αBET test system from CMD – New Possibilities

Gram-negative bacteria contain a group of lipopolysaccharides (LPS) known as bacterial endotoxins. Endotoxins, which are an integral part of the bacteria’s outer membrane, play a crucial role in regulating cell viability, particularly in processes like nutrient uptake. Additionally, they serve as a vital defence mechanism, safeguarding the cell against potential threats present in its environment. However, symptoms such as high fever, vomiting, and diarrhoea can be triggered by these endotoxins if they come in contact with human body.^[1]

Mode of transmission

Endotoxins can be spread through various means, including water, medical equipment, injectable drugs, and other medicines. To prevent infection, it is crucial to regularly check for contamination. The FDA has granted approval to a range of tests, such as the LAL reagent and Monocyte Activation Type (MAT) Pyrogen Test, to assess contamination levels.^[2]

LAL Assay Pyrogen test

In order to achieve a higher level of specificity in detecting endotoxins, the Rabbit Pyrogen Test (RPT) method has mostly been substituted with assays that utilize Limulus Amoebocyte Lysate (LAL).^[1]

CMD αBET™ system

FUJIFILM and Cotton Mouton Diagnostics Ltd (CMD) have worked together to create a comprehensive testing system that integrates seamlessly, offering a faster and more environmentally friendly solution for endotoxin testing. This system maintains high sensitivity and performance levels, ensuring accurate results.

Functioning of CMD αBET™ system

The accuracy and precision of the aBET™ system are comparable to those of existing tube reader-based LAL assays, indicating substantial equivalence in performance.

Through the strategic use of a small amount of the FDA-licensed turbidimetric Limulus amoebocyte lysate (LAL) reagent, this testing method stands out for its ability to produce quantitative results in less than half the typical time taken by other formats, and with little need for the user to be extensively involved.

Advantages of CMD αBET™ system

FDA Compliant software: Our FDA-licensed LAL reagent offers quicker results with minimal user input. Users are guided through a pharmacopeial compliant assay by the on-board software, which is FDA part 11 ready and prioritizes the preservation of data integrity.^[3].

Device features: The device features a 7-inch touchscreen that is responsive and easy to navigate. The package includes access cards, each with a QR code. There is one card for the administrator and ten for users.

Portability and speed: The device is easily transportable and yields precise results in a relatively short period of time. The device utilizes a consumable with four channels, allowing for four concurrent tests. The run times range from approximately 3 minutes for a 10 EU/mL sample to around 30 minutes for samples containing 0.001 EU/mL.

Cost saver: This technique is financially efficient due to its minimal reagent requirement. Demonstrating superior performance by utilizing less than 10% of the turbidimetric LAL reagent.

User friendly: Only a minimal amount of user input is required, aside from adding a sample. Step-by-step instructions for conducting various assays are provided.

Advanced Features: This product is designed to work with both colorful and opaque samples. The PYROSTAR™ ES-F 0.015EU/mL reagent comes in single test, 20 test, and 50 test vials, providing with flexibility in usage.

The CMD αBET™ system is FDA compliant, and also provides a user-friendly & portable solution. Moreover, it provides a quicker option compared to conventional pyrogen testing techniques. The LAL reagent, known for its exceptional efficacy in pyrogen testing, is employed to conduct the tests.

References

1. Bech Ørving, R., et al., Bacterial Endotoxin Testing-Fast Endotoxin Masking Kinetics in the Presence of Lauryldimethylamine Oxide. Microorganisms, 2020. 8(11).
2. Sattar, A.A., et al., Endotoxin as a Marker for Water Quality. Int J Environ Res Public Health, 2022. 19(24).
3. Jagadeeswaran, I., N. Palani, and G. Lakshmanan, FDA-CFR Title 21-Food and Drugs: Parts 800 to 1299, in Medical Device Guidelines and Regulations Handbook. 2022, Springer. p. 189-236.