Method Validation Deck (Exam 1)

Question 1

This is the process of proving that an analytical method is acceptable.

Answer 1

What is method validation?

Question 2

Which of these options is a viable use for method validation? Developing new methods, revising or extending use of old methods, establishing methods used in other labs and by other analysts, or following a period of non-use.

Answer 2

Trick question. All of the above

Question 3

What is the general flowchart of method validation (HINT: sacked or SAC’D?

Answer 3

Sample prep > analysis > calibration > data evaluation

Question 4

This is a chemical compound that is being measured or analyzed?

Answer 4

What is an analyte?

Question 5

This is a specimen of fluid or tissue.

Answer 5

What is a biological matrix?

Question 6

This is the known purity and molecular composition.

Answer 6

What is reference standard?

Question 7

This is a structurally-related compound or deuterated analog of the target analyte being measured (HINT: CANNOT be target analyte).

Answer 7

What is an internal standard?

Question 8

This is an aliquot of the biological matrix match that contains no target analytes or internal standards.

Answer 8

What is a blank?

Question 9

This specimen contains analyte at a known concentration to verify calibration.

Answer 9

What is a positive control?

Question 10

This specimen contains no analyte to verify the absence of interferences.

Answer 10

What is a negative control?

Question 11

These are substances present in a specimen or during sample prep that cause chromatography or quantitation problems.

Answer 11

What are interferants?

Question 12

These are solutions of known concentration prepared in the biological matrices which are used to establish the relationship between what is measured, the “response,” and the analyte concentration i.e. these solutions establish/construct calibration.

Answer 12

What are calibrators?

Question 13

This is the smallest amount of analyte measured in relative concentration that can be detected with reasonable certainty (HINT: the answer is literally in the definition).

Answer 13

What is limit of detection (LOD)?

Question 14

This is the lowest concentration of analyte that can be measured with a defined precision and accuracy for a particular method.

Answer 14

What is limit of quantification (LOQ)?

Question 15

This is the closeness of the measured quantitative response to the actual value.

Answer 15

What is accuracy?

Question 16

This is the measurement of agreement among test results.

Answer 16

What is precision?

Question 17

This is the ratio of a drug’s peak area to the peak area of the internal standard used to measure instrument response.

Answer 17

What is peak area ratio?

Question 18

What is the ideal LOD signal to noise ratio?

Answer 18

3 to 1

Question 19

What is the ideal LOQ signal to noise ratio?

Answer 19

10 to 1

Question 20

This is the measure of percent calculating by dividing the standard deviation by the mean.

Answer 20

What is coefficient of variance?

Question 21

This is the ability to identify an analyte from those compounds that are structurally related.

Answer 21

What is specificity?

Question 22

This is the measurement of contamination from a previous specimen analysis to the following analysis.

Answer 22

What is carryover?