Patent ID: 11913956
Assignee: SHANDONG ZEJI BIOTECHNOLOGY CO., LTD.
Field: Measurement (Instruments)
Classification: CPC G  C | IPC G

Claim 0:
1. A method for tumor screening and evaluating risk of tumor development, comprising:
obtaining a blood sample from a subject;
determining a concentration of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH) in the blood sample by a sandwich enzyme-linked immunosorbent assay (ELISA);
detecting a concentration of at least one additional tumor marker in the blood sample, wherein the at least one additional tumor marker comprises alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), carbohydrate antigen 72-4 (CA72-4), carbohydrate antigen 242 (CA242), cytokeratin-19-fragment (CYFRA21-1), and alpha-1-fucosidase (AFU); and
comparing the concentration of GAPDH in the blood sample with a first reference concentration, and comparing the concentration of the at least one additional tumor marker in the blood sample with a second reference concentration,
wherein when the concentration of GAPDH in the blood sample is greater than or equal to the first reference concentration and the concentration of the at least one additional tumor marker in the blood sample is greater than the second reference concentration, the subject is determined as a tumor patient or having a risk of developing a tumor,
wherein the first reference concentration of 5.95 μg/ml and the second reference concentration of AFP of 400 ng/ml are used to determine whether the subject has liver cancer or is at risk of developing liver cancer,
wherein the first reference concentration of 10.58 μg/ml and the second reference concentration of CYFRA21-1 of 3.15 ng/l are used to determine whether the subject has lung cancer or is at risk of developing lung cancer,
wherein the first reference concentration of 5.57 μg/ml, the second reference concentration of CEA of 5 ng/ml, the second reference concentration of CA19-9 of 37 U/ml and the second reference concentration of CA72-4 of 6.9 U/ml are used to determine whether the subject has gastric cancer or is at risk of developing gastric cancer,
wherein the first reference concentration of 11.75 μg/ml, the second reference concentration of CEA of 5 ng/ml and the second reference concentration of AFU of 5.6 U/l are used to determine whether the subject has colorectal cancer or is at risk of developing colorectal cancer,
wherein the first reference concentration of 5.94 μg/ml and the second reference concentration of CA19-9 of 37 U/ml and/or CA242 of 20 U/ml are used to determine whether the subject has pancreatic cancer or a risk of developing pancreatic cancer,
wherein an amino acid sequence of GAPDH is shown as SEQ ID No. 1, the sandwich ELISA is performed by a capture antibody and a detection antibody, the capture antibody binds to N-terminal amino acids 40-160 of the GAPDH amino acid sequence for capturing GAPDH from the blood sample, and the detection antibody binds to N-terminal amino acids 180-335 of the GAPDH amino acid sequence for measuring the concentration of GAPDH,
wherein the capture antibody comprises heavy chain variable region and light chain variable region, the heavy chain variable region comprises CDR1 shown as SEQ ID No. 2, CDR2 shown as SEQ ID No. 3 and CDR3 shown as SEQ ID No. 4, the light chain variable region comprises CDR1 shown as SEQ ID No. 5, CDR2 shown as SEQ ID No. 6 and CDR3 shown as SEQ ID No. 7,
wherein the detection antibody comprises heavy chain variable region and light chain variable region, the heavy chain variable region comprises CDR1 shown as SEQ ID No. 8, CDR2 shown as SEQ ID No. 9 and CDR3 shown as SEQ ID No. 10, the light chain variable region comprises CDR1 shown as SEQ ID No. 11, CDR2 shown as SEQ ID No. 12 and CDR3 shown as SEQ ID No. 13.