Multianalyte assay
View Patent ↗The invention provides compositions, systems and methods for detecting multiple analytes from a sample.
1. A kit comprising:
a) a sample collection device having an open end, and comprising;
i) a sample tube;
ii) a sample collection implement;
iii) a dropper cap;
iv) a compartment comprising an extraction reagent;
wherein lyophilized immunoreagents are provided in a chamber proximal to the open end or in the dropper cap; and
b) a test device comprising one or more addressable regions configured for detection of one or more analytes, wherein the kit is for detection of the one or more analytes by immunoassay.
2. The kit of claim 1 , wherein said extraction reagent comprises a salt at about 0.75 to about 1.125M in a buffered solution.
3. The kit of claim 1 , wherein said extraction reagent comprises saponin at about 1.0% to about 1.5% in a buffered solution.
4. The kit of claim 1 , wherein said extraction reagent comprises a zwitterionic agent at about 0.25% to about 0.5% in a buffered solution.
5. The kit of claim 1 , wherein said one or more analytes comprises one or more virus or virus components.
6. The kit of claim 5 , wherein said virus is influenza A and/or influenza B.
7. The kit of claim 6 , wherein said influenza A includes subtypes of a formula HxNy, where x is 1 through 16, and y is 1 through 9, or any combination of xy thereof.
8. The kit of claim 6 , wherein said influenza A is H5N1.
9. The kit of claim 5 , wherein said dropper cap comprises a plurality of pairs of detection and capture probes.
10. The kit of claim 5 , configured to provide a limit of sensitivity for detection of said one or more different analytes of at least about 10 TCID 50 per mL as measured by tissue culture infectious dose 50 (TCID 50 ).
11. The kit of claim 1 , wherein said one or more analytes comprises one or more analytes associated with heart damage, heart disease or heart condition.
12. The kit of claim 1 , wherein said one or more analytes comprises one or more analytes associated with brain damage, brain disease or brain condition.
13. The kit of claim 1 , configured to provide a limit of sensitivity and specificity for detection of said one or more different analytes of at least about 97%.
14. The kit of claim 1 , configured to provide a limit of sensitivity for detection of said one or more different analytes of at least about 0.030 pg/ml.
15. The kit of claim 1 , configured to provide a limit of sensitivity for detection of said one or more different analytes of at least about 1.5 attomoles.
16. The kit of claim 1 , wherein the lyophilized immunoreagents are provided in the chamber proximal to the open end.
17. The kit of claim 16 , wherein the immunoreagents comprise one or more pairs of detection and capture probes, and wherein the kit is configured to provide a limit of sensitivity for detection of said one or more different analytes of at least about 0.030 pg/ml.
18. The kit of claim 16 , wherein the immunoreagents comprise one or more pairs of probes comprising a detection probe and a capture probe, wherein said one or more pairs of probes is configured to detect one or more different analyte.
19. The kit of claim 1 , wherein the lyophilized immunoreagents are provided in the dropper cap.
20. The kit of claim 19 , wherein the immunoreagents comprise one or more pairs of detection and capture probes, and wherein the kit is configured to provide a limit of sensitivity for detection of said one or more different analytes of at least about 0.030 pg/ml.
21. The kit of claim 19 , wherein the immunoreagents comprise one or more pairs of probes comprising a detection probe and a capture probe, wherein said one or more pairs of probes is configured to detect one or more different analyte.
22. The kit of claim 1 , wherein the one or more analyte is a peptide or a protein.