US 11,718,662 B2
Rep protein as protein antigen for use in diagnostic assays
Harald Zur Hausen, Waldmichelbach (DE); Ethel-Michele De Villiers-Zur Hausen, Waldmichelbach (DE); Timo Bund, Dossenheim (DE); and Sebastian Eilebrecht, Eslohe (DE)
Assigned to DEUTSCHES KREBSFORSCHUNGSZENTRUM STIFTUNG DES ÖFFENTLICHEN RECHTS, Heidelberg (DE)
Filed by DEUTSCHES KREBSFORSCHUNGSZENTRUM STIFTUNG DES OFFENTLICHEN RECHTS, Heidelberg (DE)
Filed on Apr. 5, 2019, as Appl. No. 16/376,154.
Application 16/376,154 is a continuation in part of application No. PCT/EP2017/075774, filed on Oct. 10, 2017.
Claims priority of application No. 16193119 (EP), filed on Oct. 10, 2016.
Prior Publication US 2019/0270795 A1, Sep. 5, 2019
Int. Cl. G01N 33/543 (2006.01); C07K 16/18 (2006.01); G01N 33/563 (2006.01); G01N 33/577 (2006.01); G01N 33/68 (2006.01); G01N 33/53 (2006.01); G01N 33/564 (2006.01); G01N 33/50 (2006.01)
CPC C07K 16/18 (2013.01) [G01N 33/502 (2013.01); G01N 33/53 (2013.01); G01N 33/563 (2013.01); G01N 33/564 (2013.01); G01N 33/577 (2013.01); G01N 33/6857 (2013.01); G01N 2496/80 (2013.01); G01N 2800/285 (2013.01)] 12 Claims
 
1. A method of diagnosing multiple sclerosis (MS) in a human patient comprising the steps of
(a) incubating a sample from the human patient selected from the group consisting of blood, serum and plasma with a DNA-replication-associated (Rep) protein comprising,
(i) the amino acid sequence as depicted in SEQ ID NOS: 1 or 14; or
(ii) a fragment of the amino acid sequence as depicted in SEQ ID NO: 1 and the fragment consists of the amino acid selected from the group consisting of the amino acids 1 to 136 or 137 to 229 of SEQ ID NO:1 and SEQ ID NOS: 2, 3 or 9;
(b) detecting the amount of antibodies in the sample from the human patient forming an immunological complex with the Rep protein;
(c) determining the extent of difference in the amount of antibodies present in the sample from the human patient and a control sample taken from a healthy individual who has not been diagnosed for MS; and
(d) diagnosing MS, when the amount of antibodies bound to Rep protein in the sample from the human patient is at least 2-fold increased, as compared to the amount in the control sample.