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Quality control study for estradiol receptor determination
Archiv Fur Geschwulstforschung
|January 1, 1985
Summary
Lyophilized calf uterine cytosol standards for estradiol receptor (ER) were prepared and validated. Storing these ER standards at 0-4 degrees C is recommended for reliable quality control in breast cancer clinical trials.
Area of Science:
- Endocrinology
- Biochemistry
- Clinical Chemistry
Background:
- Estradiol receptor (ER) quantification is crucial for breast cancer diagnosis and treatment.
- Standardized ER assays are essential for multicentric clinical trials.
- Calf uterine cytosol provides a viable source for ER standard preparation.
Purpose of the Study:
- To prepare and validate lyophilized calf uterine cytosol standards for ER.
- To assess the stability and reliability of these ER standards.
- To recommend optimal storage conditions for ER standards in quality control.
Main Methods:
- Lyophilization of calf uterine cytosol for ER standard preparation.
- Dextran-coated charcoal (DCC) technique with Scatchard analysis for ER binding capacity determination.
- Intra- and inter-assay variation assessment and dissociation constant (Kd) measurement.
Main Results:
- Lyophilized ER standards were successfully prepared in two institutes.
- Intra- and inter-assay coefficients of variation were 13.10% and 14.70%, respectively.
- ER standards demonstrated stability for several months when stored at -70°C or 0-4°C, but declined at ambient temperature.
Conclusions:
- Lyophilized calf uterine cytosol standards are suitable for ER quantification.
- Optimal storage at 0-4°C ensures ER standard stability for extended periods.
- These standards are recommended for inter-laboratory quality control in breast cancer clinical trials.