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KMID : 1101320040360010013
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Korean Journal of Clinical Laboratory Science
2004 Volume.36 No. 1 p.13 ~ p.18
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A Study of Reportable Range Setting through Concentrated Control Sample
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Chang Sang-Wu
Kim Nam-Yong
Choi Ho-Sung
Park Yong-Won
Yun Keun-Young
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Abstract
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This study was designed to establish working range for reoportable range in own laboratory in order to cover the upper and lower limits of the range in test method. We experimented ten times during 10 days for setting of reportable range with between run for method evaluation. It is generally assumed that the analytical method produces a linear response and that the test results between those upper and lower limits are then reportable. CLIA recommends that laboratories verify the reportable range of all moderate and high complexity tests. The Clinical Laboratory Improvement Amendments(CLIA) and Laboratory Accreditation Program of the Korean Society for Laboratory Medicine states reportable range is only required for "modified" moderately complex tests. Linearity requirements have been eliminated from the CLIA regulations and from others accreditation agencies, many inspectors continue to feel that linearity studies are a part of good lab practice and should be encouraged. It is important to assess the useful reportable range of a laboratory method, i.e., the lowest and highest test results that are reliable and can be reported. Manufacturers make claims for the reportable range of their methods by stating the upper and lower limits of the range. Instrument manufacturers state an operating range and a reportable range. The commercial linearity material can be used to verify this range, if it adequately covers the stated linear interval. CLIA requirements for quality control, must demonstrate that, prior to reporting patient test results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer. If applicable, the laboratory must also verify the reportable range of patient test results. The reportable range of patient test results is the range of test result values over which the laboratory can establish or verify the accuracy of the instrument, kit or test system measurement response. We need to define the usable reportable range of the method so that the experiments can be properly planned and valid data can be collected. The reportable range is usually defined as the range where the analytical response of the method is linear with respect to the concentration of the analyte being measured. In conclusion, experimental results on reportable range using concentrated control sample and zero calibrators covering from highest to lowest range were salicylate 8.8μg/dL, phenytoin 0.67μg/dL, phenobarbital 1.53μ g/dL, primidone 0.16μg/dL, theophylline 0.2μg/dL, vancomycine 1.3μg/dL, valproic acid 3.2μg/dL, digitoxin 0.17ng/dL, carbamazepine 0.36μg/dL and acetaminophen 0.7μg/dL at minimum level and salicylate 969.9μ g/dL, phenytoin 38.1μg/dL, phenobarbital 60.4μg/dL, primidone 24.57μg/dL, theophylline 39.2μg/dL, vancomycine 83.65μg/dL, valproic acid 147.96μg/dL, digitoxin 5.04ng/dL, carbamazepine 19.76μg/dL, acetaminophen 300.92μg/dL at maximum level.
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KEYWORD
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Reportable range, Test system, Good laboratory practice, Clinical Laboratory Improvement Amendments(CLIA)
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FullTexts / Linksout information
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Listed journal information
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