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RISS 인기검색어
- 검색키워드
- 저자 : W. Greg Miller (검색결과 3 건)
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Harmonization: the Sample, the Measurement, and the Report
W. Greg Miller,Jillian R. Tate,Julian H. Barth,Graham R. D. Jones 대한진단검사의학회 2014 Annals of Laboratory Medicine Vol.34 No.3
Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made. Har- monization of test results includes consideration of pre-analytical, analytical, and post-ana- lytical aspects. Progress has been made in each of these aspects, but there is currently poor coordination of the effort among different professional organizations in different coun- tries. Pre-analytical considerations include terminology for the order, instructions for prepa- ration of the patient, collection of the samples, and handling and transportation of the sam- ples to the laboratory. Key analytical considerations include calibration traceability to a ref- erence system, commutability of reference materials used in a traceability scheme, and specificity of the measurement of the biomolecule of interest. International organizations addressing harmonization include the International Federation for Clinical Chemistry and Laboratory Medicine, the World Health Organization, and the recently formed International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR). The ICHCLR will provide a prioritization process for measurands and a service to coordinate global harmoni- zation activities to avoid duplication of effort. Post-analytical considerations include nomen- clature, units, significant figures, and reference intervals or decision values for results. Har- monization in all of these areas is necessary for optimal laboratory service. This review summarizes the status of harmonization in each of these areas and describes activities un- derway to achieve the goal of fully harmonized clinical laboratory testing.
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W. Greg Miller,Gary L. Myers,Mary Lou Gantzer,Stephen E. Kahn,E. Ralf Schönbrunner,Linda M. Thienpont,David M. Bunk,Robert H. Christenson,John H. Eckfeldt,Stanley F. Lo,C. Micha Nübling,Catharine M. S 대한진단검사의학회 2012 Laboratory Medicine Online Vol.2 No.1
Results between different clinical laboratory measurement procedures (CLMP) should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. When laboratory test results are neither standardized nor harmonized, a different numeric result may be obtained for the same clinical sample. Unfortunately, some guidelines are based on test results from a specific laboratory measurement procedure without consideration of the possibility or likelihood of differences between various procedures. When this happens, aggregation of data from different clinical research investigations and development of appropriate clinical practice guidelines will be flawed. A lack of recognition that results are neither standardized nor harmonized may lead to erroneous clinical, financial, regulatory, or technical decisions. Standardization of CLMPs has been accomplished for several measurands for which primary (pure substance) reference materials exist and/or reference measurement procedures (RMPs) have been developed. However, the harmonization of clinical laboratory procedures for measurands that do not have RMPs has been problematic owing to inadequate definition of the measurand, inadequate analytical specificity for the measurand,inadequate attention to the commutability of reference materials, and lack of a systematic approach for harmonization. To address these problems,an infrastructure must be developed to enable a systematic approach for identification and prioritization of measurands to be harmonized on the basis of clinical importance and technical feasibility, and for management of the technical implementation of a harmonization process for a specific measurand.
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이상지혈증 환자군의 심혈관 질환 위험 등급의 분류에서 LDL콜레스테롤 측정치 혹은 계산치보다 Non-HDL 콜레스테롤이 더 정확하다
Hendrick E. van Deventer,W. Greg Miller,Gary L. Myers,Ikunosuke Sakurabayashi,Lorin M. Bachmann,Samuel P. Caudill,Andrzej Dziekonski,Selvin Edwards,Mary M. Kimberly,William J. Korzun,Elizabeth T. Lear 대한진단검사의학회 2011 Laboratory Medicine Online Vol.1 No.3
Background: Our objective was to evaluate the accuracy of cardiovascular disease (CVD) risk score classification by direct LDL cholesterol (dLDL-C), calculated LDL cholesterol (cLDL-C), and non–HDL cholesterol (non–HDL-C) compared to classification by reference measurement procedures (RMPs) performed at the CDC. Methods: Weexamined 175 individuals, including 138 with CVD or conditions that may affect LDL-C measurement. dLDL-C measurements were performed using Denka, Kyowa, Sekisui, Serotec, Sysmex, UMA, and Wako reagents. cLDL-C was calculated by the Friedewald equation, using each manufacturer’s direct HDL-C assay measurements, and total cholesterol and triglyceride measurements by Roche and Siemens (Advia) assays,respectively. Results: For participants with triglycerides <2.26 mmol/L (<200 mg/dL), the overall misclassification rate for the CVD risk score ranged from 5% to 17% for cLDL-C methods and 8% to 26% for dLDL-C methods when compared to the RMP. Only Wako dLDL-C had fewer misclassifications than its corresponding cLDL-C method (8% vs 17%; P <0.05). Non–HDL-C assays misclassified fewer patients than dLDL-C for 4 of 8 methods (P <0.05). For participants with triglycerides ≥2.26 mmol/L (≥200 mg/dL) and <4.52 mmol/L (<400 mg/dL), dLDL-C methods, in general, performed better than cLDL-C methods, and non–HDL-C methods showed better correspondence to the RMP for CVD risk score than either dLDL-C or cLDL-C methods. Conclusions: Except for hypertriglyceridemic individuals, 7 of 8 dLDL-C methods failed to show improved CVD risk score classification over the corresponding cLDL-C methods. Non–HDL-C showed overall the best concordance with the RMP for CVD risk score classification of both normal and hypertriglyceridemic individuals.
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