MICROBIOLOGICAL TESTING

Endotoxin Test

Bacterial Endotoxin Test (BET), also known as the Limulus Amebocyte Lysate (LAL) test is an in-vitro assay for the detection and quantitation of bacterial endotoxins. Bacterial endotoxin is a pyrogenic component found in the cell wall of gram-negative bacteria. Pyrogenic substance can induce fever when injected into the blood or cerebrospinal fluid. Hence, it is always important to test for endotoxin contamination especially for humans and animals parenteral drugs, biological products and medical devices.

Cytonex provides endotoxin testing using the gel clot method. Detection level of the endotoxin can be up to 0.06 EU/ml.

Mycoplasma Test

Mycoplasma, the smallest and simplest self-replicating prokaryotic organism, that frequently contaminate cell cultures. Due to their small size, they can pass through filters and remain invisible to the naked eye and undetectable by light microscopy. However, contamination of cell culture by mycoplasmas can have disastrous effects on eukaryotic cells as they can modify many aspects of cellular functions such as proliferation, protein synthesis, etc. Hence, mycoplasma testing is an essential quality control requirement to ensure the biotechnology products produced are safe and reliable.

Cytonex provides mycoplasma testing using the PCR method, which provides results within a few hours. The assay used allows detection of various mycoplasma species, which includes M. fermentans, M. hyorhinis, M. arginini, M. orale, M. salivarium, M. hominis, M. pulmonis, M. arthritidis, M. bovis, M. pneumoniae, M. pirum and M. capricolum, as well as Acholeplasma and Spiroplasma species, with high sensitivity and specificity.