Method Validation

Question 1

Reference Material

Answer 1

Authentic analyte of known purity

Question 2

Standard

Answer 2

A concentration solution of reference material used to prepare calibrators and controls

Question 3

Calibrator

Answer 3

A blank matrix fortified with target analyte used to establish the relationship between the measured response and the analyte concentration

Question 4

Control

Answer 4

A blank matrix fortified with target analyte or a pool of actual specimens containing the analyte used to check the calibration

Question 5

Bias

Answer 5

Closeness of a measured result to the actual result

Question 6

Precision

Answer 6

Consistency of replicate measurements of the same homogeneous sample

Question 7

Limit of Detection

Answer 7

An estimate of the lowest concentration of an analyte in a sample the can be reliably differentiated from blank matrix

Question 8

Limit of Quantitation

Answer 8

An estimate of the lowest concentration of an analyte in a sample that can be measured with acceptable bias and precision

Question 9

Carryover

Answer 9

The appearance of unintended analyte signal in samples after the analysis of a positive sample

Question 10

Dilution Integrity

Answer 10

Assures that the bias and precision are not significantly impacted when a sample is diluted

Question 11

Stability

Answer 11

An analyte’s resistance to chemical change in a matrix under specific conditions for given time intervals

Question 12

Interferences

Answer 12

Non-targeted analytes or endogenous substances that may impact the ability to detect, identify or quantitate a targeted analyte