The present invention is related to compositions comprising clarified limulus amebocyte lysate (LAL), wherein the LAL is substantially free of coagulogen and methods of making such compositions. The invention further relates to a method of detecting an endotoxin in a sample using a chromogenic assay, the method comprising: (a) contacting the sample with a reagent comprising clarified LAL and a chromogenic substrate; and (b) measuring a chromogenic effect resulting from a change in the chromogenic substrate in the presence of endotoxin in the sample, wherein the LAL is substantially free of coagulogen. The invention also relates to kits comprising clarified LAL substantially free of coagulogen, and methods of making such.

The present invention provides a combination containing (1) a composition containing a live bacterium of Bacteroides vulgatus isolated from nature, and (2) a composition containing a live bacterium of Bacteroides dorei isolated from nature.

Provided herein are methods and compositions for overcoming Low Endotoxin Recovery (LER) and unmasking endotoxins. The compositions and methods provided herein may be used to prepare samples such as drug products for endotoxin testing.

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 and described herein is the use of an oligomeric protein as a binding agent for binding to lipopolysaccharide (LPS), the oligomeric protein having a coiled coil structure comprising at least two monomer peptides, wherein each monomer peptide, which may be the same or different, is capable of forming an α-helix and comprises at least one core sequence having at least 60% sequence identity to the heptad repeat sequence of SEQ ID NO. 1. Also provide and described herein are methods of binding, detecting and removing LPS, and products comprising the oligomeric protein.

A method of detecting an endotoxin of detecting an endotoxin from a test subject sample using a fluorescent substance having a structure in which a fluorescent site and a recognition site are connected by a spacer, wherein the recognition site recognizes a specific site of a molecular structure of an endotoxin.

A water quality testing method, operable to detect the presence or level of faecal contamination of water, is described comprising the steps of placing a water sample (10) within a reaction chamber (12) containing a reagent, the reagent being in, for example, tablet form, or placing the water sample (10) within a single use reaction chamber (12) pre-packaged with a single dose of the reagent, incubating the sample (10) at a predetermined temperature for a predetermined period of time to form a reaction solution (10a), and using the colour or darkness of the solution (10a) to provide an indication of the water quality.

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.

The present disclosure relates to a method of analyzing a biofluid of a subject for the presence of bacterial extracellular vesicles (EV), the method comprising the steps of a) extracting bacterial EV from the biofluid, b) analyzing the bacterial EV-extracted molecular patterns for the presence of a disease marker, wherein the disease marker is a disease-specific molecular pattern of the subject; and the subject comprising patients diagnosed with HIV, IBD or cancer or the subject receiving a treatment.