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Глоссарий по стандартизации, контролю и управлению качеством

  1. Measured portion of a whole having the same composition. general term referring to part of a solution, sample, mixture, etc.

  2. A part of a larger thing, especially a sample of somethi...
  1. The substance to be measured. clsi recommends using the term “measurand” “for a particular quantity subject to measurement.”

  2. A substance measured in the laboratory. a chemical for w... вещество;
analytical error
    Difference between the estimated value of a quantity and its true value. this difference (positive or negative) may be expressed either in the units in which the quantity is measured, or as a perc...
analytical quality assurance (aqa)
    Used with charts of operating specifications (opspecs charts) to indicate the level of assurance for detecting critical sized errors. for example, 90% aqa(se) means there will be at least a 90% ch...
analytical quality requirement
    Used here to refer to a quality requirement in the form of an allowable total error (tea). often defined on the basis of proficiency testing criteria for acceptable performance, such as the clia r...
analytical run
    Generally defined by clia as an 8 hour to 24 hour interval during which control materials must be analyzed. according to clsi c24, a run is “an interval (i.e., a period of time or series of measur...
analytical sensitivity
    The ability of an analytical method to detect small quantities of the measured component. numerically characterized by determination of detection limit.
analytical specificity
    The ability of an analytical method to measure only the sought-for analyte or measurand. numerically characterized by determination of interferences and non-specific responses to other analytes or...
application characteristics
    Refer to those properties of a method which determine whether the method can be implemented in the particular laboratory of interest, assuming the method will perform acceptably. characteristics s...
assayed control material
    A control solution or control material for
    Used here to represent the bias of a measurement procedure relative to a comparative method or a comparative group in proficiency testing.
bland-altman plot
    The display of paired-data from a comparison of methods experiment by plotting the differences between the test and comparative results on the y-axis versus the average of the test and comparative...
calibration verification
    “the assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument, kit, or test system has remained stable throughout the laboratory’s ...
centers for disease control
    cdc; centros de control y prevención de;
      clinical laboratory improvement amendments of 1988;
      clinical laboratory improvement amendments of 1988
        clinical quality requirement
          Used here for a quality requirement that states the medically important change in a test result or describes the gray zone or decision interval for interpreting a test result.
          clinical laboratory and standards institute, formerly national committee for clinical laboratory standards (nccls);
          centers for medicare and medicaid services
            Центры служб "medicare" и "medicaid"
          cms; центры служб "medicare" и "medicaid"; центры служб;
          combined standard uncertainty
            Standard uncertainty of the result of a measurement when that result is obtained from the values of a number of other quantities, equal to the positive square root of a sum of terms, the terms bei...
          comparison of methods experiment
            A method validation experiment in which a series of patient samples are analyzed both by the test method (the one under study) and a comparison method (an established method). the purpose is to as...
          control chart
          1. "a graphical method for evaluating whether a process is or is not in a `state of statistical control.` the determinations are made through comparison of the values of some statistical measure(...
          control rule
            A decision criterion for interpreting control data and making a judgement on the control status of an analytical run. symbolized here by al, where a is the abbreviation for a particular statistic ...
          criteria for acceptability
            Clia`s term for the decision criteria applied to assess the validity of an analytical run. another name for qc procedure, with emphasis on definition of the decision criteria or control rules for ...