analytical measuring interval set of values of quantities of the same kind that can be measured by a given measuring instrument or measuring system with specified instrumental measurement uncertainty, under defined conditions (JCGM 200:2012) NOTE 1: In some fields, the term is “analytical measurement range,” “measuring range,” or “measurement range” (modified from JCGM 200:2012); NOTE 2: The lower limit of a measuring interval should not be confused with “detection limit” (JCGM 200:2012); NOTE 3: This represents the interval of in vitro diagnostic examination results over which the performance characteristics of the in vitro diagnostic medical device were validated by the manufacturer; NOTE 4: Formerly, the terms “reportable range” or “measuring range” were used in CLSI documents; NOTE 5: The measuring interval over which the performance characteristics of an in vitro diagnostic medical device have been validated has been called the reportable range (ISO 18113-1); NOTE 6: For a discussion of the difference between interval and range, see A.2.11 (ISO 18113-1); NOTE 7: In the United States, the term often used is “analytical measuring range”; NOTE 8: In laboratory medicine, the term is defined as “measuring range,” or “analytical measurement range”; NOTE 9: The measuring interval is intended to refer to the interval of values that a measurement procedure can directly measure on the sample without any dilution, concentration, or other pretreatment not part of the usual measurement process; NOTE 10: The measuring interval has been called the analytical measurement range, reportable range, analytical range, and calibration range; NOTE 11: For EP05, the range of values (in units appropriate for the measurand) over which the acceptability criteria for the measurement procedure have been met; ie, the intersection of the linearity interval, the interval limited by the lower and upper limits of quantitation, and the interval representing acceptable imprecision; NOTE 12: The interval (or range) of values (in units appropriate for the analyte [measurand]) over which the acceptability criteria for the measurement procedure have been met; that is, where errors due to nonlinearity, imprecision, or other sources are within defined limits; NOTE 13: Formerly, the term “reportable range” was used in EP15, and another commonly used term is “analytical measurement range”; NOTE 14: The concentration range of results for which the measurement procedure functions to meet its intended use; NOTE 15: Measuring interval is determined by linearity, accuracy, and limit of detection; NOTE 16: The analytical measuring interval is the concentration value interval within which a given accuracy is achieved and a linear relationship between measurand values and the measurement procedure’s results is maintained with no preexamination dilution, concentration, or other pretreatment not part of the standard or routine measurement; NOTE 17: Although the terms “analytical measuring range” and “working interval” are commonly used instead of “analytical measuring interval,” their use is not encouraged; NOTE 18: This interval is separate from the extended measuring interval, within which preexamination dilutions are needed to obtain results; NOTE 19: It is sometimes called “analytical measurement range” or “measurement range,” which is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process; NOTE 20: The ability of a measurement procedure to detect small quantities of the analyte; NOTE 21: Analytical sensitivity is usually expressed as the “minimum detectable concentration” or “detection limit.” Alternate Term: working interval; measuring range; measuring interval; measurement interval Project: NBS11, I/LA21, ISO 18113-1, H26, POCT07, MM06, EP06, C51, EP17, C56, MM14, EP09, EP26, H60, VET04, C62, EP05, EP15, C57, MM03, MM23, POCT06, EP21, EP46, C24, EP34, C63, MM17, C34, C62, GP26, H26, EP39, EP35, NBS10 Related Term(s):
analytical measurement range
range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment, not part of the usual assay procedure
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measuring interval set of values of quantities of the same kind that can be measured by a given measuring instrument or measuring system with specified instrumental measurement uncertainty, under defined conditions (JCGM 200:2012) NOTE 1: The measuring interval is intended to refer to the interval of values that a measurement procedure can directly measure on the sample without any dilution, concentration, or other pretreatment not part of the usual measurement process; NOTE 2: The measuring interval has been called the analytical measurement range, analytical range, and calibration range; NOTE 3: The concentration range of results for which the test method functions to meet its intended use; NOTE 4: Measuring interval is determined by linearity, accuracy, and limit of detection; NOTE 5: This represents the interval of in vitro diagnostic examination results over which the performance characteristics of the in vitro diagnostic medical device were validated by the manufacturer; NOTE 6: The measuring interval over which the performance characteristics of an in vitro diagnostic medical device have been validated has been called the reportable range; NOTE 7: See reportable range. Project: ISO 17593, MM01, MM22, EP19, EP10
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