Analytical Method Validation

After choosing the best analytical method to be used, which includes the type of analytical principle (e.g., HPLC), hardware, extraction, and reconstitution procedures (isolation of the analyte from the sample matrix), the limitations of the complete assay need to be determined. Analytical method validation essentially consists of three discrete steps: (1) assessing

FIGURE 3 RIA Standard Curve. The X-axis is the log of the concentration range (1 to 100 units), and the Y-axis reports the amount of radioactive tracer that is bound to the antibody. As increasing amounts of nonlabeled analyte from the sample are incubated, increasing fractions of the radioactive tracer are displaced. Therefore, the curve declines with increasing concentrations of unlabeled analyte.

FIGURE 3 RIA Standard Curve. The X-axis is the log of the concentration range (1 to 100 units), and the Y-axis reports the amount of radioactive tracer that is bound to the antibody. As increasing amounts of nonlabeled analyte from the sample are incubated, increasing fractions of the radioactive tracer are displaced. Therefore, the curve declines with increasing concentrations of unlabeled analyte.

the limits of the analytical assay, (2) determining the effect of sample handling, and (3) monitoring assay quality during practical use.

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