1.44154

PyroDetect Kit

Reagents and Interleukin-1ß ELISA kit for Monocyte Activation test (MAT), for Pyrogen testing

• 同義詞: Pyrogen testing kit
• 分類程式碼代碼: 41116129
• NACRES: NA.24

屬性

• agency: EP Chapter 2.6.30
• 品質等級: 200
• 特點: ready-to-use
• 包裝: pkg of 1 kit
• 製造商／商標名: PyroDetect
• 應用: pharmaceutical; pyrogen testing
• 相容性: configured for PyroDetect Systems
• 運輸包裝: ambient
• 儲存溫度: 2-8°C
• 適合性: pyrogenic bacteria

描述

一般說明

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.

應用

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

特點和優勢

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

成分

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

原則

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.

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安全資訊

• 象形圖: GHS05,GHS07
• 訊號詞: Warning
• 危險聲明: H290 - H317 - H412
• 防範說明: P234 - P261 - P272 - P273 - P280 - P302 + P352
• 危險分類: Aquatic Chronic 3 - Met. Corr. 1 - Skin Sens. 1
• 儲存類別代碼: 8A - Combustible, corrosive hazardous materials
• 水污染物質分類（WGK）: WGK 2