Biotest has launched the Pyrodetect system for the robust testing of a range of pyrogens, for laboratories in the pharmaceutical, medical-device, cosmetics and food industries.
Pyrodetect, a patented assay for detecting and quantifying diverse exogenous pyrogens, is based on the Monocyte-Activation Test (MAT) with an Interleukin-1B (IL-1B) response.
As it uses human whole blood, it is said to simulate human pyrogen-induced fever reactions better than any animal test available on the market.
An international validation study coordinated by the European Centre for the Validation of Alternative Methods (ECVAM) found the MAT to be a reliable test system.
As a consequence it was introduced into the European Pharmacopoeia (EP Chapter 2.6.30) in 2010 as an alternative to the rabbit test.
Pyrodetect covers the same full range of pyrogens as the rabbit test and a broader spectrum than the Limulus Amebocyte Lysate (LAL) test, which detects endotoxins.
In addition to endotoxins, Pyrodetect detects pyrogenic substances from gram-positive bacteria, as well as pyrogenic particles from moulds and yeasts, viruses and environmental contaminants such as packaging material.
It supports a range of applications in pharmaceuticals, biologicals, medical devices and cell therapeutics.
Using Pyrodetect involves two main steps: incubating the sample in human whole blood and performing the IL-1B ELISA.
First the test sample is mixed with the pooled, freeze-stored cryoblood, or fresh blood, and incubated, during which the blood's monocytes produce IL-1B if the sample contains any pyrogens.
For detection, the mixture is transferred to a microplate coated with an antibody that specifically binds IL-1B.
The subsequent ELISA allows the concentration of the bound IL-1B to be determined.
The pyrogen concentration can then be determined using a standard curve.
Pyrodetect is a humane, full-fledged substitute for the rabbit test and is suited to complement the LAL test for testing newly approved research products.
