Application

The PyroDetect Kit is used for the detection and quantification of the pyrogenic activity in pharmaceutical products to ensure their safety.

Components

Each PyroDetect Kit contains: Cell Culture Microplate for 96 microcultures, with lid - 1 plate Cell Culture Medium - RPMI with L-Glutamine and HEPES - 50 mL IL-1β Microplate - 12 strips of 8 wells each, coated with a monoclonal antibody specific for IL-1β - 1 plate IL-1β Conjugate Wash Buffer Concentrate Color Reagent α Color Reagent β Stop Solution

Features and Benefits

Ready-to-use kit Greater product safety Highly compatible In vitro test with cryoblood Reliable results Regulatory recognition

General description

PyroDetect Kit is a Monocyte Activation Test (MAT) for the detection of pyrogens. This test allows the determination of the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes.

Principle

The PyroDetect System uses cryopreserved human whole blood as a source of monocytes. The response to pyrogenic substances is determined by measurement of the Interleukin-1β (IL-1β) production. The ELISA (enzyme-linked immunosorbent assay) microplate in the PyroDetect System is precoated with an antibody specific for IL-1β. Interleukin molecules present in the culture supernatant, transferred from the blood cultures, are bound to the immobilized antibody.The unbound substances are washed away, and an enzyme-linked polyclonal antibody specific for IL-1β is added. The IL-1β bound complex is then detected in a color reaction initiated by the addition of a suitable substrate. The efficiency of IL-1β production in the pyrogen reaction is calculated from the data of a photometrical quantification of the colored product by the enzymatic reaction in an ELISA reader.

Recommended products

PyroDetect Cryoblood (1.44155)Reference Standard Endotoxin (1.44161)NEP Control of HKSA (MATHKSA)NEP Control of Flagellin (MATFLAGELLIN)