DIACON 정도관리물질의 평가

• 영문명: Evaluation of quality control, DIACON
• 발행기관: 대한핵의학기술학회
• 저자명: 김병찬(Byung Chan Kim) 정창기(Chang Gi Jung) 김상수(Sang Su Kim) 박혜미(Hae Mi Park) 김지선(Ji Sun Kim)
• 간행물 정보: 『핵의학기술』Vol.19 No.1, 44~50쪽, 전체 7쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2015.05.30

영문 초록

Purpose Quality control used in laboratory help to sustain precision and accuracy consistently to ensure the Diagnostic and treatment for medical employee. To perform an evaluation in statistical manner, it is recommended to use different quality control material than calibrator from manufacturer, quality control material must include analyzed concentration perimeter, must use more than two different concentration materials and recommended to use materials to indicate the concentration in clinical use. However, currently used quality control material has limit of evaluation due to unconsidered concentration or improperly used to get clinical importance data. Therefore, we compared the value of quality control, DIACON Hormone Level 1, 2, 3 (Scantibodies, USA) and DIACON Tumor Level 1, 2, 3 which applied to clinical concentration range. Materials and Methods DIACON Hormone Level 1, 2, 3 (Scantibodies, USA) and DIACON Tumor Level 1, 2, 3 (Scantibodies, USA) that used materials and methods test to compare the result from five RIA testing institution and one institution that used Elecsys (ROCHE) and Architect (ABOTT) for each level. The reagent RIA kit that used in this experiment is followed by Table 2 and 3. Test has performed by instruction itself and follow by instruction. Results Among DIACON hormone result of twenty four items, level 1 have three items, level 2 have four items and level 3 have five items were out of manufacturer set up range based on the average value. Among DIACON tumor result of thirteen items, level 1 have three items, level 2 have four items and level 3 have five items were out of manufacturer set up range. Other result were inside of manufacturer range. Conclusion For quality control material, it is widely available in market, but it is limited for normal range which is only concerned in improper clinical value and difficult to evaluate important concentration area in terms of clinical analyze. In this experiment, we evaluate Hormone twenty three items and Tumor thirteen items with DIACON Hormone and Tumor (Scantibodies, USA) to resolve this limit and we could observe that it ca be substituted and used.

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실험재료 및 방법

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키워드

quality control 정도관리 정도관리물질 DIACON