison study was conducted.
- Eighty serum samples with varying hCG concentrations were analyzed.
- Seven different hCG reagent platforms were used to measure hCG concentrations.
Main Results:
- Significant differences in hCG concentrations were observed across the seven reagent platforms.
- Seventy-one percent of assay pairs showed significant discrepancies, particularly between 1,500 and 3,500 IU/L.
- The calculated hCG discriminatory zones varied, with most assays within 9% of target values, but one assay showed a 40% deviation.
Conclusions:
- Despite inter-assay variability, a discriminatory zone of 1,500-3,500 IU/L for serum hCG is broadly applicable.
- One commonly used hCG reagent platform deviates significantly, necessitating careful interpretation.
