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Endotoxin Assay Kits

Endotoxin test is the most critical quality control test required by the FDA for all drugs in their final stages of formulation. Endotoxins are invariably associated with every gram-negative bacteria, so they cause severe reactions in humans and animals and retain high toxic activity even present at low concentration. In addition, endotoxins are suspected to play an important role in the occurrence and development of many different diseases.

GenScript strongly recommends innovative detection technique to detect endotoxin. GenScript’s Endotoxin Assay Kits can be well used in in vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices.

Key Features

  • Good linearity and good reproducibility
  • Ready-to-use reagents and materials, such as tips, endotoxin-free tubes,etc.
  • High sensitivity and board application range
  • Competitive price

Select Your Kit

GenScript ToxinSensorTM Chromogenic LAL Endotoxin Assay Kit and ToxinSensorTM Gel Clot Endotoxin Assay Kit are reliable methods to detect the level of Endotoxins. The procedures in both of these two kits are confirmed with those described in the FDA Guideline.

  • Chromogenic LAL Assay
  • Gel Clot Assay
  • Related Products

ToxinSensorTM Chromogenic LAL Endotoxin Assay Kit: The kit utilizes a modified Limulus Amebocyte Lysate and a synthetic color producing substrate to quantitatively detect endotoxin chromogenically in a broad range (0.005–1 EU/ml).

Note:

  • GenScript has launched a new size (32 rxns) with reasonable price on 03/08/2010.Related components have also been updated!
  • The effectiveness of lyophilization may be greatly affected by limitations of lyophilization technique and other factors such as the size of containers. Therefore, we have changed the original E.coli Endotoxin standard of this kit from 10 EU to 6 EU after 05/12/2010.


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    Ordering Information

    Cat.No. Product Name Size Price Technical Manual Quantitiy
    L00350 ToxinSensorTM Chromogenic LAL Endotoxin Assay Kit 1 Kit
    (32 rxns)
    $ 150
    L00350C ToxinSensorTM Chromogenic LAL Endotoxin Assay Kit 1 Kit
    (16 rxns)
    $ 80

    Technical Advantages:

    Under standard conditions, the absorbance at 545 nm shows a linear relationship with the concentration in range of both 0.005 to 0.1 EU/ml or 0.1 to 1 EU/ml endotoxin. Plot the mean Δabsorbance for the four standards on the y-axis vs the corresponding endotoxin concentration in EU/ml on the x-axis. A best fit line between these points can be used to determine the endotoxin concentrations of samples graphically. See the figure below.

    quantification of endotoxin in cheromogenic assay

    Above is only an example curve show, and the OD values of standards may be different with different assays.
    ToxinSensorTM Gel Clot Endotoxin Assay Kit: It is a qualitative test for Gram-negative bacterial endotoxin. Limulus Amebocyte Lysate as supplied is to be reconstituted with LAL Reagent Water and then mixed in equal parts with the solution being tested. After incubation, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur.

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    Ordering Information

    Cat.No. Product Name Size Price Technical Manual> Quantitiy
    L00351 ToxinSensorTM Gel Clot Endotoxin Assay Kit 1 Kit $ 90

    Technical Advantages:

    Each assay should include both a positive control and a negative control (LAL Reagent Water). Following are application example:
    • Sample: Protein A, 1 mg/ml in PBS, pH 7.4. It is purified from E. coli sonicate by Ni-NTA resin.
    • Dilution by LAL water: 1: 200,000, 1: 400,000, 1: 800,000
    • The test is performed as described above and the assay result is:
    Positive control Negative control 1: 200,000 1: 400,000 1: 800,000
    +
    -
    -
    +
    +
    • Endotoxin concentration in this sample is: from 200,000×0.25 to 400,000×0.25, that is, from 50,000 to 100,000 EU/ml.