Dry reagent strip configuration, composition and method for multiple analyte determination
View Patent ↗An assay device, analytical instrument and assay method for determining the presence or amount of an analyte in a fluid is disclosed. The device is a one-step lateral flow dry reagent immunoassay with one, two or more zones along a transverse axis of the device, each zone can contain or be preceded by diffusively or non-diffusively bound reagents. The invention measures an indicator in one or two test zones for each analyte to determine its presence or concentration. The signal reagent (indicator) may be a particle such as a colored latex or colloidal gold. The assay quantitation may be read by an instrument.
1. A dry reagent lateral flow strip assay device for detecting two or more analytes in a test sample comprising:
a) a sample application zone; and
b) two or more test zones;
wherein the sample application zone and the two or more test zones are in fluid communication with one another through a transport matrix; and wherein the transport matrix further comprises a lateral path along which the sample travels in a lateral direction, and a transverse path along which the sample travels in a direction transverse to said lateral path, said lateral path being in a two-dimensional plane and said transverse path being in a third dimensional plane so as to direct said test sample to said two or more test zones.
2. The assay device of claim 1 for performing general chemistry assays, wherein the two or more test zones are general chemistry reagent zones comprising at least one enzyme.
3. The assay device of claim 2 , wherein the enzyme produces a reaction product when at least one of the analytes is present in the sample.
4. The assay device of claim 1 , wherein the two or more analytes are general chemistry analytes selected from the group consisting of: creatine, creatinine, glucose, cholesterol, high density lipoprotein (HDL) cholesterol, N-telopeptide, low density lipoprotein (LDL) cholesterol, triglycerides and blood urea nitrogen (BUN).
5. The assay device of claim 1 , wherein one of the at least two or more test zones is a general chemistry reagent zone, said general chemistry reagent zone further comprising an indicator.
6. The assay device of claim 5 , wherein the indicator forms a detectable signal when at least one of the analytes is present in the sample.
7. The assay device of claim 1 for performing a binding assay, wherein the two or more test zones are binding member zones comprising at least one binding member.
8. The assay device of claim 7 , wherein the binding member is an antibody.
9. The assay device of claim 8 , wherein the antibody is immobilized in the binding member zone.
10. The assay device of claim 9 , wherein the antibody is diffusively immobilized in the binding member zone.
11. The assay device of claim 9 , wherein the antibody is non-diffusively immobilized in the binding member zone.
12. The assay device of claim 7 , wherein at least one of the binding members forms a complex with at least one analyte.
13. The assay device of claim 7 , wherein at least one of the binding member zones further comprises an indicator that forms a detectable signal when at least one of the analytes is present in the sample.
14. The assay device of claim 1 , wherein the two or more analytes are selected from the group consisting of: antigens, antibodies, macromolecules, vitamins, lectins, carbohydrates, proteins, peptides, amino acids, hormones, steroids, therapeutic drugs, drugs of abuse, bacterium and viruses.
15. The assay device of claim 1 , wherein the two or more analytes are haptens that form binding pairs with antibodies.
16. The assay device of claim 1 , wherein the sample application zone further comprises a sample pad in fluid communication with the transport matrix.
17. The assay device of claim 16 , further comprising a sample treatment pad in fluid communication with the transport matrix.
18. The assay device of claim 17 , wherein the sample treatment pad comprises a quarternary ammonium derived membrane for trapping ascorbate and other anionic interferents.
19. The assay device of claim 16 , further comprising a sample filter pad in fluid communication with the transport matrix for removing undesired contaminants from the sample.
20. The assay device of claim 16 , wherein the sample pad removes large particulate debris from the sample.
21. The assay device of claim 16 , wherein the sample pad adjusts the pH and ionic composition of the sample.
22. The assay device of claim 1 , wherein the transport matrix is a porous material along which the sample travels laterally.
23. The assay device of claim 1 , further comprising a metering layer between the transport matrix and the two or more test zones through which the sample spreads uniformly across the transport matrix.
24. The assay device of claim 1 , further comprising a detection zone corresponding to each test zone.
25. The assay device of claim 1 , further comprising a sample treatment pad overlapping said transport matrix, a first layer also overlapping said transport matrix, and a second layer overlapping said first layer.
26. The assay device of claim 25 , wherein said two or more test zones are located in said second layer.
27. A dry reagent lateral flow strip assay device for detecting two or more analytes in a test sample comprising:
a) a sample application zone; and
b) two or more test zones;
wherein the sample application zone and the two or more test zones are in fluid communication with one another through a transport matrix;
wherein said sample application zone further includes a sample pad and a sample treatment pad in fluid communication with said transport matrix;
wherein said sample treatment pad comprises a quaternary ammonium derived membrane for trapping ascorbate and other anionic interferents; and
wherein the transport matrix further comprises a lateral path along which the sample travels laterally, and a transverse path along which the sample travels transversely.