Endotoxin Detection & Removal System
Endotoxin is a major contaminant found in biologically active substances. The presence of endotoxin can cause pyrogenic reactions in host organisms such as endotoxin shock, tissue injury, and even death. Endotoxin detection test is one of the most critical quality control tests required by the FDA for all drugs in their final formulation. Therefore, it is essential to remove endotoxin from human and animal parenteral drugs, biological products, and medical devices.
ToxinSensor™ Endotoxin Detection System uses FDA approved LAL (Limulus Amebocyte Lysate) testing methods to achieve a fast and highly sensitive endotoxin assay. The Chromogenic LAL Endotoxin Assay kit can quantitatively detect endotoxin in a broad range (0.005–1 EU/ml). The Gel Clot Endotoxin Assay kit is a fast qualitative test showing a positive or negative result. ToxinEraser™ Endotoxin Removal System facilitates the endotoxin removal process with a high binding capacity (> 2,000,000 EU/ml).
- Delivered with ready-to-use reagents and materials
- Strong linearity and reproducibility
- Guaranteed high-sensitivity: 0.005 EU/ml
ToxinSensor™ Endotoxin Assay Kits can be widely used in in vitro end-product endotoxin tests, including those for human and animal parenteral drugs, biological products, and medical devices.
- High binding capacity at least 2, 000, 000 EU / ml (CV)
- High Recovery Yield: >90% with minimized sample loss
- High stability and high removal efficiency: Bring down endotoxin level to as low as 0.1 EU/ml*.
* With repeat use of ToxinEraser™ endotoxin removal resin. Final removal efficiency may vary depending on the sample type/source.
GenScript ToxinEraser™ is an efficient endototoxin removal tool. The final endotoxin level can be reduced below 1 EU/mg with repeated use of ToxinEraser™ Advanced Endotoxin Removal resin. These kits can be used to remove endotoxin from proteins, peptides, antibodies, or even DNA samples.
|ToxinSensor™ Chromogenic LAL Endotoxin Assay Kit||ToxinSensor™ Gel Clot Endotoxin Assay Kit||ToxinSensor™ Single Test Kit|
|General Introduction||This kit utilizes chromogenic LAL assay to quantitatively detect endotoxin in a broad range.||This kit is a convenient endotoxin qualitative test based on gelation principle.||This kit is a one-step qualitative endotoxin test; various sensitivities are available.|
|Application||Accurately determine endotoxin levels||End-product endotoxin qualitative detection||One-step end-product endotoxin qualitative detection|
|Sensitivity||0.005–1 EU/ml||0.25 EU/ml||0.015 EU/ml- 0.25 EU/ml|
|Reconstitute LAL with LAL Reagent Water|
|Sample Requirement||Colorless and Clear liquid||N/A||N/A|
|Size||L00350C 16 rxns
L00350 32 rxns
|L00351 40 assays||L00447 - L00451
20/ 40 assays
How to run an endotoxin detection assay for medical devices?
Infuse 15 ml of endotoxin-free water into the lumen of medical device (e.g. infusion apparatus, dialysis tubing, etc.) and shocks five times, seal all the ends and incubate it at 37°C water bath for 2 hours, then transfer the water to an endotoxin-free vial. Detect the endotoxin concentration in the water by using ToxinSensor™ Chromogenic LAL Endotoxin Assay Kit (Cat. No. L00350), and the total endotoxin value in the water can be determined.
Can I use plastic ware when I prepare standard endotoxin solution?
Endotoxins adhere strongly to glassware and are difficult to remove completely during washing. Standard laboratory autoclaving procedures have little or no effect on endotoxin levels. Heating glassware at 180°C overnight is recommended to destroy any attached endotoxin molecules. We recommend you to only use new plastic ware tubes which are certified to be endotoxin-free when you prepare standard endotoxin solution. GenScript supplies ToxinSensor™ Endotoxin-free Tubes (Cat. No. M01072) for you to dilute or aliquot samples. Endotoxin adheres to plastic surfaces more strongly than glass surfaces.
Is standard endotoxin solution reusable after developed (color formed)?
No. Standard endotoxin solution should be prepared fresh for each test.
How to determine the reliability of the final data?
Firstly, we recommend you to prepare all materials included in the kit in a laminar flow cabinet and avoid contamination during assay process.
For ToxinSensor™ Chromogenic LAL Endotoxin Assay Kit (Cat. No. L00350), if the OD value of your sample is in the range of the standards, the final data will be reliable after you obtain a good linearity (R≥0.980).
For ToxinSensor™ Gel Clot Endotoxin Assay Kit (Cat. No.L00351), you can obtain the reliable final result through negative and positive controls. If you get a positive result in the negative control, it may indicate that the LAL or LAL reagent water has been contaminated, or if you get a negative result in the positive control, it may indicate that the LAL reagent has lost activity.
Can I use 96-well microplate to read the absorbance of each reaction at 545 nm?
ToxinSensor™ Chromogenic LAL Endotoxin Assay Kit (Cat. No. L00350) is designed to deliver high sensitivity quantitative assay in tubes, and not intended to be used for a 96-well plate assay. However, you can perform the assay in tubes, after color development, transfer 200 µl of the final solution into an endotoxin-free 96-well plate to read the result.
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