IP Library › Granted Patent US 10,000,791
Granted Patent B2
US 10,000,791 · App. 14/775,919 · Granted Jun 19, 2018

Measurement method for human pancreatic lipase activity

Inventors: Shigeru Ueda (Tokyo, JP); Shinichi Sakasegawa (Tokyo, JP)
Assignee: ASAHI KASEI PHARMA CORPORATION
C12Q1/44G01N2333/92
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Quick Facts
Patent No.
US 10,000,791
App. No.
14/775,919
Granted
Jun 19, 2018
Kind
B2
Abstract

A measurement method for human pancreatic lipase activity in a sample, includes bringing a bile acid that makes a pH for giving a maximum value of human pancreatic lipase activity to be lower than 7.7, a diglyceride and a colipase into contact with the sample at pH 7.4 or lower; and detecting a signal amount varying in accordance with the human pancreatic lipase activity in the sample, and the bile acid is a bile acid containing: one of or two or more of a-type bile acids selected from the group consisting of GDCA, GCDCA, TDCA, TCDCA and salts thereof; and/or a combination of one of or two or more of b-1-type bile acids selected from the group consisting of GCA, GUDCA, TCA, TUDCA and salts thereof, and one of or two or more of b-2-type bile acids selected from the group consisting of DCA, CDCA and salts thereof.

Claims (39)

1. A measurement method for human pancreatic lipase activity in a blood sample, comprising:

1) maximizing the activity of human pancreatic lipase in the blood sample and decreasing the activity of human non-pancreatic lipase in the blood sample by bringing a bile acid that makes a pH for giving a maximum value of the human pancreatic lipase activity to be lower than 7.7, a diglyceride and a colipase into contact with the sample at pH 7.4 or lower; and

2) detecting a signal amount varying in accordance with the human pancreatic lipase activity in the sample,

wherein the bile acid is a bile acid comprising:

a) at least one a-type bile acid which is glycodeoxycholic acid (GDCA), glycochenodeoxycholic acid (GCDCA), taurodeoxycholic acid (TDCA), taurochenodeoxycholic acid (TCDCA), or a salt thereof; and/or

b) at least one b-i-type bile acid which is glycocholic acid (GCA), glycoursodeoxycholic acid (GUDCA), taurocholic acid (TCA), tauroursodeoxycholic acid (TUDCA), or a salt thereof, and at least one b-2-type bile acid which is deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), or a salt thereof, and

wherein when the bile acid(s) of a) is used, an addition rate of the a-type bile acid(s) is 40% or more based on a total amount of all bile acids and/or salts thereof.

2. The measurement method according to claim 1 , wherein the bile acid(s) of a) is used in said contact.

3. The measurement method according to claim 1 , wherein the bile acid(s) of b) is used in said contact.

4. The measurement method according to claim 1 , wherein the a-type bile acid(s) is glycodeoxycholic acid (GDCA), GDCA and a salt thereof, a salt of GDCA, or two salts of GDCA.

5. The measurement method according to claim 1 , wherein the a-type bile acid(s) is at least one of glycodeoxycholic acid (GDCA), taurodeoxycholic acid (TDCA), or salts thereof.

6. The measurement method according to claim 1 , wherein the a-type bile acid(s) is taurodeoxycholic acid (TDCA)), TDCA and a salt thereof, a salt of TDCA, or two salts of TDCA.

7. The measurement method according to claim 1 , wherein a non-ionic surface active agent is present together with the diglyceride.

8. The measurement method according to claim 7 , wherein the non-ionic surface active agent is at least one of polyoxyethylene alkyl ether, polyoxyethylene alkyl phenyl ether, or polyoxyethylene secondary alcohol ether.

9. The measurement method according to claim 1 , wherein a colorimetric method is employed in said detection.

10. The measurement method according to claim 1 , wherein a concentration of all bile acids is ten times or more as high as a concentration of the diglyceride in terms of a molar ratio during said contact.

11. The measurement method according to claim 1 , wherein the pH is 7.2 or lower during said contact.

12. The measurement method according to claim 1 , wherein the blood sample is taken from an individual in need of diagnosis for pancreatic disease, and wherein the measurement method further comprises:

3) diagnosing the individual in need of diagnosis of pancreatic disease as having pancreatic disease from the detected signal amount.

13. The measurement method according to claim 1 , wherein the blood sample is contaminated with a human non-pancreatic lipase and is from a heparin-administered individual.

14. A measurement method for human pancreatic lipase activity in a blood sample, comprising:

1) maximizing the activity of human pancreatic lipase in the blood sample and decreasing the activity of human non-pancreatic lipase in the blood sample by bringing a bile acid, a diglyceride and a colipase into contact with the sample at pH 7.4 or lower; and

2) detecting a signal amount varying in accordance with the human pancreatic lipase activity in the sample,

wherein a concentration of the diglyceride is 0.35 to 2.5 mmol/L, and a concentration of the bile acid is ten to twenty times as high as the concentration of the diglyceride in terms of a molar ratio, and the bile acid is:

a) at least one a-type bile acid which is glycodeoxycholic acid (GDCA), glycochenodeoxycholic acid (GCDCA), taurodeoxycholic acid (TDCA), taurochenodeoxycholic acid (TCDCA), or salts thereof, a molar ratio of the a-type bile acid(s) being 40% or more based on a total amount of all bile acids and/or salts thereof; and/or

b) at least one b-i-type bile acid which is glycocholic acid (GCA), glycoursodeoxycholic acid (GUDCA), taurocholic acid (TCA), tauroursodeoxycholic acid (TUDCA), or salts thereof, and at least one b-2-type bile acid which is deoxycholic acid (DCA), chenodeoxycholic acid (CDCA), or salts thereof, a molar ratio of the b-1-type bile acid(s) being 30 to 70% based on the total amount of all the bile acids and/or salts thereof, and

wherein when the bile acid(s) of a) is used, an addition rate of the a-type bile acid(s) is 40% or more based on a total amount of all bile acids and/or salts thereof.

15. The measurement method according to claim 14 , wherein the bile acid(s) of a) is used in said contact.

16. The measurement method according to claim 14 , wherein the bile acid(s) of b) is used in said contact.

17. The measurement method according to claim 14 , wherein the a-type bile acid(s) is glycodeoxycholic acid (GDCA), GDCA and a salt thereof, a salt of GDCA, or two salts of GDCA.

18. The measurement method according to claim 14 , wherein the a-type bile acid(s) is at least one of glycodeoxycholic acid (GDCA), taurodeoxycholic acid (TDCA), or salts thereof.

19. The measurement method according to claim 14 , wherein the a-type bile acid(s) is taurodeoxycholic acid (TDCA), TDCA and a salt thereof, a salt of TDCA, or two salts of TDCA.

20. The measurement method according to claim 14 , wherein a non-ionic surface active agent is present together with the diglyceride.

21. The measurement method according to claim 20 , wherein the non-ionic surface active agent is at least one of polyoxyethylene alkyl ether, polyoxyethylene alkyl phenyl ether, and polyoxyethylene secondary alcohol ether.

22. The measurement method according to claim 14 , wherein a colorimetric method is employed in said detection.

23. The measurement method according to claim 14 , wherein the pH is 7.2 or lower in said contact.

24. The measurement method according to claim 14 , wherein the blood sample is taken from an individual in need of diagnosis for pancreatic disease, and wherein the measurement method further comprises:

3) diagnosing the individual in need of diagnosis of pancreatic disease as having pancreatic disease from the detected signal amount.

25. The measurement method according to claim 14 , wherein the blood sample is contaminated with a human non-pancreatic lipase and is from a heparin-administered individual.

Assignments (2)
NUNC PRO TUNC ASSIGNMENT Recorded Dec 1, 2025
From: ASAHI KASEI PHARMA CORPORATION
To: NAGASE DIAGNOSTICS CO., LTD.
Reel/Frame 073061/0129 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 14, 2015
From: UEDA, SHIGERU; SAKASEGAWA, SHINICHI
To: ASAHI KASEI PHARMA CORPORATION
Reel/Frame 036556/0584 →
Priority Claims (1)
JP 2013-087665 · Apr 18, 2013 · national
Continuity (1)
Related Publication 20160024553A1 · Jan 28, 2016