PRELIM LEC: Quality Assurance (BISHOP)

The foundation for monitoring performance (known as QC) is

This symmetrical shape is often called a

describes many continuous laboratory variables and shares several unique characteristics

summarizes the above relationships between the area under a Gaussian distribution and the SD

provides objective an objective measure of the line of best fit for the data

Three factors are generated in a linear regression

An alternate approach to visualizing paired data is the difference plot, which is also known as the

The difference between test and reference method results is called

is a measure of the strength of the relationship between the two methods

There are two kinds of error measured in COM experiments:

is present in all measurements and can be either positive or negative, typically a combination of both positive and negative errors on both sides of the assigned target value

influences observations consistently in one direction (higher or lower).

Systematic error can be further broken down into

exists when there is a continual difference between the test method and the comparative method values, regardless of the concentration

exists when the differences between the test method and the comparative method values are proportional to the analyte concentration

are used to draw conclusions (inferences) regarding the means or SDs of two sets of data

is the cause of lack of precision or the imprecision in a test

Ability of a method to detect small quantities or small changes in concentration of an analyte

Ability of a method to detect only the analyte it is designed to determine, also known as cross-reactivity

Range of analyte that a method can quantitatively report, allowing for dilution, concentration, or other pretreatment used to extend AMR

Also known as linear or dynamic range. Range of analyte concentrations that can be directly measured without dilution, concentration, or other pretreatment

Lowest amount of analyte accurately detected by a method

Lowest amount of analyte that can be reported while achieving a precision target (e.g., lowest concentration at which a CV of 10% may be achieved)

Refers to the difference between the measured value and the mean expressed as a number of SDs. An SDI = 0 indicates the value is accurate or in 100% agreement; an SDI = 3 is 3 SDs away from the target (mean) and indicates inaccuracy. SDI may be positive or negative