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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:

Precision

Edge Effects

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%.

Intra-Assay

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%.

Inter-Assay

The %CV for 4 replicates on 20 plates from 3 different lots run by 3 users must also be below 15%.

Specificity

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.

Recovery

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.

Linearity

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.

Drift

The % difference between samples added to the plate at 0 minutes and 10 minutes must not exceed 15%.

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