Merck, 1.44154, PyroDetect Kit

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.
Application
The PyroDetect Kit is used for the detection and quantification of the pyrogenic activity in pharmaceutical products to ensure their safety.
Biochem/physiol Actions
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.
Features and Benefits
Ready-to-use kit
Greater product safety
Highly compatible
In vitro test with cryoblood
Reliable results
Regulatory recognition

Other Notes
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

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