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KMID : 1143620150190010072
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Korean Journal of Nuclear Medicine Technology
2015 Volume.19 No. 1 p.72 ~ p.80
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Quality Assessment and Comparison of Several Radioimmunoassay Kits and Chemiluminescence Immunoassay Methods for Evaluating Serum Estradiol
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Choi Sung-Hee
Noh Kyeong-Woon
Kim Jin-Eui
Song Yoo-Sung
Paeng Jin-Chul
Kang Keon-Wook
Lee Dong-Soo
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Abstract
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Purpose : Serum estradiol (E2) measurement is requested for diagnosing menstrual cycles, ovulation induction, infertility,
and menopause. E2 is measured using several methods and kits including radioimmunoassay (RIA) and
chemiluminescece immunoassay (CLIA). The purpose of this study was to evaluate quality of these methods
and to compare them with each other.
Materials and Methods : Seven radioimmunoassay kits and two CLIA methods were included in the analysis. Using standard samples and patient samples, intra-assay precision, inter-assay precision, correlation between other methods, sensitivity, and recovery rate were evaluated.
Results : For all tested kits and methods, coefficients of variance (CVs) of intra-assay precision test were 10.9~13.6% in low-level samples and less than 10% in medium and high-level samples. CVs of inter-assay precision test were 10.8~12.3% in low-level samples and less than 10% in medium and high-level samples with all tested kits and methods. Recovery rates were 92.7±12.4% for SIEMENS, 101.4±18.4% for DIAsource, 95.1±11.5% for AMP, 108.4±18.5% for BECKMAN COULTER, 104.2±13.5% for BECKMAN COULTER Ultra Sensitive, 101.3±11.6% for CIS Bio, and 93.1±13.2% for MP kits. Sensitivity was 7.5, 6.2, 5.7, 6.2, 5.3, 4.5, and 5.5 pg/mL for SIEMENS, DIAsource, AMP, BECKMAN COULTER, BECKMAN COULTER Ultra Sensitive, CIS Bio, and MP kits, respectively. The measurement by MP kit was slightly higher than those by other kits in low-level samples, and the measurement by E170 was slightly higher than those of other kits in medium and high-level samples. In the measurement of standard sample for external quality control, SIEMENS kit produced relatively lower values whereas E170, Architect, and MP kits produced relatively higher values compared with other kits.
Conclusion : All tested kits for E2 measurement have satisfactory performance for clinical use. However, correlation between kits should be considered when test kits are to be changed, because some pairs of kits do not have correlations
with each other.
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KEYWORD
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Precision, Accuracy, Sensitivity, Comparison, External Quality Assurance Scheme
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