혈중 Estradiol 농도 측정을 위한 여러 방사면역측정 검사키트 및 화학면역발광 검사법의 성능평가 및 상호비교

• 영문명: Quality Assessment and Comparison of Several Radioimmunoassay Kits and Chemiluminescence Immunoassay Methods for Evaluating Serum Estradiol
• 발행기관: 대한핵의학기술학회
• 저자명: 최성희(Sung Hee Choi) 노경운(Gyeong Woon Noh) 김진의(Jin Eui Kim) 송요성(Yoo Sung Song) 팽진철(Jin Chul Paeng) 강건욱(Keon Wook Kang) 이동수(Dong Soo Lee)
• 간행물 정보: 『핵의학기술』Vol.19 No.1, 72~80쪽, 전체 9쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2015.05.30

영문 초록

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.

목차

서론

대상 및 방법

결과

고찰

결론

Acknowledgement

요약

참고문헌

키워드

Precision Accuracy Sensitivity Comparison External Quality Assurance Scheme