A problem to be solved is to perform an immunoassay method for BG in a biological sample having a sensitivity equivalent to and a reactivity similar to a Limulus amebocyte lysate reagent. The problem can be solved by an immunoassay method for β-D-glucan in a biological sample, comprising assaying β-D-glucan in the biological sample by using a monoclonal antibody binding to (1.fwdarw.3)-β-D-glucan having a degree of polymerization of 4.

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 invention relates generally to hybrid amebocyte lysate compositions (including both native and recombinant components) and their use in detecting and/or quantifying endotoxin in a sample.

The invention relates generally to hybrid amebocyte lysate compositions (including both native and recombinant components) and their use in detecting and/or quantifying endotoxin in a sample.

A testing method is described for use in undertaking a test upon a sample (10) for the presence of a specific microbiological material, the method comprising the steps of combining the sample (10) with a viability-preserving medium, optionally with an enrichment medium (12) selected to promote growth and/or reproduction of the specific microbiological material within the sample (10) and incubating the sample (10) and enrichment material (12), undertaking a separation process to separate the live specific microbiological material from the sample (10), and testing the separated material for the presence of the specific microbiological material. An apparatus for use in the method is also described.

A testing method is described for use in undertaking a test upon a sample (10) for the presence of a specific microbiological material, the method comprising the steps of combining the sample (10) with a viability-preserving medium, optionally with an enrichment medium (12) selected to promote growth and/or reproduction of the specific microbiological material within the sample (10) and incubating the sample (10) and enrichment material (12), undertaking a separation process to separate the live specific microbiological material from the sample (10), and testing the separated material for the presence of the specific microbiological material. An apparatus for use in the method is also described.

Provided is a technology related to a horseshoe crab factor B variant, and also provided is means for performing endotoxin measurement with high sensitivity. A polypeptide having an amino acid sequence in which the amino acid residue at the 193-position in an amino acid sequence of a polypeptide of horseshoe crab factor B is substituted with a cysteine (Cys) residue, is produced. Endotoxin measurement can be carried out with high sensitivity by configuring a Limulus reagent by combining this polypeptide with horseshoe crab factor C.

A method for rapidly and highly sensitively measuring endotoxin relies on an endotoxin-measuring agent, which includes a factor C derived from Tachypleus tridentatus that does not have His-tag sequence at the C-terminus, a factor B of a horseshoe crab, and a proclotting enzyme of a horseshoe crab. Each of these proteins can be a recombinant protein obtainable by being expressed using a stably expressing cell line of an insect cell as a host.

A method for rapidly and highly sensitively measuring endotoxin relies on an endotoxin-measuring agent, which includes a factor C derived from Tachypleus tridentatus that does not have His-tag sequence at the C-terminus, a factor B of a horseshoe crab, and a proclotting enzyme of a horseshoe crab. Each of these proteins can be a recombinant protein obtainable by being expressed using a stably expressing cell line of an insect cell as a host.