Calibration of fluidic devices

摘要

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

主权项

1. A method for use with a bodily sample, comprising:
providing a system, said system comprising a fluidic device, said fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the bodily sample to react with reactants contained within said assay assembly, and a reader assembly for detecting the presence of said analyte; using at least one reader assembly shipping condition sensor and at least one assay assembly shipping condition sensor to determine a change during shipping of the reader assembly or the assay assembly that impact operation parameters under which the system normally operates, wherein the assay assembly shipping condition sensor is operable to detect change even when not operably coupled to the reader assembly; coupling said fluidic device with the reader assembly to perform the assay; using a detector on the reader assembly to obtain shipping condition data from said shipping condition sensor located on the fluidic device when the fluidic device is coupled to the reader assembly; using a communication assembly on the reader assembly to send said shipping condition data and raw assay data to a computer server external to the reader assembly; evaluating both the reader assembly and the assay assembly to provide an analyte measurement based on shipping condition data and raw assay data sent to the server.