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 lateral flow assay device comprising:
a substrate; at least one sample addition zone; at least one detection zone downstream and fluidly connected with the at least one sample addition zone, the at least one detection zone being disposed along a linear detection path that enables a detection instrument to determine the presence of at least one analyte of interest in the at least one detection zone; a wicking zone downstream of the at least one detection zone, each of the zones being fluidly interconnected to form a flow path in which sample flows under capillary action from the at least one sample receiving zone to the wicking zone and in which sample is combined with a reagent, the reagent including at least one detection material that produces a detectable signal; and at least one capillary channel for diverting a portion of sample, the at least one capillary channel extending from a portion of the flow path and further extending through the linear detection path of the assay device to permit in situ detection thereof.