# US 2014/0154698 A1 · Methods for measuring carcinoembryonic antigen > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154698 A1 - Document ID: US20140154698A1 - Status: Published application - Kind: A1 - Application number: 14/092,036 - Filed: 2013-11-27 - Published: 2014-06-05 - Earliest claimed: 2012-11-30 - Assignees: RedPath Integrated Pathology, Inc. - Applicants: RedPath Integrated Pathology, Inc - Inventors: Sydney David Finkelstein; Sara Ann Jackson; Jamie Michelle Bleicher; Eric Matthew Gayle Ellsworth; Dennis Morgan Smith, JR. - Web page: https://patentgrep.com/patent/US20140154698A1 ## CPC - G01N 33/57565: {involving carcinoembryonic antigen [CEA]} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Disclosed herein are methods of accurately measuring carcinoembryonic antigen in a biological sample and methods of identifying and treating a mucinous cyst in a subject. ## Claims ### Claim 1 A method of accurately measuring carcinoembryonic antigen in a biological sample, the method comprising: diluting the biological sample to form a diluted sample when an amylase level in the biological sample is less than a pre-determined amylase threshold between about 10,000 and about 20,000 units; wherein diluting the biological sample comprises diluting the biological sample with a diluent in a ratio of biological sample to diluent of between about 1:10 and about 1:50; and measuring carcinoembryonic antigen in the diluted sample. ### Claim 2 (depends on 1) The method of claim 1, further comprising measuring amylase level in a biological sample. ### Claim 3 (depends on 1) The method of claim 1, wherein the biological sample is undiluted. ### Claim 4 (depends on 1) The method of claim 1, wherein the diluent is saline, Diluent Universal, or a combination thereof. ### Claim 5 (depends on 1) The method of claim 1, wherein the pre-determined amylase threshold is about 10,000 units, about 15,000 units, or about 20,000 units. ### Claim 6 (depends on 1) The method of claim 1, wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of biological sample to diluent of about 1:40. ### Claim 7 (depends on 1) The method of claim 1, wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of biological sample to diluent of about 1:10. ### Claim 8 (depends on 1) The method of claim 1, wherein the biological sample is not present in sufficient volume to accurately measure carcinoembryonic antigen levels. ### Claim 9 (depends on 1) The method of claim 1, wherein the biological sample has a high viscosity. ### Claim 10 (depends on 9) The method of claim 9, wherein the high viscosity is due to the presence of mucin in the biological sample. ### Claim 11 (depends on 1) The method of claim 1, wherein the carcinoembryonic antigen levels in the biological sample exceed the measurement capabilities of an instrument being used to measure carcinoembryonic antigen levels. ### Claim 12 (depends on 1) The method of claim 1, wherein the biological sample is selected from pancreatic fluid, pancreatic cyst fluid and combinations thereof. ### Claim 13 (depends on 1) The method of claim 1, wherein the presence of carcinoembryonic antigen above a predetermined carcinoembryonic antigen threshold in the saline diluted sample is indicative of a pathological condition. ### Claim 14 (depends on 13) The method of claim 13, wherein the carcinoembryonic antigen level threshold is about 192 ng/ml, or about 400 ng/ml. ### Claim 15 (depends on 13) The method of claim 13, wherein the pathological condition is selected from a neoplastic condition, a non-neoplastic condition and a combination thereof. ### Claim 16 (depends on 15) The method of claim 15, wherein the neoplastic condition is selected from colorectal carcinoma, gastric carcinoma, pancreatic carcinoma, cholangiocarcinoma, intraductal papillary mucinous neoplasm (IPMN), lung carcinoma, breast carcinoma, medullary thyroid carcinoma, and combinations thereof. ### Claim 17 (depends on 15) The method of claim 15, wherein the non-neoplastic condition is selected from ulcerative colitis, pancreatitis, pancreatic cysts, pancreatic masses, biliary strictures, cirrhosis, chronic obstructive pulmonary disease, Crohn's disease, intraductal papillary mucinous neoplasm (IPMN), and combinations thereof. ### Claim 18 A method of accurately measuring carcinoembryonic antigen in a biological sample, the method comprising: diluting the biological sample with a diluent at a ratio of biological sample to diluent of about 1:10 to about 1:50 to form a diluted biological sample, wherein the amylase level in the biological sample is greater than a pre-determined amylase threshold between about10,000 and about 20,000 units; measuring carcinoembryonic antigen level in the diluted biological sample; multiplying the carcinoembryonic antigen level by a correction factor to obtain a corrected carcinoembryonic antigen level. ### Claim 19 (depends on 18) The method of claim 18, further comprising measuring amylase levels in a biological sample. ### Claim 20 (depends on 18) The method of claim 18, wherein the diluent is saline, Diluent Universal, or a combination thereof. ### Claim 21 (depends on 18) The method of claim 18, wherein the biological sample is undiluted. ### Claim 22 (depends on 18) The method of claim 18, wherein the pre-determined amylase threshold is about 10,000 units, about 15,000 units, or about 20,000 units. ### Claim 23 (depends on 18) The method of claim 18, wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of about 1:10. ### Claim 24 (depends on 18) The method of claim 18, wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of about 1:40. ### Claim 25 (depends on 18) The method of claim 18, wherein the correction factor is about 0.7. ### Claim 26 (depends on 18) The method of claim 18, wherein the biological sample is not present in sufficient volume to accurately measure carcinoembryonic antigen level. ### Claim 27 (depends on 18) The method of claim 18, wherein the biological sample has a high viscosity. ### Claim 28 (depends on 27) The method of claim 27, wherein the high viscosity is due to the presence of mucin in the biological sample. ### Claim 29 (depends on 18) The method of claim 18, wherein the carcinoembryonic antigen levels in the biological sample exceed the measurement capabilities of an instrument being used to measure carcinoembryonic antigen level. ### Claim 30 (depends on 18) The method of claim 18, wherein the biological sample is selected from pancreatic fluid, pancreatic cyst fluid and combinations thereof. ### Claim 31 (depends on 18) The method of claim 18, wherein a corrected carcinoembryonic antigen level above a predetermined carcinoembryonic antigen threshold is indicative of a pathological condition. ### Claim 32 (depends on 31) The method of claim 31, wherein the carcinoembryonic antigen level threshold is about 192 ng/ml, or about 400 ng/ml. ### Claim 33 (depends on 31) The method of claim 31, wherein the pathological condition is selected from a neoplastic condition, a non-neoplastic condition and a combination thereof. ### Claim 34 (depends on 33) The method of claim 33, wherein the neoplastic condition is selected from colorectal carcinoma, gastric carcinoma, cholangiocarcinoma, pancreatic carcinoma, intraductal papillary mucinous neoplasm (IPMN), lung carcinoma, breast carcinoma, medullary thyroid carcinoma, and combinations thereof. ### Claim 35 (depends on 33) The method of claim 33, wherein the non-neoplastic condition is selected from ulcerative colitis, pancreatitis, pancreatic cysts, pancreatic masses, biliary strictures, cirrhosis, chronic obstructive pulmonary disease, Crohn's disease, intraductal papillary mucinous neoplasm (IPMN), and combinations thereof. ### Claim 36 A method of identifying a mucinous cyst in a subject, the method comprising: diluting the biological sample with a diluent when an amylase level in the biological sample is less than a pre-determined amylase threshold between about 10,000 and about 20,000 units, to form a diluted sample, wherein diluting the biological sample with a diluent comprises diluting the biological sample in a ratio of biological sample to diluent between about 1:10 and about 1:50; and measuring carcinoembryonic antigen level in the saline diluted sample; wherein a carcinoembryonic antigen level above a predetermined carcinoembryonic antigen level threshold in the diluted sample is indicative of a mucinous cyst. ### Claim 37 (depends on 36) The method of claim 36, further comprising obtaining a biological sample from the subject. ### Claim 38 (depends on 36) The method of claim 36, wherein the diluent is saline, Diluent Universal, or a combination thereof. ### Claim 39 (depends on 36) The method of claim 36, further comprising measuring amylase levels in a biological sample. ### Claim 40 (depends on 36) The method of claim 36, wherein the biological sample is undiluted. ### Claim 41 (depends on 36) The method of claim 36, wherein the pre-determined amylase threshold is about 10,000 units, about 15,000 units, or about 20,000 units. ### Claim 42 (depends on 36) The method of claim 36, wherein diluting the biological sample with a diluent comprises diluting the biological with a diluent in a ratio of about 1:40. ### Claim 43 (depends on 36) The method of claim 36, wherein diluting the biological sample with a diluent comprises diluting the biological sample with a diluent in a ratio of about 1:10. ### Claim 44 (depends on 36) The method of claim 36, wherein the biological sample is not present in sufficient volume to accurately measure carcinoembryonic antigen levels. ### Claim 45 (depends on 36) The method of claim 36, wherein the biological sample has a high viscosity. ### Claim 46 (depends on 45) The method of claim 45, wherein the high viscosity is due to the presence of mucin in the neat biological sample. ### Claim 47 (depends on 36) The method of claim 36, wherein the carcinoembryonic antigen levels in the biological sample exceed the measurement capabilities of an instrument being used to measure carcinoembryonic antigen. ### Claim 48 (depends on 36) The method of claim 36, wherein the biological sample is selected from pancreatic fluid, pancreatic cyst fluid and combinations thereof. ### Claim 49 (depends on 36) The method of claim 36, wherein the carcinoembryonic antigen level threshold is about 192 ng/ml, or about 400 ng/ml. ### Claim 50 A method of identifying a mucinous cyst in a subject, the method comprising: diluting the biological sample with a diluent at a ratio of biological sample to diluent of about 1:10 to about 1:50 to form a diluted biological sample, wherein the amylase levels in the biological sample are greater than a pre-determined amylase threshold between about 10,000 and about 20,000 units; measuring carcinoembryonic antigen level in the diluted biological sample; multiplying the carcinoembryonic antigen level of the diluted biological sample by a correction factor to obtain a corrected carcinoembryonic antigen level; and wherein a corrected carcinoembryonic antigen level of above a predetermined carcinoembryonic antigen threshold is indicative of a mucinous cyst. ### Claim 51 (depends on 50) The method of claim 50, further comprising obtaining a biological sample from the subject. ### Claim 52 (depends on 50) The method of claim 50, further comprising measuring amylase levels in a biological sample. ### Claim 53 (depends on 50) The method of claim 50, wherein the biological sample is undiluted. ### Claim 54 (depends on 50) The method of claim 50, wherein the pre-determined amylase threshold is about 10,000 units, about 15,000 units, or about 20,000 units. ### Claim 55 (depends on 50) The method of claim 50, wherein diluting the biological sample with a diluent comprises diluting the biological sample in a ratio of biological sample to diluent of about 1:10. ### Claim 56 (depends on 50) The method of claim 50, wherein diluting the biological sample with a diluent comprises diluting the biological sample in a ratio of biological sample to diluent of about 1:40. ### Claim 57 (depends on 50) The method of claim 50, wherein the correction factor is about 0.7. ### Claim 58 (depends on 50) The method of claim 50, wherein the biological sample is not present in sufficient volume to accurately measure carcinoembryonic antigen. ### Claim 59 (depends on 50) The method of claim 50, wherein the biological sample has a high viscosity. ### Claim 60 (depends on 59) The method of claim 59, wherein the high viscosity is due to the presence of mucin in the neat biological sample. ### Claim 61 (depends on 50) The method of claim 50, wherein the carcinoembryonic antigen level in the biological sample exceed the measurement capabilities of an instrument being used to measure carcinoembryonic antigen. ### Claim 62 (depends on 50) The method of claim 50, wherein the biological sample is selected from pancreatic fluid, pancreatic cyst fluid and combinations thereof. ### Claim 63 (depends on 50) The method of claim 50, wherein the carcinoembryonic antigen level threshold is about 192 ng/ml or about 400 ng/ml.