Endotoxin Test Assay by Lyophilized Amebocyte Lysate (LAL Reagent)

Endotoxin Test Assay by Lyophilized Amebocyte Lysate (LAL Reagent)

LAL Reagents: Lyophilized amebocyte lysate (LAL) is an aqueous extract of blood cells (amebocytes) from the Atlantic horseshoe crab.
TAL Reagents: TAL reagent is an aqueous extract of blood cells from Tachypleus tridentatus.
At present, the main production of LAL/TAL reagents are in the United States and China.

Gel clot endotoxin test assay, this method still is the main applications in all over the world, in order to meet the safety requirement of the Human injection medicines.
CURRENTLY Bioendo produces and supplies gel clot LAL reagent including to the single test glass ampules and multi test vials.
https://www.bioendo.com/gel-clot-endotoxin-assay/ G01, GS44, G02, G17 and G52
This is the economical solution for qualitative endotoxins detection in the drug test. Especially for the injectable drugs or parenteral drugs to test endotoxins in WFI, API or finished drug products. Endotoxin test assay is a high demand of operation actions, need proficient operator to deal with the gel clot assay to ensure the correct reuslts.

A complete solution for G52 Endotoxin test assay:
LAL Reagent
Control Standard Endotoxin
BET Water
Endotoxin-free pipette tips
Endotoxin-free glass tubes, including dilution operation and reaction tubes.
Incubation instrument, to recommend the water bath or dry heat incubator. All incubation devices require temperature precision.
All consumables to touch the LAL assay which meets the standard of endotoxin-free level ” < 0.005EU/ml ” .
Experimental environment shall be suit to the endotoxin detection.

Pay attention to :
Plastic consumables like pipette tips or multiwell plates are widely used for endotoxin testing. The harmonized Pharmacopoeias (USP/CP) require that any plastic consumables and glass tubes have to be free of detectable endotoxin and equally important but often not considered, they must the standard of free of interfering factors.

How to operate the endotoxin test assay to detect the endotoxins in the sample?
First of all, the test for confirmation of labeled lysate sensitivity should be carried out. To confirm the sensitivity is the same to the label marks.
For sample analysis, conduct pre-interference endotoxin test assays.
To operate the complete endotoxin assay of “ interference test ”.
To operate the limit test for the getting how is the endotoxins level in the sample.

When operation the test for confirmation of labeled lysate sensitivity, the result is abnormal, 2 Lamada havenot gel formation?
Check whether the preparation method of the bacterial control standard endotoxin is correct.
Vortex mixing is required for each diluent (see the instruction manual or called insert of the control standard endotoxin in details).
To check whether the lysate reagent matches the control standard endotoxin.

It is recommended to use a water bath or a dry heat incubator for the constant temperature process of the lysate reagent (for example, an incubator or a dry box is not effective).
During the incubation, water environment in the water bath that is static and stable, all vibrations are avoided.
Pay special attention to the water bath to turn off the water flow pump.

Judging the result, gently take out the test tube or glass ampoule from the thermostat, slowly invert 180 degrees,
the gel formation in the tube will not be deformed, and will not slip off, the result was recorded by signal “+”;
no gel formation is formed or the gel clot can not be kept intact even though it is formed.
The wall slip is negative, the result was recorded by signal “-”.
Rapid gel clot endotoxin test Kit belongs to the gel clot endotoxin test method.
In the rapid gel clot endotoxin testing, the sample positive control does not generate gel?
First, use bacterial endotoxin test water to verify the lysate reagents, ensure the operators and the environment have meet the regulations;

If the kit is qualified, then the positive control of the sample does not gel formation due to the inhibitory effect of the sample, and the sample should be processed and be treated.
The most common sample processing method is dilution.