A process of using a fish plasma component in a nutrient medium for cell culture includes obtaining a fish that is a progeny of domesticated broodstock that are reared under consistent and reproducible conditions. Blood is obtained from the fish, and plasma is separated from the blood. One or more specific components of the plasma are then extracted, and cells are cultured in a nutrient medium using the one or more extracted plasma components, and none of any remainder of the plasma. The plasma and/or the plasma components is/are tested for presence and/or level of endotoxin. Extracting the one or more specific components of the plasma, and/or culturing the cells is only performed if the testing indicates an endotoxin level below a predetermined threshold. The cells cultured using the extracted one or more plasma components are other than fish cells.

A process of using a fish plasma component in a nutrient medium for cell culture includes obtaining a fish that is a progeny of domesticated broodstock that are reared under consistent and reproducible conditions. Blood is obtained from the fish, and plasma is separated from the blood. One or more specific components of the plasma are then extracted, and cells are cultured in a nutrient medium using the one or more extracted plasma components, and none of any remainder of the plasma. The plasma and/or the plasma components is/are tested for presence and/or level of endotoxin. Extracting the one or more specific components of the plasma, and/or culturing the cells is only performed if the testing indicates an endotoxin level below a predetermined threshold. The cells cultured using the extracted one or more plasma components are other than fish cells.

A method of determining the result of an assay in a microfluidic device includes the steps of: dispensing a sample droplet onto a first portion of an electrode array of the microfluidic device; dispensing a reagent droplet onto a second portion of the electrode array of the microfluidic device; controlling actuation voltages applied to the electrode array to mix the sample droplet and the reagent droplet into a product droplet; sensing a dynamic property of the product droplet; and determining an assay of the sample droplet based on the sensed dynamic property. The dynamic property is a physical property of the product droplet that influences a transport property of the product droplet on the electrode array. Example dynamic properties of the product droplet include the moveable state, split-able state, and viscosity based on droplet properties. The method may be used to perform an amoebocyte lysate (LAL) assay.

A method of determining the result of an assay in a microfluidic device includes the steps of: dispensing a sample droplet onto a first portion of an electrode array of the microfluidic device; dispensing a reagent droplet onto a second portion of the electrode array of the microfluidic device; controlling actuation voltages applied to the electrode array to mix the sample droplet and the reagent droplet into a product droplet; sensing a dynamic property of the product droplet; and determining an assay of the sample droplet based on the sensed dynamic property. The dynamic property is a physical property of the product droplet that influences a transport property of the product droplet on the electrode array. Example dynamic properties of the product droplet include the moveable state, split-able state, and viscosity based on droplet properties. The method may be used to perform an amoebocyte lysate (LAL) assay.

A system for processing a sample includes a unitary body. The unitary body including a snap lid, the snap lid having a capillary. The unitary body including a lysing container. The unitary body including a test element and a sliding actuator.

A system for processing a sample includes a unitary body. The unitary body including a snap lid, the snap lid having a capillary. The unitary body including a lysing container. The unitary body including a test element and a sliding actuator.

It is necessary to establish a purification method effective for the removal of endotoxin, in order to obtain thermolysin containing a reduced amount of contaminant endotoxin. On the premise of the establishment, accurate measurement of the amount of endotoxin that contaminates thermolysin is required. The present invention addresses the problem of providing a novel measurement method which enables accurate measurement of the amount of endotoxin that contaminates thermolysin. The present invention also addresses the problem of providing thermolysin containing a reduced amount of contaminant thermolysin, and the use thereof. There is provided thermolysin containing contaminant endotoxin in an amount of 1 EU/mg or less. There is also provided a method for measuring endotoxin that contaminates thermolysin, the method including pretreatment of deactivating the thermolysin. An enzyme preparation including the thermolysin according to the present invention as an active ingredient has a high utility value in the field of regenerative medicine.

It is necessary to establish a purification method effective for the removal of endotoxin, in order to obtain thermolysin containing a reduced amount of contaminant endotoxin. On the premise of the establishment, accurate measurement of the amount of endotoxin that contaminates thermolysin is required. The present invention addresses the problem of providing a novel measurement method which enables accurate measurement of the amount of endotoxin that contaminates thermolysin. The present invention also addresses the problem of providing thermolysin containing a reduced amount of contaminant thermolysin, and the use thereof. There is provided thermolysin containing contaminant endotoxin in an amount of 1 EU/mg or less. There is also provided a method for measuring endotoxin that contaminates thermolysin, the method including pretreatment of deactivating the thermolysin. An enzyme preparation including the thermolysin according to the present invention as an active ingredient has a high utility value in the field of regenerative medicine.

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 point-of-use kit is designed for optically detecting and quantifying bacterial endotoxin by employing specific formulations of Limulus amebocyte lysate (LAL), each formulation designed to optimize results with different sample classes. Kits are pre-certified for use with a variety of environmental, industrial, and clinical samples, each sample category having a unique kit design and containing a unique lysate reagent formulation. Pre-certification transfers time and reagent consuming tasks, such as assessment of sample compatibility and sample effect on reagent sensitivity to endotoxin from the user to the kit producer. A fixed dilution/sample treatment is employed, eliminating the need for a comparative water standard and for a sample positive control. The kit has LAL reagent prepackaged in dry polyethylene capped tubes, which retains reagent shelf life and optical clarity for accurate and reproducible results using a portable spectrophotometer/optical reader.