Quality/process control of a lateral flow assay device based on flow monitoring

摘要

A method for providing quality control on a lateral flow assay device or for triggering a process-related step, the device including a substrate having at least one sample receiving area, at least one reagent zone downstream and in fluid communication with the at least one sample receiving area, at least one detection zone downstream and in fluid communication with the at least one reagent zone and at least one wicking zone downstream of the at least one detection zone, each fluidly interconnected therewith along at least one fluid flow path. The detection material provided in the at least one reagent zone produces a detectable signal that can be tracked and monitored prior to the completion of at least one test being performed on the lateral flow assay device.

主权项

1. A method for providing quality control upon a lateral flow assay device, said assay device comprising a substrate having a plurality of discrete zones including at least one sample addition zone, at least one detection zone downstream of said at least one sample addition zone and at least one wicking zone downstream of said at least one detection zone, each of said zones being fluidly interconnected along a folded fluid flow path through which sample flows under capillary action from said sample addition zone to said wicking zone, said method comprising the steps of:
adding sample to the sample addition zone; combining sample and a reagent, wherein the sample and reagent may be combined prior to the adding of sample to the sample addition zone or on the assay device, said reagent including at least one detection material that produces a detectable signal; initiating a timer from the time that sample is added or the device is loaded within a testing apparatus that causes sample to be added to the sample addition zone of the assay device; using a reader apparatus, conducting periodic readings of said at least one detection zone of the assay device following the timer initiating step until the presence of the detectable signal caused by the dissolution of the detection material by the flowing sample is detected by the reader apparatus; and comparing the elapsed time to a predetermined standard time interval to determine whether the assay device is operating properly.