Why Test for Interfering Factors Should Be Done

2021-03-11

Why test for interference should be done before endotoxin detection with Lyophilized Amebocyte Lysate reagent (TAL reagent)? The reasons are as follows:


A majority of the substances tested for endotoxin interfere with the TAL test to some degree. Normally, there are two classes of interference: inhibition and enhancement.


If solution containing a material which could interfere with the ability of TAL reagent to react with endotoxin, inhibition will occur. This will lead to the underestimation of the amount of endotoxin present. One of the result is that products which should not be passed are released. And this may harm people’s health. So tests must be properly controlled to ensure that inhibition is detected if it occurs.


Regarding enhancement, it refers to interference that increase the sensitivity of the assay. This will result that endotoxin concentration shown on the result is higher than the actual one. And one of the direct results is that products which should have passed could not be released. But it does not result in a threat to public health and safety.


From this perspective, enhancement is less dangerous than inhibition. This is why in routine gel-clot tests of positive product controls only control for inhibition, but not enhancement. And on the United States, European and Japanese pharmacopeia (USP, EP and JP), the specification in the harmonized endotoxins test chapter allow up to 200% enhancement, but only 50% inhibition.

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