CORONAVIRUS ASSAY

1 . A method for detecting a coronavirus in a sample from a subject, the method comprising:

subjecting the sample to a double binding moiety sandwich assay comprising a first and a second binding moiety,

wherein the first binding moiety comprises a soluble ACE2 receptor, or a variant or fragment thereof, or an anti-coronavirus antibody,

wherein the first binding moiety is labeled with a detectable label or a capture agent, and

wherein the second binding moiety is attached to a detectable label or a capture agent, and

wherein the first binding moiety and the second binding moiety can bind the coronavirus to form a complex comprising the first binding moiety, the coronavirus, and the second binding moiety.

2 . The method of claim 1 , wherein at least one of the first and second binding moieties comprises a soluble ACE2 receptor, or a variant or fragment thereof.

3 . The method of claim 1 or claim 2 , wherein the soluble ACE2 receptor comprises an ACE2-Fc fusion protein.

4 . The method of claim 3 , wherein the first binding moiety comprises an anti-coronavirus antibody or fragment thereof, wherein the fragment binds to a protein of the coronavirus.

5 . The method of claim 4 , wherein the second binding moiety comprises an anti-coronavirus antibody or fragment thereof, wherein the fragment binds to the a protein of coronavirus.

6 . The method of any one of claims 1 - 5 , wherein the anti-coronavirus antibody or fragment thereof binds to a spike protein, a nucleocapsid protein, an envelope protein, a membrane protein, or a hemagglutinin-esterase dimer protein of a coronavirus.

7 . The method of any one of claims 1 - 6 , wherein the first binding moiety is associated, e.g., covalently associated, with the detectable label.

8 . The method of any one of claims 1 - 6 , wherein the first binding moiety is associated, e.g., covalently associated, with the capture agent.

9 . The method of any one of claims 1 - 6 and 8 , wherein the second binding moiety is associated, e.g., covalently associated, with the detectable label.

10 . The method of any one of claims 1 - 9 , wherein the second binding moiety is associated, e.g., covalently associated, with the capture agent.

11 . The method of any one of claims 1 - 10 , wherein the detectable label comprises a fluorescent label, e.g., a fluorescent latex bead.

12 . The method of any one of claims 1 - 11 , wherein the capture agent comprises a magnetic bead.

13 . The method of any one of claims 1 - 12 , wherein the method is performed within a microfluidic device.

14 . The method of any one of claims 1 - 13 , wherein the coronavirus is SARS-CoV-2.

15 . The method of any one of claims 1 - 14 , wherein the sample comprises blood, serum, or plasma.

16 . The method of any one of claims 1 - 15 , wherein the sample is contacted with a latex particle prior to subjecting the sample to the double binding moiety sandwich assay.

17 . The method of any one of claims 1 - 16 , wherein the sample is contacted with a buffer comprising a salt solution prior to subjecting the sample to the double binding moiety sandwich assay.

18 . The method of any one of claims 16 - 17 , wherein, upon subjecting the sample to the double binding moiety sandwich assay, the presence of the coronavirus is detected.

19 . A microfluidic device for detecting a coronavirus in a sample from a subject, the device comprising:

a microchannel comprising a first and a second binding moiety dried within,

wherein the first binding moiety comprises a soluble ACE2 receptor, or a variant or fragment thereof, or an anti-coronavirus antibody,

wherein the first binding moiety is labeled with a detectable label or a capture agent, and

wherein the second binding moiety is attached to a detectable label or a capture agent, and

wherein the first and second binding moieties, when solubilized with the sample, form a complex comprising the first binding moiety, the coronavirus, and the second binding moiety.

20 . The microfluidic device of claim 19 , wherein the second binding moiety comprises a soluble ACE2 receptor, or a variant or fragment thereof.

21 . The microfluidic device of claim 19 or claim 20 , wherein the first and/or second binding moiety comprises an ACE2-Fc fusion protein.

22 . The method of any one of claim 19 - 21 , wherein the first binding moiety comprises an anti-coronavirus antibody or fragment thereof, wherein the fragment binds to the coronavirus.

23 . The microfluidic device of any one of claim 19 or 21 , wherein the second binding moiety comprises an anti-coronavirus antibody.

24 . The microfluidic device of any one of claims 19 - 23 , wherein the anti-coronavirus antibody or fragment thereof binds to a spike protein, a nucleocapsid protein, an envelope protein, a membrane protein, or a hemagglutinin-esterase dimer protein of a coronavirus.

25 . The microfluidic device of any one of claims 19 - 24 , wherein the anti-coronavirus antibody binds to a nucleocapsid protein.

26 . The microfluidic device of any one of claims 19 - 25 , wherein the first binding moiety is associated with, e.g., covalently associated, with the detectable label.

27 . The microfluidic device of any one of claims 19 - 25 , wherein the first binding moiety is associated, e.g., covalently associated, with the capture agent.

28 . The microfluidic device of any one of claims 19 - 25 and 27 , wherein the second binding moiety is associated, e.g., covalently associated, with the detectable label.

29 . The microfluidic device of any one of claims 19 - 27 , wherein the second binding moiety is associated, e.g., covalently associated, with the capture agent.

30 . The microfluidic device of any one of claims 19 - 29 , wherein the detectable label comprises a fluorescent label, e.g., a fluorescent latex bead.

31 . The microfluidic device of any one of claims 19 - 30 , wherein the capture agent comprises a magnetic bead.

32 . The microfluidic device of any one of claims 19 - 31 , wherein the coronavirus is SARS-CoV-2.

33 . The microfluidic device of any one of claims 19 - 32 , wherein the sample comprises blood, serum, or plasma.