Control Standard Endotoxin

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Our Control Standard Endotoxin (CSE) is a lyophilized product composed of a 500-ng vial of endotoxin, purified from E. coli UKT-B strain that serves as an accurate and dependable standard for endotoxin testing.

Key Features

• Endotoxin derived from E. coli UKT-B
• Can be used to prepare controls and standard curves
• Potency of CSE supplied to match each lot of LAL
• Reconstituted CSE can be stored at 2–10°C for 1 month

Control Standard Endotoxin

Q: How should the CSE be prepared?

A: The reconstitution volume of the CSE depends on the reagent lot it will be paired with in testing. Whether the product is PYROSTAR™ ES-F Series or a Limulus Color KY series, a COA associated with the reagent lot will list the information for the associated CSE lot. The COA is provided or can be accessed at www.wakopyrostar.com for each reagent lot.

Note: When testing with the Limulus Color KY series, the potency is shown on the CSE vial label. Divide the potency (EU/vial) by 1,000 to calculate the volume of LRW needed to reconstitute the CSE for a yield 1,000 EU/mL.

Q: How should the dilution for the gel clot assay be prepared?

A: The dilution series for gel clot assay are two-fold dilutions of the CSE. Based on the reagent’s sensitivity (λ), the two-fold dilutions generate a standard curve of 2 λ, λ, λ/2 and λ/4.

Example: PYROSTAR™ ES-F multi-test reagent labeled sensitivity (λ): 0.015 EU/mL

The final endotoxin (dilution tubes 8, 9, 10 and 11) would be achieved to generate a standard of dilutions to test for the labeled sensitivity of 0.015 EU/mL.

Note: This is an example of how to perform the two-fold dilution. Adjusting the volumes of the LRW and endotoxin is acceptable if the ratios are maintained.

Q: How should dilutions for the kinetic assays be prepared?

A: The dilution series for kinetic assays are typically ten-fold dilutions of the CSE. Based on the reagent’s range the tenfold dilutions generate a standard curve with at least three standards.

Example: PYROSTAR™ ES-F multi-test reagent labeled sensitivity (λ): 0.015 EU/mL has a KTA range of 0.001-10 EU/mL. To reach the highest possible sensitivity, the dilution would be shown as below. The final endotoxin (dilution tubes 4, 5 and 6) would be used to generate the standard curve for KTA testing.

Note: This is an example of how to perform a ten-fold dilution. Adjusting the volumes of the LRW and endotoxin is acceptable as long as the ratios are maintained.