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KMID : 1143620150190010044
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Korean Journal of Nuclear Medicine Technology
2015 Volume.19 No. 1 p.44 ~ p.50
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Evaluation of quality control, DIACON
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Kim Byung-Chan
Jung Chang-Gi
Kim Sang-Su
Park Hae-Mi
Kim Ji-Sun
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Abstract
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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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KEYWORD
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quality control, DIACON
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