Agency
EP Chapter 2.6.30
质量水平
特点
ready-to-use
包装
pkg of 1 kit
制造商/商品名称
PyroDetect
应用
pharmaceutical
pyrogen testing
相容性
configured for PyroDetect Systems
运输
ambient
储存温度
2-8°C
适用性
pyrogenic bacteria
相关类别
一般描述
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.
应用
The PyroDetect Kit is used for the detection and quantification of the pyrogenic activity in pharmaceutical products to ensure their safety.
特点和优势
- Ready-to-use kit
- Greater product safety
- Highly compatible
- In vitro test with cryoblood
- Reliable results
- Regulatory recognition
组分
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
原理
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.
推荐产品
PyroDetect Cryoblood (1.44155)
Reference Standard Endotoxin (1.44161)
NEP Control of HKSA (MATHKSA)
NEP Control of Flagellin (MATFLAGELLIN)
Reference Standard Endotoxin (1.44161)
NEP Control of HKSA (MATHKSA)
NEP Control of Flagellin (MATFLAGELLIN)
控制
警示用语:
Warning
危险分类
Aquatic Chronic 3 - Met. Corr. 1 - Skin Sens. 1
储存分类代码
8A - Combustible, corrosive hazardous materials
WGK
WGK 2
法规信息
新产品
我们的科学家团队拥有各种研究领域经验,包括生命科学、材料科学、化学合成、色谱、分析及许多其他领域.
联系技术服务部门