Multianalyte assay
The invention provides compositions, systems and methods for detecting multiple analytes from a sample.
1. A method of assaying a sample to detect one or more analytes comprising:
a) providing a sample to a sample collection device (SCD), the SCD comprising:
i) a dropper cap, wherein the dropper cap comprises at least a pair of probes comprising a detection probe and a capture probe, each of which is capable of specifically binding an analyte, and wherein the dropper cap is configured with an outlet; and
ii) an extraction reagent;
b) administering the sample from said SCD through the outlet to a test device (TD) configured to detect said one or more analytes, wherein said TD comprises;
i) an aperture for receiving said SCD and where said TD does not comprise a mobilizable entity capable of specifically binding said one or more analytes; and
ii) at least one immobilized capture moiety which is capable of specifically binding a component of said capture probe; and thereby assaying said sample to detect said one or more analytes.
2. The method of claim 1 , wherein said extraction reagent comprises a salt at about 0.75M to about 1.125M in a buffered solution.
3. The method of claim 1 , wherein said extraction reagent comprises saponin at about 1.0% to about 1.5% in a buffered solution.
4. The method of claim 1 , wherein said extraction reagent contains a zwitterionic agent at about 0.25% to about 0.5% in a buffered solution.
5. The method of claim 1 , wherein said zwitterionic agent is zwittergen 3/17.
6. The method of claim 1 , wherein said one or more analytes comprises one or more virus or virus components.
7. The method of claim 6 , wherein said virus is influenza A and/or influenza B.
8. The method of claim 7 , 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.
9. The method of claim 7 , wherein said influenza A is H5N1.
10. The method of claim 6 , 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 method of claim 1 , wherein said one or more analytes comprises one or more bacteria or bacterial components.
12. The method of claim 1 , wherein said one or more analytes comprises one or more cancer cell or cancer cell component.
13. The method of claim 1 , wherein said one or more analytes comprise one or more analytes associated with heart damage, heart disease or heart condition.
14. The method of claim 1 , wherein said one or more analytes comprises one or more analytes associated with brain damage, brain disease or brain condition.
15. The method of claim 1 , wherein the at least a pair of probes in said dropper cap comprises a plurality of pairs of detection and capture probes.
16. The method of claim 1 , configured to provide a limit of sensitivity and specificity for detection of said one or more analytes of at least about 97%.
17. The method of claim 1 , configured to provide a limit of sensitivity for detection of said one or more analytes of at least about 0.030 pg/ml.
18. The method of claim 1 , configured to provide a limit of sensitivity for detection of said one or more analytes of at least about 1.5 attomoles.
19. The method of claim 1 , wherein the dropper cap further comprises a screen, wherein the at least a pair of probes comprising a detection probe and a capture probe are held inside the dropper cap by the screen, wherein the screen functions as a size-based or affinity based filter.
20. The method of claim 19 , wherein the screen is mesh or filter paper.