REAGENT FOR PROTHROMBIN TIME MEASUREMENT, METHOD FOR PRODUCTION THEREOF, AND METHOD FOR MEASUREMENT OF PROTHROMBIN TIME

• US 20170283853A1
• Filed: 03/29/2017
• Published: 10/05/2017
• Est. Priority Date: 03/30/2016
• Status: Active Grant

• Current Assignee: Sysmex Corporation
• Original Assignee: Sysmex Corporation
• Inventors: MICHISHITA, Masato, BANDO, Takahiko, TANAKA, Yusuke, KOHAMA, Kiyoko
• Granted Patent: US 10,640,805 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: C12Q 1/56 involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
• CPC Class Codes: G01N 2333/7454 Tissue factor (tissue thromboplastin, Factor III)
• CPC Class Codes: G01N 2333/974 Thrombin
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

Disclosed is a reagent for prothrombin time measurement, containing a tissue factor and a surfactant, wherein the value of formula (I), which is represented by (surfactant amount (μmol))/(total protein amount (μg)), is 0.013 to 0.05 μmol/μg.

Claims

1. A reagent for prothrombin time measurement, comprising a tissue factor and a surfactant, wherein the value of formula (I), which is represented by (surfactant amount (μ

mol))/(total protein amount (μ

g)), is 0.013 to 0.05 μ

mol/μ

g.

2. The reagent according to claim 1, wherein the surfactant is a nonionic surfactant.

3. The reagent according to claim 2, wherein the nonionic surfactant is an alkylglucoside surfactant or an acylalkylglucamine surfactant.

4. The reagent according to claim 3, wherein the alkylglucoside surfactant is an alkylglucoside compound in which an alkyl group has 6 to 10 carbon atoms.

5. The reagent according to claim 3, wherein the acylalkylglucamine surfactant is an alkanoyl methylglucamine compound in which an alkanoyl group has 7 to 9 carbon atoms.

6. The reagent according to claim 1, wherein the tissue factor is a recombinant tissue factor.

7. The reagent according to claim 6, wherein the recombinant tissue factor is a recombinant human tissue factor.

8. The reagent according to claim 1, further comprising calcium ions.

9. The reagent according to claim 1, further comprising a phospholipid.

10. The reagent according to claim 1, wherein the reagent is a lyophilizate, or a solution of the lyophilizate dissolved in a solvent.

11. A method for producing a reagent for prothrombin time measurement, comprising a step of freeze-drying an aqueous solution containing a tissue factor and a surfactant, wherein the value of formula (I), which is represented by (surfactant amount (μ

mol))/(total protein amount (μ

g)), is 0.013 to 0.05 μ

mol/μ

g, thereby to obtain a lyophilizate.

12. The method according to claim 11, further comprising a step of dissolving the lyophilizate in a solvent.

13. The method according to claim 11, wherein the surfactant is a nonionic surfactant.

14. The method according to claim 13, wherein the nonionic surfactant is an alkylglucoside surfactant or an acylalkylglucamine surfactant.

15. The method according to claim 13, wherein the alkylglucoside surfactant is an alkylglucoside compound in which an alkyl group has 6 to 10 carbon atoms.

16. The method according to claim 11, wherein the tissue factor is a recombinant tissue factor.

17. The method according to claim 16, wherein the recombinant tissue factor is a recombinant human tissue factor.

18. The method according to claim 11, further comprising calcium ions.

19. The method according to claim 11, further comprising a phospholipid.

20. A method for measuring prothrombin time, comprising steps of:

(a) contacting a reagent for prothrombin time measurement with a sample of blood, thereby to obtain a measurement sample, and

(b) measuring the prothrombin time of the measurement sample, wherein

the reagent comprising a tissue factor and a surfactant, wherein the value of formula (I), which is represented by (surfactant amount (μ

mol))/(total protein amount (μ

g)), is 0.013 to 0.05 μ

mol/μ

.