Method and kit for the detection of biliary tract cancer

A method for detecting biliary tract cancer, the method comprising:

• determining an amount of an APOA2-ATQ protein and APOA2-AT protein present in a body fluid from a test subject and a normal subject by an immunological method using an anti-APOA2-ATQ terminus antibody which specifically binds to the C-terminal region of the APOA2-ATQ protein consisting of the amino acid sequence which is SEQ ID NO:
• 1, an anti-APOA2-AT terminus antibody which specifically binds to the C-terminal region of the APOA2- AT protein consisting of the amino acid sequence which is SEQ ID NO:
• 2, and an anti-APOA2 non-terminus antibody which binds to the amino acid sequence of the APOA2-ATQ protein or the APOA2-AT protein, excluding the its C-terminal region,
• wherein the determining process comprises the following steps (a) to (d):
• (a) contacting step of
• contacting the APOA2-ATQ protein present in body fluid of the test subject and the normal subject with the anti-APOA2-ATQ terminus antibody and the anti-APOA2 non-terminus antibody, and
• contacting the APOA2-AT protein present in body fluid of the test subject and the normal subject with the anti-APOA2-AT terminus antibody and the anti-APOA2 non-terminus antibody;
• (b) measuring step of measuring
• an amount of the APOA2-ATQ protein binding to both the anti-APOA2 non-terminus antibody and the anti-APOA2-ATQ terminus antibody and
• an amount of the APOA2-AT protein binding to both the anti-APOA2 non-terminus antibody and the anti-APOA2-AT terminus antibody;
• (c) inputting to a logistic regression equation for a discriminant value, the measurement of the amounts of the APOA2-ATQ protein and the amounts of the APOA2-AT protein obtained in the step (b) to obtain a discriminant value of the test subject;
• and
• (d) comparing the discriminant value of the test subject with that the normal subject to determine that the test subject is affected with biliary tract cancer when the discriminant value of the test subject is statistically significantly different with that of the normal subject,
• wherein the anti-APOA2-ATQ terminus antibody has
• the CDR1, CDR2 and CDR3 of the heavy chain consisting of the amino acid sequences which are SEQ ID NOs:
• 4, 5 and 6, respectively, and
• the CDR1, CDR2 and CDR3 of the light chain consisting of the amino acid sequences which are SEQ ID NOs:
• 7, 8 and 9, respectively;
• or
• the CDR1, CDR2and CDR3 of the heavy chain consisting of the amino acid sequences which are SEQ ID NOs:
• 10, 11 and 12, respectively, and
• the CDR1, CDR2 and CDR3 of the light chain consisting of the amino acid sequences which are SEQ ID NOs:
• 13, 14 and 15, respectively;
• and
• the anti-APOA2 non-terminus antibody has
• the CDR1, CDR2 and CDR3 of the heavy chain consisting of the amino acid sequences which are SEQ ID NOs:
• 16, 17 and 18 respectively, and
• the CDR1, CDR2 and CDR3 of the light chain consisting of the amino acid sequences which are SEQ ID NOs:
• 19, 20 and 21, respectively;
• or
• the CDR1, CDR2 and CDR3 of the heavy chain consisting of the amino acid sequences which are SEQ ID NOs:
• 22, 23 and 24, respectively, and
• the CDR1, CDR2 and CDR3 of the light chain consisting of the amino acid sequences which are SEQ ID NOs:
• 25, 26 and 27, respectively.