The invention provides methods and compositions for the detection and/or quantification of a microbial contaminant, for example, a bacterial endotoxin or a glucan, in a sample. In particular, the invention provides a test cartridge useful in the practice of hemocyte lysate-based assays for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides methods of making and using such cartridges. In addition, the invention provides a rapid, sensitive, multi-step kinetic hemocyte lysate-based assay for the detection and/or quantification of a microbial contaminant in a sample. In addition, the invention provides a glucan-specific lysate that can be used in a variety of assay formats, including, for example, a test cartridge, optionally configured to perform a kinetic assay.

A horseshoe crab Factor C protein having activity of Factor C, wherein the horseshoe crab is selected from Tachypleus tridentatus, Limulus polyphemus, and Carcinoscorpius rotundicauda, and wherein the horseshoe crab Factor C protein is produced through being recombinantly expressed from a Chinese Hamster Ovary (CHO) DG44 cell or HEK cell.

A horseshoe crab Factor C protein having activity of Factor C, wherein the horseshoe crab is selected from Tachypleus tridentatus, Limulus polyphemus, and Carcinoscorpius rotundicauda, and wherein the horseshoe crab Factor C protein is produced through being recombinantly expressed from a Chinese Hamster Ovary (CHO) DG44 cell or HEK cell.

The present invention provides a novel method for the recombinant production of Factor C protein from horseshoe crab using a parasitic protozoan expressing the Factor C protein. In particular, the present invention provides a parasitic protozoan host cell harbouring a polynucleotide encoding horseshoe crab Factor C protein, and a method for producing Factor C protein comprising culturing said parasitic protozoan host cell under conditions such that the cells express the horseshoe crab Factor C protein. Furthermore, the present invention provides recombinant Factor C protein produced by the novel method and its use in the detection and/or removal of endotoxin.

The present invention provides a novel method for the recombinant production of Factor C protein from horseshoe crab using a parasitic protozoan expressing the Factor C protein. In particular, the present invention provides a parasitic protozoan host cell harbouring a polynucleotide encoding horseshoe crab Factor C protein, and a method for producing Factor C protein comprising culturing said parasitic protozoan host cell under conditions such that the cells express the horseshoe crab Factor C protein. Furthermore, the present invention provides recombinant Factor C protein produced by the novel method and its use in the detection and/or removal of endotoxin.

A method for measuring endotoxin in a test specimen, the method, comprising mixing an endotoxin assay agent and the test specimen, and measuring progress of a cascade reaction, wherein the endotoxin assay agent comprises a horseshoe crab Factor C recombinant protein having activity of Factor C and a detection substrate, under the conditions specified.

A method for measuring endotoxin in a test specimen, the method, comprising mixing an endotoxin assay agent and the test specimen, and measuring progress of a cascade reaction, wherein the endotoxin assay agent comprises a horseshoe crab Factor C recombinant protein having activity of Factor C and a detection substrate, under the conditions specified.

Provided are all full-length recombinant proteins involved in the clotting mechanism of Limulus polyphemus, cDNAs encoding the same, and applications thereof. A recombinant protein containing the amino acid sequence represented by SEQ ID NO: 2 or 4, a recombinant protein containing the amino acid sequence represented by SEQ ID NO: 6, 8, 10, or 12, a recombinant protein containing the amino acid sequence represented by SEQ ID NO: 14, 16, 18, 20, or 22, variants thereof, cDNAs encoding the same, and utilization thereof.

Provided are all full-length recombinant proteins involved in the clotting mechanism of Limulus polyphemus, cDNAs encoding the same, and applications thereof. A recombinant protein containing the amino acid sequence represented by SEQ ID NO: 2 or 4, a recombinant protein containing the amino acid sequence represented by SEQ ID NO: 6, 8, 10, or 12, a recombinant protein containing the amino acid sequence represented by SEQ ID NO: 14, 16, 18, 20, or 22, variants thereof, cDNAs encoding the same, and utilization thereof.

A test substrate for detecting a LAL-reactive substance, wherein at least a portion of said test substrate has been preloaded with at least one LAL reagent and/or at least one LAL-reactive standard. Methods of use of the test substrate are disclosed. Methods of depositing test reagents on a test substrate are also disclosed.