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Limulus Amebocyte Lysate (LAL) Assay Kits

Introduction Assay Principle Our Products Contact Us

Introduction

The Limulus Amebocyte Lysate (LAL) assay is the gold standard for detecting bacterial endotoxins. In the pharmaceutical industry, the presence of these pyrogens in parenteral drugs or medical devices can trigger severe physiological reactions, including fever, inflammation, and potentially fatal hypotensive shock. Since its formal adoption, the LAL test has largely replaced the rabbit pyrogen test due to its superior sensitivity, being up to 300 times more effective at identifying minute contaminants. At Creative Biolabs, we provide standardized kits that translate this natural biological response into a high-precision diagnostic tool for modern biomanufacturing.

The innate immunity is stimulated by endotoxins (OA Literature)Fig.1 The innate immunity is stimulated by bacterial endotoxins (LPS).1

LAL Assay Principle

The LAL assay mimics the primitive immune response of the horseshoe crab (Limulus polyphemus). When endotoxins are introduced to the amebocyte lysate, they trigger a sophisticated enzymatic cascade.

Factor C Activation

  • Endotoxin molecules bind to and activate factor C.

Factor B Induction

  • Activated Factor C converts factor B into its active form, which then activates the pro-clotting enzyme.

Signal Generation

  • The pro-clotting enzyme cleaves coagulogen to form a gel, or a colorless substrate to release a measurable yellow pigment.

Our LAL Assay Kits Portfolio

At Creative Biolabs, we provide an extensive selection of testing formats engineered to accommodate diverse sample types, throughput requirements, and sensitivity levels. Our portfolio ranges from traditional qualitative screening to high-precision, automated quantitative analysis.

Gel Clot LAL Kits

This is the standard assay for end-product testing of parenteral drugs and medical devices. It is available in standardized sensitivities to confirm if endotoxin levels are below the required limit.

Rapid Gel Clot LAL Kits

This version is optimized for accelerated turnaround times, making it suitable for in-process monitoring where rapid feedback is required without compromising the integrity of the clot formation.

Micro Gel Clot LAL Kits

Specifically designed for applications where sample volume is highly limited. It utilizes miniaturized reaction volumes to conserve precious materials, such as rare antibodies or small-scale protein batches.

Vacuum Tube Gel Clot LAL Kits

Features pre-measured, lyophilized lysate within a vacuum-sealed environment. This design streamlines direct sampling workflows and significantly reduces the risk of extraneous environmental contamination during the reconstitution process.

Kinetic Chromogenic LAL Kits

This assay measures the release of a yellow color signal as the enzymatic cascade cleaves a synthetic substrate. It is highly sensitive and is the preferred choice for vaccines and biologics that might physically interfere with gel formation.

Kinetic Turbidimetric LAL Kits

This method measures the rate of turbidity increase as the gelation protein precipitates. It provides a sensitive quantitative alternative for samples that have intrinsic color which might interfere with chromogenic readings.

Micro Kinetic Chromogenic LAL Kits

Combines the high sensitivity of chromogenic detection with micro-volume reagent use. This kit is ideal for laboratories processing high volumes of samples who wish to maximize efficiency and minimize cost per test.

Tube Quantitative Chromogenic Matrix LAL Kits

Developed for laboratories that prefer tube-based quantitative workflows for individual sample handling. It is particularly useful for validating complex biotherapeutic drugs where each batch requires precise, individual oversight.

Microplate Quantitative Chromogenic Matrix LAL Kits

Specifically optimized for high-throughput testing of complex matrices (e.g., serum, vaccines, or antivenoms). These kits are pre-configured with specialized buffers to block beta-glucan interference and include dispersing agents to prevent endotoxin from adhering to plastic surfaces.

Contact Us

Creative Biolabs provides the most comprehensive array of LAL Assay Kits designed to meet the rigorous safety demands of the modern biopharmaceutical industry. From traditional Gel Clot formats to high-sensitivity kinetic systems, our products ensure that your parenteral drugs and medical devices are free from pyrogenic contamination and fully compliant with international regulations. Contact us for your projects.

Reference

  1. Harm, Stephan, et al. "An in vitro study on factors affecting endotoxin neutralization in human plasma using the Limulus amebocyte lysate test." Scientific Reports 11.1 (2021): 4192. Distributed under Open Access license CC BY 4.0, without modification. https://doi.org/10.1038/s41598-021-83487-4

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Applications Endotoxin testing
Size 20 T
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Applications Endotoxin testing
Assay Sensitivity 0.01 EU/mL
Detection Range 0.01 - 100 EU/mL
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Applications Endotoxin testing
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Applications Endotoxin testing
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Applications Endotoxin testing
Assay Sensitivity 0.005 EU/mL
Detection Range 0.005 - 50 EU/mL
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Applications Endotoxin testing
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Applications Endotoxin testing
Size 90 T
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Applications Endotoxin testing
Size 80 T
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Applications Endotoxin testing
Size 64 T
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Applications Endotoxin testing
Size 10 sample Kit
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Applications Endotoxin testing
Size One sample Kit
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Applications Endotoxin testing
Size 4500 T
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Applications Endotoxin testing
Size 1600 T
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Size 400 T
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Applications Endotoxin testing
Size 128 T
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