Adapting Your Laboratory Microplate Reader for Bacterial Endotoxin Testing

The Bacterial Endotoxin Test (USP 85) is the standard test for ensuring safety from bacterial endotoxin in pharmaceuticals and medical devices. It involves the use of the Limulus amebocyte lysate (LAL) reagent that produces an increase in turbidity or the onset of color that can be measured by an absorbance reader.

Kinetic analysis is ideal for providing test results with the lowest sensitivity and widest quantitative range. To perform this, however, an absorbance reader with incubation capabilities as well as the ability to perform kinetic analysis is needed.

As this is a test required by the FDA and other regulatory agencies, data compliance and integrity are also required in the electronic records, approvals, and reports of the software used to operate the microplate reader. Protocols that are created by both the test and instrument manufacturers ensure users have reports that fulfill the correct compliance requirements.