Terminology It is important to understand the difference between reportable range, analytical measurement range (AMR
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What is the reportable range of an analytical method?
Manufacturers make claims for the reportable range of their methods by the stating the upper and lower limits of the range. 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.
What is the difference between reference range and reportable range?
Reportable range should not be confused with reference range. Reportable range includes analytical measurement range (AMR) and clinically reportable range (CRR). AMR is defined as the range of values an instrument can report directly without dilution or concentration.
How do you determine the reportable range of data?
The measured results are plotted on the y-axis vs the expected or known values on the x-axis. The reportable range is then assessed by drawing the best straight line through the linear portion of the data.
What is the reportable range of an assay?
Reportable range is the functional range of an assay over which the concentrations of an analyte can be measured with acceptable accuracy and precision. Reportable range should not be confused with reference range. Reportable range includes analytical measurement range (AMR) and clinically reportable range (CRR).
What is the difference between reportable range and reference range?
Reportable range is the functional range of an assay over which the concentrations of an analyte can be measured with acceptable accuracy and precision. Reportable range should not be confused with reference range. Reportable range includes analytical measurement range (AMR) and clinically reportable range (CRR).
What is reportable range for a test?
Reportable range means the span of test result values p g p over which the laboratory can establish or verify the accuracy of the instrument or test system measurement response.
What is the difference between linearity and AMR?
AMR is the same as 'reportable range' in CLIA terminology. Reportable range is defined as the span of test result values over which the accuracy can be verified or test system response can be established. Linearity is the method employed to determine the AMR.
What is linear reportable range?
The reportable range is that range within which a specified method produces results within defined allowable error without resorting to dilution of the specimen. The reportable range assumes a linear relationship between true analyte concentration and analytical results.
What is analytical range?
Analytic Measurement Range (AMR)4 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.” This concept derives from the CLIA description of reportable range, but is limited to measurements ...
What is analytical working range?
Each instrument used in analytical chemistry has a useful working range. This is the range of concentration (or mass) that can be adequately determined by the instrument, where the instrument provides a useful signal that can be related to the concentration of the analyte.
What is the difference between calibration and verification?
A calibration indicates the error of the instrument and compensates for any lack of trueness by applying a correction. A verification indicates that the measurement error is smaller than a so called maximum permissible error.
What is linearity in analytical method validation?
ROLE OF LINEARITY IN ANALYTICAL METHOD VALIDATION The linearity of an analytical method is it's ability to elicit test results that are directly proportional to the concentration of the analyte in samples within a given range.
What is AMR value?
The "amr" value is an array of case sensitive strings. The "amr" values defined by this specification is not intended to be an exhaustive set covering all use cases. Additional values can and will be added to the registry by other specifications.
What is linearity in analytical chemistry?
Linearity refers to the relationship between the final analytical result for a measurement and the concentration of the analyte being measured. This distinction is relevant because a plot of analyte concentration versus measurement signal from the instrument may not be linear.
What is a linearity range?
Linearity (analytical range) is assessment of the range over which results can be obtained without the need for dilution, reflecting the range over which there is a proportional relationship between analyte concentration and signal [23].
Is calibration verification the same as linearity?
The user manual may also refer to calibration verification in lieu of linearity, or it may refer to both terms. And in many instances, but not all, the manufacturer may include a calibration verification/linearity kit with the initial shipment of the test system to be used upon initial set-up.
Laboratory Technology
At the outset, validating a new instrument may seem like a daunting task. Lab accrediting agencies describe how these tasks should be accomplished, but their use of varying terminology adds confusion to the process.
Guidelines, Clarification
Prior to implementing an FDA-cleared or approved test system and reporting patient results, U.S. laboratories subject to CLIA ’88 must demonstrate that [their instrument] can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:
Linearity
Linearity is achieved when measured results are directly proportional to the concentration of the analyte in the test sample, within a given range.
Calibration Verification
Calibration verification is the assaying materials of known concentration in the same manner as patient samples to substantiate the instrument’s calibration throughout the reportable range for patient test results.
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What type of experiment is used to check the reportable range for a test?
Factors to consider. CLIA does not strictly require that a method provide a linear response, but laboratories commonly use a "linearity" type of experiment to check the reportable range for a test. In this experiment, a laboratory will analyze a series of samples with known concentrations, or a series of diluted samples.
How to make claims for reportable range?
Manufacturers make claims for the reportable range of their methods by the stating the upper and lower limits of the range. 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.
Can standard solutions be used for proficiency testing?
Standard solutions may be easy to prepare for some tests. For others, manufacturers and proficiency testing agencies may supply linearity sets having known values or known relationships between materials. Dilutions of patient specimens, or pools of patient specmens, may also be used and are often convenient and economical when high values are available. In some cases, e.g., TDMs, it may be necessary to spike a pool with the analyte to be measured in order to get the desired high level.
