Interference Control Panel for Evaluation of Analytical Assays For Samples Derived from Blood
AssigneeLife Technologies Corporation
InventorMichael J. ECK
Life of this patent
Estimating the term…
Abstract
The invention relates to quality control of analytical assays, particularly NAT assays of blood samples containing nucleic acids. A control panel containing quantified amounts of substances known to interfere with an analytical assay is used and compared with a reference sample in the analytical assay. A comparison of the assay results interference panel validates the assay and can serve as a periodic quality control check for the analytical assay as well as related methods and protocols. The use of the control panel of the invention can also determine whether interfering substances are present and establish under what conditions the analytical assay reliable.
Claims20
A method for determining the presence of substances in an analytical assay comprising:
- adding a known amount of an analyte to two or more members of an inhibition panel, wherein each member of the inhibition panel contains a potentially inhibition of the analytical assay,
- performing the assay to measure the analyte,
- comparing a measurement of reference plasma sample with the measurement of at least one member of an inhibition panel, wherein the comparison indicates the presence an actual inhibition of the analytical assay.
A kit for evaluating the performance of an analytical assay comprising:
- a panel comparing vials of a plurality of inhibitory substances wherein each substance is quantified to a known concentration and volume, and
- analyte at a known concentration to be added to each panel member.
Dependencies are inferred from the claim text.