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US 12,540,944 B2Granted
Recombinant amebocyte clotting factors and uses thereof
AssigneeCharles River Laboratories, Inc.
InventorsMasakazu Tsuchiya, Norman R. Wainwright
Life of this patent
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Abstract
Provided are recombinant amebocyte clotting factors, their formulation and use in determining the presence and/or amount of a microbial endotoxin in a sample. Also provided is a cartridge containing the recombinant amebocyte clotting factors for determining the presence and/or amount of a microbial endotoxin in a sample.
Claims24
A cartridge for bacterial endotoxin testing comprising:
- (a) a housing defining a fluid inlet port, an optical cell, and a conduit having a fluid contacting surface providing fluid flow communication between the fluid inlet port and the optical cell;
- (b) a first composition dried on a first region of the fluid contacting surface of the conduit;
- and
- (c) a second composition dried on a second region of the fluid contacting surface of the conduit;
- wherein the first region is spaced apart from the second region, such that, when a liquid sample is applied to the fluid inlet port, the sample traverses the first region and solubilizes the first composition, and then traverses the second region and solubilizes the second composition during transport to the optical cell;
- and
- wherein, the first and second compositions are selected from the group consisting of recombinant Factor B and recombinant Factor C, provided that the first composition is not the same as the second composition.
4 more elements
A cartridge for bacterial endotoxin testing comprising:
- (a) a housing defining a fluid inlet port, an optical cell, and a conduit having a fluid contacting surface providing fluid flow communication between the fluid inlet port and the optical cell;
- (b) (i) a first composition dried on a first region of the fluid contacting surface of the conduit, the first composition comprising recombinant Factor B, but not recombinant Factor C;
- and a second composition dried on a second region of the fluid contacting surface of the conduit, the second composition comprising recombinant Factor C and recombinant pro-clotting enzyme, but not recombinant Factor B;
- or
- (ii) a first composition dried on a first region of the fluid contacting surface of the conduit, the first composition comprising recombinant Factor C, but not recombinant Factor B;
- and a second composition dried on a second region of the fluid contacting surface of the conduit, the second composition comprising recombinant Factor B and recombinant pro-clotting enzyme, but not recombinant Factor C;
- and
- (c) a third composition dried on a third region of the fluid contacting surface of the conduit, the third composition comprising a chromogenic substrate;
- wherein the first region is spaced apart from the second region, such that, when a liquid sample is applied to the fluid inlet port, the sample traverses the first region and solubilizes the first composition, and then traverses the second region and solubilizes the second composition during transport to the optical cell;
- wherein the third region of the fluid contacting surface is positioned between the fluid inlet port and first region, and the second region is positioned on the cartridge or fluid contacting surface between the first region and the optical cell;
- wherein the recombinant factor B is a recombinant Limulus polyphemus factor B, the recombinant factor C is a recombinant Limulus polyphemus factor C, and the recombinant pro-clotting enzyme is a recombinant Limulus polyphemus pro-clotting enzyme.
8 more elements
Dependencies are inferred from the claim text.