Endotoxins are strong pyrogens, which, if they gain access to the bloodstream, can cause severe fever, inflammation, and even septic shock. To minimize the risk of endotoxin contamination, endotoxin testing is implemented routinely in the pharmaceutical industry for drugs and medical devices that may come in contact with the cardiovascular or lymphatic system, cerebrospinal fluid, or intraocular environment.
The Limulus amoebocyte lysate (LAL) assay is the most widely used endotoxin test. However, the classical gel clot LAL assay is qualitative and, despite its high sensitivity and specificity, does not allow endotoxin quantification. Therefore, quantitative LAL assays, based on turbidimetric or chromogenic analysis, have been developed. In addition, manufacturers have focused their efforts on the design and production of reliable and efficient systems for quantitative endotoxin determination.
The CMD αBET™ system was developed as a fully integrated system for endotoxin testing that is based on the pharmacopeial-compliant and FDA-licensed turbidimetric LAL reagent. It maintains the sensitivity, specificity, and reliability of the classical gel clot LAL assay, but also provides rapid quantitative results, runs four tests simultaneously, and minimizes user input and reagent consumption. Among other reagents, the CMD αBET™ system can be used with the PYROSTAR™ ES-F 0.015EU/mL reagent, which is available in single test, 20 test, and 50 test vials. The CMD αBET™ system has found applications in the pharmaceutical industry for in-process and final-product testing and quality control.
Portability and full integration– The CMD αBET™ bench top system is fully integrated with FDA 21 CFR Part 11 compliant software. It enables data back up to PC by binary code and in two formats (native firmware and HTML). The system also includes a 7-inch touchscreen and QR code access cards.
High sensitivity with a detection limit of 0.001EU/mL. Similar to other turbidimetric assays, the CMD αBET™ system detects light transmission changes through a sample to evaluate a reaction’s progress. However, it also uses a proprietary magneto-optical sensor technology with polarizing optics to achieve enhanced sensitivity. Using this innovative technology, CMD αBET™ measures changes in the amplitude of induced light modulation during a turbidimetric reaction with higher sensitivity than conventional turbidimetric readers in a tube, plate, or cartridge format.
Accuracy and reliability, which are similar to those of other LAL assays performed using tube readers.
Versatility – The CMD αBET™ system is compatible with numerous complex biological, pharmaceutical, and nanosamples. It is less impacted by sample haziness or color than other chromogenic and turbidimetric assays and can be used for the analysis of opaque and colored samples.
Ease of use with guided steps for the performance of a variety of assays and minimal required input from users apart from sample addition.
Prompt delivery of results with run times ranging between 3 minutes (for 10 EU/mL samples) and 30 minutes (for 0.001 EU/mL samples).
Cost savings, as the system requires smaller reagent volumes than traditional assays.