Endotoxin is a glycocalyx attached to the outer leaflet of the outer membrane of gram-negative bacteria and is an important component of the outer membrane, consisting of lipid A, core oligosaccharides, and O-antigenic polysaccharides. Lipid A is the active and toxic center of endotoxin. Endotoxin is a toxic compound that can cause fever, microcirculatory disorders, endotoxic shock, and disseminated intravascular coagulation. Endotoxins are thermally stable, widely present in the environment, and easily contaminate biological products. Therefore, endotoxin assay is necessary for the biological and pharmaceutical industries. Creative Diagnostics provides accurate endotoxin ELISA testing for all manufacturing stages of biologics.

Testing Capabilities

We detect endotoxins released by the rupture of a wide range of gram-negative bacteria, including but not limited to E. coli, Salmonella, S. typhi, S. dysenteriae, etc.

Species Reactivity

ELISA Assay Types

In endotoxin ELISA testing services, we usually use:

• Direct ELISA
• Indirect ELISA
• Competitive ELISA
• Cell-based ELISA

ELISA Assay Options

• Qualitative Assay
• Quantitative Assay
• Semi-quantitative Assay

Sample Types

The endotoxin is highly stable and for sending the sample you have the following options.

1. Send the sample to be tested directly under frozen condition.

2. Send the sample after simple processing.

3. Send the endotoxin after extraction.

Customer to Provide

• Detailed information about the endotoxin to be tested, source, etc.
• Detailed information about the sample to be tested. Biological products can be labeled with the purpose, strains can be labeled with species information, purpose of the test, etc.
• Sample(s) to be tested. Please use an adequate amount of dry ice to transport the sample.
• Negative controls and sufficient primary antibodies meeting the criteria.
• ELISA kit. There are 4 main sources of ELISA kits used in the testing service: 1. purchase our ELISA kits. 2. provided by you. 3. purchased by our company. 4. choose our customized ELISA kits service.

Delivery Content

• Raw OD values
• Data analysis results
• Pre- and post-termination photos

Service Content

• You are responsible for any problems caused by incorrect samples or incomplete information provided by you.

Service Advantages

• The detection period is short. Routine test results usually only take 1-2 days.
• Professional testing team. Each testing service has professional technicians to formulate experimental plans.
• A wide variety of samples can be detected. We can detect endotoxin levels in various biological products such as DNA, recombinant proteins and antibodies, vaccines, etc.
• Strict quality control. During endotoxin testing, we perform quality control in compliance with European and US Pharmacopoeia and US Food and Drug Administration.

Creative Diagnostics provides you with endotoxin testing services to help your biologics comply with the essential requirements of Good Manufacturing Practice (cGMP) and other quality control regulations. At the same time, it also provides corresponding ELISA customization services and development services. If you are interested in our endotoxin ELISA testing services, please contact us directly.