Category 1
Closeness of agreement between the result of a measurement and a true concentration of the analyte
Accuracy
What procedure should I perform when I install a new analyser instead of an old one
Verification
Closeness of agreement between independent results of measurements
Precision
What procedure should I perform when I have developed a new ELISA method inhouse
Validation
Closeness of agreement between results of successive measurements carried out under the same conditions
Repeatability
What is the analyte concentration range over which measurements are within the declared tolerances for imprecision and bias of the method
Analytical Measurement range
The range of analyte values a method can measure and report, including potential dilutions or other pretreatment used to extend the direct measurement range
Clinical Reportable range
Closeness of agreement between results of measurements performed under changed conditions
Reproducibility
lowest value that significantly exceeds the measurements of a blank sample
Limit of Detection
The probability of classifying a result as negative when the true value indeed is below the cutoff
Specificity
The probability of classifying a result as positive when the true value indeed exceeds the cutoff
Sensitivity
Lowest concentration of an analyte in a sample that can be measured with acceptable accuracy and precision
Limit of Quantification
Minimum number of samples required to perform method verification
20
Ability of an assay procedure to determine the concentration of the target analyte without influence from potentially interfering substances or factors in the sample matrix
Analytical Specificity
How is error limit calculated during carryover analysis
SD x 3
What is acceptable correlation coefficient during method comparison
0.95 -1.05