Immunochromatography devices, methods, and kits
View Patent ↗A membrane-based assay device, methods and kits for determining the presence or quantity of an analyte in a test sample are provided. The immunochromatographic device comprises a membrane having a capture antibody bound thereto at a test zone, wherein the capture antibody is capable of binding with an analyte, in particular a Z-AAT protein present in a sample from a PiZ gene carrier.
1. An immunoassay device comprising: a membrane having an alpha-1 antitrypsin protein comprising the Z-mutation (Z-AAT proteins) capture area defined by a capture antibody immobilized thereto, wherein the capture antibody is LG96, MG97, or comprises an antigen-binding fragment of either LG96 or MG97.
2. The device of claim 1 , further comprising a sample application area and a flow path from the sample application area to the Z-AAT protein capture area, wherein the presence or amount of a Z-AAT protein in a fluid sample can be determined by formation of a complex between the capture antibody and the Z-AAT protein that may be present in the fluid sample.
3. The device of claim 2 , further comprising a conjugate structure located in the flow path, wherein the conjugate structure comprises a detection reagent specific for the Z-AAT protein, the detection reagent being mobile or mobilizable.
4. The device of claim 3 , wherein the detection reagent comprises a detector antibody.
5. The device of claim 4 , wherein the detector antibody is LG96 or an antigen-binding fragment thereof.
6. The device of claim 4 , wherein the detector antibody is MG97 or an antigen-binding fragment thereof.
7. The device of claim 4 , wherein the detector antibody is labeled with a reporter moiety.
8. The device of claim 4 , wherein the detector antibody is a gold-conjugated detector antibody.
9. The device of claim 2 , wherein a source of the fluid sample is capillary blood, serum, or plasma.
10. An immunoassay device for determining the presence or amount of an alpha-1 antitrypsin protein comprising the Z-mutation (Z-AAT protein) in a fluid sample, the device comprising:
a sample application area;
a microporous membrane having a Z-AAT protein capture area defined by a capture antibody immobilized thereto, wherein the capture antibody is LG96 or antigen-binding fragment thereof;
a flow path from the sample application area to the Z-AAT protein capture area, wherein the presence or amount of a Z-AAT protein in a fluid sample can be determined by formation of a complex between the capture antibody and the Z-AAT protein that may be present in the fluid sample; and
a conjugate structure located in the flow path, wherein the conjugate structure comprises a detection reagent specific for the Z-AAT protein, the detection reagent being mobile or mobilizable, wherein the detection reagent is gold-conjugated LG96 or a gold-conjugated antigen-binding fragment thereof.
11. A method for detecting a Z-AAT protein in a subject, the method comprising:
applying a biological sample from the subject to the immunoassay device of claim 10 ; and
detecting a complex that is formed between the capture antibody and the Z-AAT protein that may be present in the fluid sample, wherein detection of the complex indicates the presence of the Z-AAT protein in the sample.
12. The device of claim 1 , further comprising:
a sample application area;
a flow path from the sample application area to the Z-AAT protein capture area, wherein the presence or amount of a Z-AAT protein in a fluid sample can be determined by formation of a complex between the capture antibody and the Z-AAT protein that may be present in the fluid sample; and
a conjugate structure located in the flow path, wherein the conjugate structure comprises a detection reagent specific for the Z-AAT protein, the detection reagent being mobile or mobilizable, wherein the detection reagent is gold-conjugated LG96 or a gold-conjugated antigen-binding fragment of LG96.
13. The device of claim 12 , wherein the capture antibody is LG96 or an antigen-binding fragment of LG96.