US 12,467,926 B2
Method for determining immune competence against severe acute respiratory syndrome coronavirus 2
Shin-Ru Shih, New Taipei (TW); Kuan-Ting Liu, Taoyuan (TW); Guang-Wu Chen, New Taipei (TW); Chung-Guei Huang, Taoyuan (TW); Kar-Yee Yu, Taoyuan (TW); Hou-Chen Lee, Taoyuan (TW); Peng-Nien Huang, Taoyuan (TW); Yu-Nong Gong, Taoyuan (TW); Rei-Lin Kuo, Taoyuan (TW); Chih-Ching Wu, Taoyuan (TW); Yu-An Kung, Taoyuan (TW); and Sheng-Yu Huang, Taoyuan (TW)
Assigned to CHANG GUNG UNIVERSITY, Taoyuan (TW); and Chang Gung Memorial Hospital, Linkou, Taoyuan (TW)
Filed by CHANG GUNG UNIVERSITY, Taoyuan (TW); and Chang Gung Memorial Hospital, Linkou, Taoyuan (TW)
Filed on Sep. 9, 2021, as Appl. No. 17/470,283.
Claims priority of provisional application 63/076,533, filed on Sep. 10, 2020.
Prior Publication US 2022/0074939 A1, Mar. 10, 2022
Int. Cl. A61K 39/215 (2006.01); G01N 33/538 (2006.01); G01N 33/543 (2006.01); G01N 33/569 (2006.01); G06N 7/00 (2023.01)
CPC G01N 33/56983 (2013.01) [G01N 33/538 (2013.01); G01N 33/54366 (2013.01); G01N 2800/26 (2013.01); G06N 7/00 (2013.01)] 4 Claims
 
1. A method for determining immune competence against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), comprising:
obtaining a blood sample from a test subject in need thereof;
detecting, in the blood sample, titers of binding antibodies against SARS-CoV-2 spike subunit 1 (S1) protein and receptor binding domain (RBD) protein thereof;
calculating an estimated value of a neutralizing antibody titer against SARS-CoV-2 by substituting the titers of the binding antibodies into a linear regression model having the following equation (I):
A=−0.4306+0.4121×B+2.8792×C  (I)
where A=estimated value of neutralizing antibody titer against SARS-CoV-2
B=binding antibody titer against S1 protein
C=binding antibody titer against RBD protein;
comparing the estimated value of the neutralizing antibody titer against SARS-CoV-2 with a predetermined standard obtained from a subject having protective immunity or sterilizing immunity against SARS-CoV-2,
wherein when the estimated value of the neutralizing antibody titer against SARS-CoV-2 is less than the predetermined standard, the test subject is determined as having an insufficient neutralizing antibody titer against SARS-CoV-2 which is indicative of having neither protective immunity nor sterilizing immunity against SARS-CoV-2; and
inoculating the test subject having neither protective immunity nor sterilizing immunity against SARS-CoV-2 with a vaccine against a SARS-CoV-2 variant, thereby increasing the test subject's immune competence.