2: Method Validation, QA/QC, Measurement Uncertainty Flashcards
Non-targeted analytes which may impact the ability to detect, identify, or quantitate a targeted analyte:
Interferences
The lowest concentration of an analyte in a sample that can be reliably measured with acceptable bias and precision:
Limit of Quantitation
Day 1 mean: 23 ng/mL
Day 2 mean: 17 ng/mL
Day 3 mean: 21 ng/mL
Day 4 mean: 22 ng/mL
Day 5 mean: 19 ng/mL
Nominal Concentration: 15 ng/mL
What is the Bias(%)?
36%
(mean of results – expected result) / (expected result)
Precision is expressed as the coefficient of variation (%CV).
True False
True
How is CV% (precision) calculated?
(Standard deviation)/(mean) *100
The precision and accuracy in measurement of an analyte under a variety of analytical conditions:
Robustness
The lowest concentration for a specific analyte able to be detected by a defined method of analysis:
Limit of Detection
The ability to detect an analyte among a similar class of related compounds or their metabolites:
Method Specificity
This standard and its progeny rely on a “scientific knowledge” approach to determining whether expert testimony is not only relevant, but also reliable, and, therefore, admissible as evidence:
Daubert Standard
Random error plus systematic error equals:
Total Error
Systematic error affects:
Precision
Accuracy
Accuracy
Random error affects:
Precision
Accuracy
Precision
The acronym ISO stands for:
International Organization for Standardization
These studies are conducted to ensure that results reflect the true analyte concentration in a sample:
Recovery
Accuracy
Imprecision
Interference
Quality Control Selection
Accuracy
These studies are conducted to determine the reproducibility of measurements:
Recovery
Interference
Quality Control Selection
Imprecision
Accuracy
Imprecision
Accuracy of a result is based upon these two variables:
Bias and precision
LLOQ and LOD
Recovery and precision
Precision and Accuracy
Matric Effects and Bias
Bias and precision
Defined as the absolute recovery of analyte without use of an internal standard:
Analytical Recovery
This is an indicator of the linearity of a calibration line:
Correlation Coefficient
