인증표준물질(CRM)을 이용한 방사면역측정법의 회수율 평가

• 영문명: The Evaluation of Recovery Rate of Radioimmunoassay Using Certified Reference Material (CRM)
• 발행기관: 대한핵의학기술학회
• 저자명: 최성희(Sung Hee Choi) 신선영(Sun Young Shin) 임소희(So Hee Lim) 홍미경(Mee Kyung Hong) 노경운(Gyeong Woon Noh) 김진의(Jin Eui Kim)
• 간행물 정보: 『핵의학기술』Vol.18 No.1, 158~162쪽, 전체 5쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2014.05.30

영문 초록

Purpose: Reference material (RM) is defined as material that is safe and homogeneous enough about specified characteristic that is made with a purpose of using test of measurement or nominal characteristic. Certified reference material (CRM), which is issued by authorized organization, is defined as reference material that provides characteristic value, link uncertainty and retroactivity. The purpose of this paper was to evaluate recovery of radioimmunoassay by Certified Reference Material enclosed with a certificate and therefore to enhance reliability of test. Materials and Methods: WHO certified reference material is purchased from NIBSC (National Institute for Biological Standard and Control, United Kingdom) and made of 3 levels that are C-1 (low concentration), C-2 (medium concentration) and C-3 (high concentration) and measured for kit at the Seoul National University Hospital. Recovery rate is evaluated after measurement at four different days. Results: Recovery rate results using WHO certified reference material are T4 90%, Ferritin 88%, PSA 94%, Prolactin 99%, AFP 94% and TSH 93%. Conclusion: A procedure that appropriate accuracy, precision, specificity, sensitivity, reproducibility, and validate on the subject of kit for radioimmunoassay is essential. Recovery rate assay as extraction efficiency of analysis process is percent about already measuring results of analysis result after all measuring process. This is very important assessment standards of performance evaluation of immunoassay kit. Recovery rate results of 6 type used WHO CRM are satisfactory to 88~99%. This demonstrates that the radioimmunoassay is a very accurate measurement, which is very effectively utilized in clinical practice.

목차

INTRODUCTION

MATERIALS AND METHODS

Results

Discussion and Conclusion

SUMMARY

REFERENCES

키워드

CRM RM Retroactivity Uncertainty Recovery Accuracy