대한임상검사과학회지 (Korean Journal of Clinical Laboratory Science)
- 제38권2호
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- Pages.117-124
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- 2006
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- 1738-3544(pISSN)
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- 2288-1662(eISSN)
분석측정범위의 실증적 평가
An Empirical Study of the Analytical Measurement Range in Clinical Chemistry
- 장상우 (녹십자의료재단, 고객지원 및 QA부) ;
- 이상곤 (녹십자의료재단, 화학혈액 검사실) ;
- 김영환 (녹십자의료재단, 고객지원 및 QA부) ;
- 송은영 (녹십자의료재단, 면역검사실) ;
- 박용원 (녹십자의료재단, 화학혈액 검사실) ;
- 박병옥 (녹십자의료재단, 화학혈액 검사실) ;
- 류재기 (김천보건대학, 임상병리과)
- Chang, Sang-Wu (Technical Informaton & QA Division, Green Cross Reference Laboratories) ;
- Lee, Sang-Gon (Department of Clinical Chemistry, Green Cross Reference Laboratories) ;
- Kim, Young-Hwan (Technical Informaton & QA Division, Green Cross Reference Laboratories) ;
- Song, Eun-Young (Department of Immunology, Green Cross Reference Laboratories) ;
- Park, Yong-Won (Department of Clinical Chemistry, Green Cross Reference Laboratories) ;
- Park, Byong-Ok (Department of Clinical Chemistry, Green Cross Reference Laboratories) ;
- Lyu, Jae-Gi (Department of Biomedical Laboratory Science, Gimcheon College)
- 발행 : 2006.08.31
초록
The analytical measurement range (AMR) is the range of analyte values that a method can directly measure on a specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. The linearity of the AMR is its ability to obtain test results which are directly proportional to the concentration of analyte in the sample from the upper and lower limit of the AMR. The AMR validation is the process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The test specimen must have analyte values which, at a minimum, are near the low, midpoint, and high values of the AMR. The AMR must be revalidated at least every six months, at changes in major system components, and when a complete change in reagents for a procesure is introduced; unless the laboratory can demonstrate that changing the reagent lot number does not affect the range used to report patient test results. The AMR linearity was total protein (0-16.6), albumin (0-8.1), total bilirubin (0-18.1), alkaline phosphatase (0-1244.3), aspartate aminotransferase (0-1527.9), alanine aminotransferase (0-1107.9), gamma glutamyl transpeptidase (0-1527.7), creatine kinase (0-1666.6), lactate dehydrogenase (0-1342), high density lipoprotein cholesterol (0.3-154.3), sodium (35.4-309), creatinine (0-19.2), blood urea nitrogen (0.5-206.2), uric acid (0-23.9), total cholesterol (-0.3-510), triglycerides (0.7-539.6), glucose (0-672.7), amylase (0-1595.3), calcium (0-23.9), inorganic phosphorus (0.03-17.0), potassium (0.1-116.5), chloride (3.3-278.7). We are sure that materials for the AMR affect the evaluation of the upper limit of the AMR in the process system.