공인된 기구에 의해 발급된 문서를 동반하는 인증표준물질은 특성값과 추정값의 신뢰정도를 나타내는 연계 불확도, 그리고 측정한 결과가 명시된 불확정 정도의 범위 내에서 국가 측정 또는 국제측정표준에 일치되도록 연속적으로 비교하고 교정하는 소급성을 제공하는 표준물질이다. 회수율 검사는 검체를 측정하여 얻은 값이 참값에서 얼마만큼 벗어났는지의 차이를 말하며 키트의 정확도를 반영한다. 이러한 인증표준물질을 가지고 회수율 검사를 하는 것은 체외 방사면역진단키트의 정확성을 보여주며 이러한 평가는 매우 중요하다. 인증표준물질은 NIBSC (National Institute for biological standard and control, United Kingdom)와 IRMM (Institute for Reference Materials and Measurements, Belgium)에서 구입하였고 검사 종목은 T4, Ferritin, PSA, Prolactin, AFP 그리고 TSH으로 총 6종목이다. T4는 IRMM의 표준물질을 사용하였고 나머지 종목은 NIBSC의 표준물질을 사용하였다. C-1 (저농도), C-2 (중농도), C-3 (고농도) 3 level로 제조하여 본원에서 사용하는 키트를 이용하여 4회 측정하였다. WHO 인증표준물질을 이용한 회수율 측정에서 T4 90%, Ferritin 88%, PSA 94%, Prolactin 99%, AFP 94%, TSH 93%였다. 6개 종목의 회수율 측정에서 88-99%로 양호한 결과를 보였다. 핵의학 체외진단키트의 정확성을 높이기 위해서 이 연구가 다른 검사실의 키트로 확장되어 검사가 되어야 하고 검사실간에도 교류가 필요하다. 인증표준물질을 이용한 체외진단키트의 회수율 평가가 앞으로도 지속되어야 하며 결과의 정확성은 환자의 만족의 증가로 이어질 것으로 기대한다.
공인된 기구에 의해 발급된 문서를 동반하는 인증표준물질은 특성값과 추정값의 신뢰정도를 나타내는 연계 불확도, 그리고 측정한 결과가 명시된 불확정 정도의 범위 내에서 국가 측정 또는 국제측정표준에 일치되도록 연속적으로 비교하고 교정하는 소급성을 제공하는 표준물질이다. 회수율 검사는 검체를 측정하여 얻은 값이 참값에서 얼마만큼 벗어났는지의 차이를 말하며 키트의 정확도를 반영한다. 이러한 인증표준물질을 가지고 회수율 검사를 하는 것은 체외 방사면역진단키트의 정확성을 보여주며 이러한 평가는 매우 중요하다. 인증표준물질은 NIBSC (National Institute for biological standard and control, United Kingdom)와 IRMM (Institute for Reference Materials and Measurements, Belgium)에서 구입하였고 검사 종목은 T4, Ferritin, PSA, Prolactin, AFP 그리고 TSH으로 총 6종목이다. T4는 IRMM의 표준물질을 사용하였고 나머지 종목은 NIBSC의 표준물질을 사용하였다. C-1 (저농도), C-2 (중농도), C-3 (고농도) 3 level로 제조하여 본원에서 사용하는 키트를 이용하여 4회 측정하였다. WHO 인증표준물질을 이용한 회수율 측정에서 T4 90%, Ferritin 88%, PSA 94%, Prolactin 99%, AFP 94%, TSH 93%였다. 6개 종목의 회수율 측정에서 88-99%로 양호한 결과를 보였다. 핵의학 체외진단키트의 정확성을 높이기 위해서 이 연구가 다른 검사실의 키트로 확장되어 검사가 되어야 하고 검사실간에도 교류가 필요하다. 인증표준물질을 이용한 체외진단키트의 회수율 평가가 앞으로도 지속되어야 하며 결과의 정확성은 환자의 만족의 증가로 이어질 것으로 기대한다.
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...
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.
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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문제 정의
Previously, cross institutional and modality experiments were performed using WHO certificated reference materials to assure accuracy of tests, however this study has focused on evaluating recovery of radioimmunoassay by WHO certificated reference materials. The purpose of this paper was to enhance reliability of in vitro diagnostic kit.
Previously, cross institutional and modality experiments were performed using WHO certificated reference materials to assure accuracy of tests, however this study has focused on evaluating recovery of radioimmunoassay by WHO certificated reference materials. The purpose of this paper was to enhance reliability of in vitro diagnostic kit.
대상 데이터
Thyroxine (T4), Ferritin, Prostate specific antigen(PSA), Prolactin, Alphafetoprotein (AFP) and Thyroid stimulating hormone (TSH) are the main items inspected at the in vitro lab of Department of Nuclear medicine. In this experiment, a total of 6 items was examined.
성능/효과
00, respectively, and 92%, 90% and 90% for recovery rate, respectively. Result of Recovery rate using WHO certified reference material was 90% (Table 2). Table 3 shows the results of the mean value, target value and recovery rate of C-1, C-2 and C-3.
Results of recovery rate using WHO Certified reference materials are T4 90%, Ferritin 88%, PSA 94%, Prolactin 99%, AFP 94% and TSH 93%. This demonstrates that the recovery rate went well.
41, respectively. Target values were 8.50, 15.00 and 25.00, respectively, and 92%, 90% and 90% for recovery rate, respectively. Result of Recovery rate using WHO certified reference material was 90% (Table 2).
후속연구
To further develop this study, it needs to expand more kits from other laboratories and institutes to increase accuracy and reliability results between each laboratory. It is necessary to continue examination of radioimmunoassay kits with Certified Reference Material.
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