The test involves two main steps: incubation of the sample in human whole blood and the IL-1ß enzyme-linked immunosorbent assay (ELISA). The sample is mixed with the pooled, freeze-stored cryoblood or fresh blood and incubated. During the incubation, the blood's monocytes produce IL-1ß if the sample contains any pyrogens.

The mixture is transferred to a microplate coated with an antibody that specifically binds IL-1ß. The subsequent ELISA allows the concentration of the bound IL-1ß to be determined. The pyrogen concentration can then be determined using a standard curve.

The assay covers the same full range of pyrogens as the rabbit test and a much broader spectrum than the limulus amebocyte lysate (LAL) test, which detects only endotoxins--lipopolysaccharides--in the outer membrane of gram-negative bacteria.

An addition to Biotest's (Dreieich, Germany) portfolio for laboratories, the PyroDetect system uses human whole blood and therefore can replace all animal pyrogen tests available on the market. It supports a uniquely broad range of applications in medical devices, biologics, pharmaceutics, and cell therapeutics.

Dr. Frank Schulze, executive vice president of microbiology at Biotest AG commented, "There are many products that the existing pyrogen tests cannot reliably test. For example, the rabbit test is unsuitable for cytostatic drugs, sedatives, cytokines, antibiotics, chemotherapeutics, and proteins, the LAL test for blood, lipids, cell therapeutics, and solids. PyroDetect puts an end to these constraints while, at the same time, advancing animal welfare.”

Related Links:
Biotest AG