Molecular Diagnostic Assay Device And Method Of Use

摘要

Lateral flow devices and methods of use for a molecular diagnostic assay are provided. The method is suitable for detection or monitoring of targets, including biological, chemical, and material targets that exist in very low concentrations in biological samples. The methods and devices of the present application are amenable to power source-free point of care testing.

主权项

1. A method of detecting an analyte in a test sample, the method comprising;
i) providing a lateral flow assay device that comprises a chromatographic medium that includes:
(a) a sample loading zone located upstream of a detection zone;(b) a reporting carrier zone located between the sample loading zone and a detection zone, wherein said reporting carrier zone comprises a reporting carrier capable of forming a complex with the analyte said reporting carrier comprising a carrier and one or more proficient enzyme cassettes; and(c) a detection zone, wherein the detection zone comprises a capture component for the analyte and an indicator; ii) Contacting the sample application zone with the test sample, wherein the test sample travels through the reporting carrier zone along the chromatographic medium from the sample loading zone to the detection zone and beyond the detection zone; iii) adding a substrate to the detection zone wherein the substrate undergoes a reaction in the presence of proficient enzyme analyte containing reporting carrier; and iv) generating a response of the indicator within the detection zone that corresponds to the presence or absence of the analyte in the test sample.