Kinetic Chromogenic LAL/TAL Endotoxin Test Kit — Quantitative Bacterial Endotoxin Testing

The gel-clot method tells you whether endotoxin is present. The kinetic chromogenic method tells you exactly how much — and does it across 96 wells at once, with a standard curve, automated calculation, and an objective absorbance readout that eliminates the subjectivity of visual gel interpretation.

The FireGene Kinetic Chromogenic Endotoxin Test Kit uses the TAL (Tachypleus Amebocyte Lysate) enzymatic cascade: bacterial endotoxin activates Factor C → Factor B → procoagulase → coagulase, which hydrolyzes the chromogenic substrate to release free pNA (p-Nitroaniline). The resulting yellow color is monitored kinetically at 405 nm. The time to reach a defined absorbance threshold is inversely proportional to endotoxin concentration, enabling precise EU/mL quantification from a standard curve.

Everything included. No separate reagent sourcing required.

Instrument compatibility

Works with any microplate reader capable of absorbance measurement at 405 nm (340–750 nm range). No dedicated endotoxin reader required — compatible with standard lab microplate readers including BioTek, Molecular Devices, BMG Labtech, and equivalent instruments.

When to choose kinetic chromogenic over gel-clot

• You need quantitative EU/mL values, not just a positive/negative result
• You are running multiple samples per batch and need throughput
• Your QC process requires data trending and audit-trail documentation
• Your sample matrix contains inhibitors that interfere with turbidimetric methods
• You are validating a method under USP <85>, EP 2.6.14, or JP 4.01 with a standard curve requirement

Applications

• Release testing of parenteral drugs and biologics
• Medical device extract endotoxin quantification
• Water for injection (WFI) and process water monitoring
• Raw material and excipient screening
• Dialysis consumable quality control
• CRO/CDMO endotoxin testing services
• R&D process development and optimization

Composition:

• Name	Component	Qty.	Spec.
  R1 main reagent	It contains protein complexes, such as C factor, B factor and proclotting enzyme, as well as chromogenic substrate	4 vials	2.6mL
  R2 standard	It contains lipopolysaccharide lyophilized powder; potency calibrated against national standard product	6 vials	See volume on label
  R3 water	Pyrogen-free water	3 vials	8mL
  R4 reconstitution solution	Tris-HCl buffer solution	4 vials	3mL
  R5 microplate	----	1 plate	96 wells

Mechanism:

Bacterial endotoxin can specifically activate factor C in Limulus reagent, activated factor C activates factor B, activated factor B then activates procoagulase, coagulase hydrolyzes the chromogenic substrate in the reaction, and produces free pNA ( P-Nitroaniline) to cause absorbance changes, and the endotoxin concentration is quantified based on the kinetic detection solution absorbance change rate.

Specifications

Methodology	Kinetic Chromogenic Method
Time to Report	~ 90 minutes
Used For	Injection drugs, Biological products, and Medical devices
Storage and Expiry	At 2-8°C the product can be stored for 24 months before opening.
Equipment & Consumables	Microplate reader, vortex shaker, pipette, Endotoxin-free tip are available to purchase. Tecan microplate reader is recommended.

 

Product Q&A

Q: What is the shelf life of the kinetic chromogenic endotoxin testing kit? 

A: The shelf life of the kinetic chromogenic endotoxin testing kit is 2 years from the date of manufacture under recommended storage conditions.

Q: What instruments will be needed for the kinetic chromogenic endotoxin testing kit? 

A: 1. A reader will be needed. This product is compatible with the mainstream readers in the market. 2. A pipette is also needed.

Q: What should I do if I don't have a reader?

A: You can choose our gel clot endotoxin test assay. This product doesn't require a reader. Only simple instruments will be needed, such as a pipette, thermostat, and shaker.

Q: What is the difference between the kinetic chromogenic endotoxin testing kits and gel clot endotoxin testing kit? 

A: Learn the difference between gel clot vs. chromogenic vs. turbidimetric methods.

Q: What should I do if the consumables in the reagent kit are not enough?

A: The consumables we provide are sufficient for 96 tests. If the consumption is high and the supplies are insufficient, you can purchase the Control Standard Endotoxin, pyrogen-free water, pyrogen-free tubes, and pyrogen-free vials separately.

Q: Is your kinetic chromogenic assay compatible with all types of microplate readers?

A: Our kinetic chromogenic TAL/LAL assay is compatible with most mainstream microplate readers on the market. The reader should meet the following requirements:

1. A wavelength range of 340–750 nm
2. Capability to dynamically monitor absorbance changes at 405 nm
3. Incubation capability at 37 °C, as required by both the U.S. and European Pharmacopoeia for TAL/LAL testing

If you are unsure whether your reader is compatible, please feel free to contact us before purchasing. We would be happy to review the reader specifications and confirm compatibility for you.

Q: What is the difference between the Kinetic Chromogenic Kit and the Gel-Clot Kit? A: The Gel-Clot Kit is a limit test — it tells you whether endotoxin is above or below a defined threshold (positive/negative). The Kinetic Chromogenic Kit is quantitative — it generates an EU/mL value from a standard curve using 405 nm absorbance kinetics. Choose kinetic chromogenic when you need actual concentration data, high throughput, or audit-ready documentation.

Q: Do I need a dedicated endotoxin reader?

A: No. The kit is compatible with any standard microplate reader that measures absorbance at 405 nm. No specialized endotoxin instrument is required. Compatible readers include BioTek, Molecular Devices, BMG Labtech, and most other common lab plate readers with kinetic monitoring capability.

Q: Is this kit compliant with USP <85> Bacterial Endotoxins Test?

A: Yes. The kinetic chromogenic method is one of three official methods recognized under USP <85>, EP 2.6.14, and JP 4.01. The kit includes all components needed for method validation including Control Standard Endotoxin and quality control samples.

Q: Does the kit include microplates and all reagents?

A: Yes. The kit is fully self-contained and includes LAL/TAL reagent, chromogenic substrate, Control Standard Endotoxin (CSE), quality control sample, sample diluent, reconstitution buffer, and 96-well LAL reagent-grade microplates. No separate reagent sourcing is required.

Q: Can I use this kit for medical device extract testing?

A: Yes. The kinetic chromogenic format is well-suited for medical device extract testing, where inhibition testing and quantitative endotoxin recovery data are typically required for method validation under USP <85> and ISO 10993-11.