Comparing Endotoxin Detection Methods

The higher the CV% value is, the more variation there is between the two test replicates, meaning a lower level of precision for the result. Because it is user friendly, the chromogenic method has become the "go to" method for many testing labs, but the sensitivity of the test means that i...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2017-11, Vol.29 (11), p.44-47
Main Author: Wheeler, Alex
Format: Article
Language:English
Subjects:
Automation
Bacteria
Gram-negative bacteria
Manufacturing
Medical device industry
Medical equipment
Methods
Patient safety
Pharmaceuticals
Raw materials
Sepsis
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Summary:The higher the CV% value is, the more variation there is between the two test replicates, meaning a lower level of precision for the result. Because it is user friendly, the chromogenic method has become the "go to" method for many testing labs, but the sensitivity of the test means that interference can be an issue. The reaction time (i.e., the amount of time required for the mixture to reach onset OD) is inversely proportional to the amount of endotoxin present. [...]by spiking the sample with known quantities of endotoxin in sterile water and creating a standard curve, the quantity of endotoxin present in the mixture can be calculated. Yet another consideration is the potential for technician error in interpreting test results. [...]the endotoxin testing process can be fully automated, with minimal human interference, subjectivity may affect the interpretation of results. [...]it is a time-consuming process. Because it is user friendly, the chromogenic method has become the "go to" method for many testing labs, but its sensitivity means that interference can be an issue. [...]the endotoxin testing process can be fully automated, with minimal human interference, subjectivity may affect the interpretation of results.
ISSN:1753-7967