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:
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 Lot 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%.
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%.
Overall Stability: The standard curve and a high-level, mid-level, and low-level positive control must perform to within 2 standard deviations of Day 0 data for at least 1 year when stored at 4oC.
Shipping Stability: The standard curve and a high-level, mid-level, and low-level positive control must perform to within 2 standard deviations of Day 0 data after kits are exposed to either 4 hours of either -20oC or 45oC followed by 16 hours at 25oC, then stored at 4oC for 9 weeks.
Opened Kit Stability: The standard curve and a high-level, mid-level, and low-level positive control must perform to within 2 standard deviations of Day 0 data after kits are opened, all regents reconstituted, and kits stored at 4oC, -20oC, or -80oC for 4 weeks.
An example of a validation report that includes real data for each of the tests specified above is available upon request. Once a product is validated in the Quansys R&D department, each future Lot of reagent and plates is tested using similar criteria by our Quality Control department before being released for sale.
As researchers and problem solvers ourselves, we understand the value of sound data. We are proud to be a part of research that can better the world. We value the relationships, partnerships, and friendships that we have built with the people who trust and use our technology. We are committed to building these relationships. You can count on us to answer the phone and take time to thoroughly address questions or concerns about any of our products. In an industry that is reputed for grandiose claims, we trust that our quality standards and our customer service set us apart from the competition. If you’re happy with our products or if you think we can do something better, we hope you will let us know.