Description
Assay Performance Data
Accuracy and Precision are critical to bioassays and the development of biologics. The IL-2 Bioassay is both accurate and precise. Accuracy is a measure of how close results are to a target or reference value. Precision is a measure of repeatability. This assay was developed and prequalified according to ICH guidelines for accuracy and precision, giving it the performance characteristics required for many applications of a bioassay used for antibody drug discovery research and development.
Accuracy: Measure of ability to replicate a reference or "target" value.
IntraLab Precision: Measure of repeatability from multiple assays of the same homogeneous sample under the same operating conditions over a short time (same analyst; same lab; same day).
Intermediate Precision: Measure of repeatability of multiple assays of the same homogeneous sample with different analysts or equipment or on different days.
Linearity: Ability of your assay to provide measured values that are proportional to the concentration of the sample.
The IL-2 Bioassay Shows Precision, Accuracy and Linearity.
IL-2 Bioassay is responsive to recombinant IL-2.
The IL-2 Bioassay indicates stability.
IL-2 Bioassay Cells were incubated with serial dilutions of recombinant IL-2. After a 6-hour incubation, Bio-Glo™ Reagent was added, and luminescence was quantified using the GloMax® Discover System.
Proleukin® (aldesleukin; Clinigen, 1.1mg/ml undiluted) was heat stressed at 53°C prior to being tested in the IL-2 Bioassay. Bio-Glo™ Reagent was added, and luminescence was quantified using the GloMax® Discover System.