What is clinical reportable range?

The clinically reportable range is the range of analyte values that a method can measure, allowing for specimen dilution, concentration, or other pretreatment used to extend the direct analytical measurement range. The AMR cannot exceed the manufacturer’s limits.

What is difference between AMR analytical measurement range and clinically reportable range?

Analytical measurement range: range of analyte values that a method can directly measure on the specimen without any dilution, or other pretreatment not part of the usual assay process. Reportable range: span of test result values over which the lab can establish or verify the accuracy of the measurement response.

How do you establish a reportable range?

Establishing the reportable range is a one-time activity for each method (not each instrument), and is accomplished by analyzing at least three levels of materials; low, midpoint, and high, with known values. The CAP has very specific requirements for establishing each method or instrument’s reportable range.

What is linear reportable range?

Linearity studies are performed to determine the linear reportable range for an analyte. This is done using a set of standards containing varying levels of an analyte in high enough and low enough concentrations so as to span the entire range of the test system.

How do you validate reportable range?

Validation can be accomplished using at least three levels of commercial linearity materials, standards or calibrators that span the lower limit, mid-point and upper limit of AMR. AMR validation can also be done by calibration verification (see below).

What is a validation method?

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.

What is AMR in lab?

The ANALYTICAL MEASUREMENT RANGE (AMR) 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.

What is linearity in lab?

Linearity is an objective description of the relationship between a quantitative method’s final answer and true analyte concentration. The reportable range assumes a linear relationship between true analyte concentration and analytical results.

What is calibration verification?

Calibration verification means the assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results.

Why linearity is required?

Linearity studies are important because they define the range of the method within which the results are obtained accurately and precisely. In case of impurities with very small amounts to be quantified, the limit of quantification (LOQ) needs to evaluated. For the LOQ, trueness is also mandatory.

Is AMR the same as linearity?

Linearity refers to the relationship between the final analytical result for a measurement and the concentration of the analyte being measured. Related to linearity is the concept of the analytical measurement range (AMR).