How are Q-Plex Arrays validated?
Every Quansys product is built such that each assay in the array passes precision, specificity, recovery, linearity, drift, and stability criteria. Custom products may have specialized criteria depending on customer needs. General validation criteria for our non-custom quantitative products include the following:
The % difference between replicates of a mid-level positive control run in the outer wells and inner wells of a 96-well plate must be below 10%.
The %CV for 20 replicates of a high-level, mid-level, and low-level positive control over 4 plates from the same must be below 15%.
The %CV for 4 replicates on 10 plates from 3 different lots run by 3 users must also be below 15%.
The % cross reactivity must be below 1% between all assays in an array Standard Curve: %Backfit obtained using a 5PL regression model must be between 80%-120% for all points of the standard curve.
The % recovery of a high-level, mid-level, and low-level positive control should preferably be between 80%-120% in serum and plasma (or other sample types as arranged). If this is not feasible, then % recovery must replicate over multiple tests.
The % linearity must be between 80%-120% in serum and plasma (or other sample types as arranged) for at least 5 points of a 1:2 dilution series of a high-level positive control.
The % difference between samples added to the plate at 0 minutes and 10 minutes must not exceed 15%.