US 12,270,806 B2
Rapid assay for detection of SARS-CoV-2 antibodies
Hans Haecker, Salt Lake City, UT (US); and Vanessa Redecke, Salt Lake City, UT (US)
Assigned to UNIVERSITY OF UTAH RESEARCH FOUNDATION, Salt Lake City, UT (US)
Filed by UNIVERSITY OF UTAH RESEARCH FOUNDATION, Salt Lake City, UT (US)
Filed on Jul. 12, 2022, as Appl. No. 17/862,666.
Application 17/478,527 is a division of application No. 17/140,321, filed on Jan. 4, 2021, granted, now 11,175,293, issued on Nov. 16, 2021.
Application 17/862,666 is a continuation of application No. 17/478,527, filed on Sep. 17, 2021, granted, now 11,467,165.
Prior Publication US 2023/0025108 A1, Jan. 26, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. C07K 14/165 (2006.01); C07K 14/47 (2006.01); C07K 16/10 (2006.01); C07K 16/30 (2006.01); G01N 33/49 (2006.01); G01N 33/68 (2006.01)
CPC G01N 33/49 (2013.01) [C07K 14/165 (2013.01); C07K 14/47 (2013.01); C07K 16/1003 (2023.08); C07K 16/3061 (2013.01); G01N 33/68 (2013.01); C07K 2319/02 (2013.01); C07K 2319/30 (2013.01); C07K 2319/73 (2013.01)] 19 Claims
 
1. A method for evaluating whether a subject is infected or has been infected with SARS-CoV-2, the method comprising:
(a) providing a sample of a biological fluid from a subject in need of diagnosis;
(b) combining the biological fluid with one or more diagnostic or control polypeptide comprising:
a diagnostic polypeptide comprising one or more of a polypeptide sequence of SEQ ID NO: 22 and one or more SARS COV-2 virus protein domains (CVD) selected from one or more of a spike protein, a nucleocapsid protein, an ORF8 protein, an ORF3b protein, or an envelope protein;
a control polypeptide comprising one or more of:
(i) a glycophorin A-binding nanobody domain comprising the polypeptide sequence of SEQ ID NO: 14; or
(ii) one or more anti-SARS Co-V-2 nanobody domains comprising a polypeptide sequence having at least 90-99% identity to SEQ ID NO: 32 and one or more multimerization domains comprising a polypeptide sequence having at least 90-99% identity to SEQ ID NO: 34 or 36;
(c) permitting the subject sample and control samples to incubate for a period of time;
(d) evaluating the results by visualization, imaging, optical density, impedance, or microscopy; and
wherein the presence of hemagglutination in the subject sample is a positive diagnostic indication of SARS-CoV-2 infection, and the absence of hemagglutination in the subject sample is a negative diagnostic indication of SARS-CoV-2 infection.