Methods for threshold determination in multiplexed assays

摘要

Methods for determination of threshold values of signatures comprised in an assay are described. Each signature enables detection of a target. The methods determine a probability density function of negative samples and a corresponding false positive rate curve. A false positive criterion is established and a threshold for that signature is determined as a point at which the false positive rate curve intersects the false positive criterion. A method for quantitative analysis and interpretation of assay results together with a method for determination of a desired limit of detection of a signature in an assay are also described.

主权项

1. A method for determination of threshold values of signatures composing an assay, each signature enabling detection of a target, the method comprising:
providing an assay, said assay comprising signatures, said signatures enabling detection of a target, and for each signature:
determining a probability density function (PDF) of negative samples in the assay;based on the determined PDF of negative samples, determining a false positive rate curve;generating a calibration curve of assay response parameter values versus concentration;generating a plot of false positive rate versus the limit of detection (LOD);selecting a LOD such that a desired false positive rate is obtained; anddetermining the threshold corresponding to the selected LOD.