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US 2025/0085289 A1Published application
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.
Claims19
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 disposed on a first region of the fluid contacting surface of the conduit;
- and
- (c) a second composition disposed 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 the second region and solubilizes the first and second compositions, 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.
3 more elements
A cartridge for detecting bacterial endotoxin in a sample 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 chromogenic substrate disposed on a first region of the fluid contacting surface of the conduit;
- (c) a first recombinant amebocyte factor disposed on a second region of the fluid contacting surface of the conduit, and
- (d) a second recombinant amebocyte factor disposed on a third region of the fluid contacting surface;
- wherein the second region is spaced apart from and downstream of the first region in the direction of fluid flow along the conduit, and the third region is spaced apart from and downstream of the second region and the first region in the direction of fluid flow along the conduit;
- and
- wherein (i) the first recombinant amebocyte factor comprises recombinant Factor B, and the second recombinant amebocyte factor comprises recombinant Factor C, and recombinant pro-clotting enzyme is disposed on the third region with the recombinant Factor C;
- or (ii) the first recombinant amebocyte factor comprises recombinant Factor C and the second recombinant amebocyte factor comprises recombinant Factor B, and recombinant pro-clotting enzyme is disposed on the second region with the recombinant Factor C.
5 more elements
A method of producing a bacterial endotoxin testing composition, the method comprising:
- (a) providing a first composition comprising recombinant Factor C, but free of Factor B;
- (b) providing a second composition comprising recombinant Factor B, but free of Factor C;
- and
- (c) mixing the first composition with the second composition in the presence of recombinant pro-clotting enzyme to form a third composition, wherein
- (i) the first and second compositions remain separated until mixed together immediately prior to contact with a test sample;
- or
- (ii) the first and second compositions remain separated until mixed with a test sample.
4 more elements
A kit for determining the presence and/or amount of a bacterial endotoxin in a test sample, the kit comprising:
- (a) a first composition comprising recombinant Factor C, which is free of recombinant Factor B;
- (b) a second composition comprising a recombinant Factor B, which is free of recombinant Factor C, wherein the first and second compositions are physically separated;
- and
- (c) a means for mixing the first and second compositions together in the presence of recombinant pro-clotting enzyme and a chromogenic substrate immediately prior to, or simultaneous with, contact with a test sample.
1 more element
Dependencies are inferred from the claim text.