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KMID : 1143620140180010158
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Korean Journal of Nuclear Medicine Technology
2014 Volume.18 No. 1 p.158 ~ p.162
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The Evaluation of Recovery Rate of Radioimmunoassay Using Certified Reference Material (CRM)
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Choi Sung-Hee
Shin Sun-Young
Lim So-Hee
Hong Mee-Kyoung
Noh Kyeong-Woon
Kim Jin-Eui
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Abstract
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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.
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KEYWORD
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CRM, RM, Retroactivity, Uncertainty, Recovery, Accuracy
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