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
