GXP

Variability and the LAL Assay for Bacterial Endotoxin Detection

With biological tests all measurements susceptible to variations in analytical conditions should be suitably controlled as far as is practicable. Here the LAL assay has a relatively elevated level of variability even for a biological assay (4). This variation derives from three principle sources: reagents, product, and method / instrumentation (5). This article examines some of the reasons for this variation in relation to the test and the test reagents. The article also examines the coefficient of variation which is one way to examine for test variation. Coefficient of variation is measure of...

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