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Endotoxin and Rapid Microbiological Products
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Endosafe Products and Services: Endosafe-PTS Technical Review The Endosafe® -PTS is a chromogenic LAL test that measures color intensity directly related to the endotoxin concentration in a sample. Each cartridge contains precise amounts of licensed LAL reagent, chromogenic substrate, and control standard endotoxin (CSE). The cartridges are manufactured in a qualified class 1000 GMP manufacturing area according to rigid quality control procedures to ensure test accuracy and product stability. Data Analysis and Acceptance Criteria With the PTS, data reporting is simple. At the conclusion of the test, the endotoxin measurement and the assay acceptance criteria are displayed on the screen. The instrument can be used for endotoxin concentration determinations in the range of 0.01 through 1.0 Endotoxin Units (EU) per mL or 0.05 through 5.0 Endotoxin Units (EU) per mL. Our acceptance criteria for a valid assay is an archived curve correlation coefficient of >[-.980] and positive product control (spike) recovery of 50-200%. |
Data Sheet: Endosafe® -PTS (Portable Test System) Package Insert: Endosafe® -PTS Cartridge User's Guide: Endosafe®-PTS (Portable Test System) What's New
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