1.44154
PyroDetect Kit
Reagents and Interleukin-1ß ELISA kit for Monocyte Activation test (MAT), for Pyrogen testing
Synonym(s):
Pyrogen testing kit
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About This Item
UNSPSC Code:
41116129
NACRES:
NA.24
Recommended Products
agency
EP Chapter 2.6.30
Quality Level
feature
ready-to-use
packaging
pkg of 1 kit
manufacturer/tradename
PyroDetect
application(s)
pharmaceutical
pyrogen testing
compatibility
configured for PyroDetect Systems
shipped in
ambient
storage temp.
2-8°C
suitability
pyrogenic bacteria
Related Categories
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.
Features and Benefits
- Ready-to-use kit
- Greater product safety
- Highly compatible
- In vitro test with cryoblood
- Reliable results
- Regulatory recognition
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
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.
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.
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Control
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Description
Pricing
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Warning
hcodes
Hazard Classifications
Aquatic Chronic 3 - Met. Corr. 1 - Skin Sens. 1
Storage Class
8A - Combustible, corrosive hazardous materials
wgk_germany
WGK 2
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