What test is used for the bacterial endotoxin test (BET) in FDG?

The bacterial endotoxin test (BET) used for FDG, or fluorodeoxyglucose, is the Limulus Amebocyte Lysate (LAL) test. This test is derived from the blood of the horseshoe crab and serves as a highly sensitive assay for detecting endotoxins, which are toxins released from bacteria. The LAL test works by utilizing the unique properties of the lysate; when endotoxins are present, they trigger a coagulation cascade that results in the formation of a gel or a clot.

The significance of the LAL test lies in its critical role in ensuring the safety of pharmaceutical products such as FDG, especially when used in PET imaging. Since these imaging agents are typically injected into patients, it is essential to ascertain that they do not contain harmful levels of endotoxins, which could lead to serious adverse reactions.

Other options provided, while related to quality control and testing in the pharmaceutical industry, do not specifically pertain to the determination of endotoxin levels in FDG. Reverse phase chromatography is generally used for purifying or analyzing small molecules, radiolabeling verification assesses the integrity of the radionuclide labeling, and visual inspection is a qualitative assessment for identifying visible defects or particulates, none