Reagents and endotoxins for LAL test

The LAL reagents and the CSE (Control Standard Endotoxin) are produced in the USA and, by agreement with the parent company, cannot be purchased online from this site. We invite you to contact us to receive prices and technical documentation. We supply the reagents to perform the LAL gel-clot test (multiple tests and single tests), the kinetic-turbidimetric and the kinetic-colorimetric.


Reagents for LAL test, bacterial endotoxin test

The LAL reagent appears as a fine freeze-dried powder, which can be stored for long periods of time and must be reconstituted with water immediately before use.

As regards the turbidimetric or chromogenic kinetic test, the LAL reagent comes in a vial of approximately 3 or 5 ml.

Regarding the gel-clot test, two types of vials are available:

vials for multiple tests: they must be reconstituted with water and dispensed into the test tubes containing the samples. One vial allows you to perform 50 tests (5 ml)

tubes for single tests: each tube contains the reagent already dosed for one test (0.2 ml), to which the sample can be added.

When choosing the most appropriate lysate, the concept of "sensitivity" comes into play, i.e. the minimum concentration of detectable endotoxin. Usually the reagents have sensitivity 0.03 EU/ml - 0.06 EU/ml – 0.125 EU/ml - 0.25 EU/ml. This means that they will be able to detect endotoxin concentrations equal to or greater than the sensitivity value in the samples under examination.


Control and reference endotoxins

The LAL test must always be performed using the LAL reagent together with a purified endotoxin, be it Control Standard Endotoxin (CSE) produced by the same manufacturer as the LAL reagent or Reference Standard Endotoxin (RSE or BRP) produced by USP and EP respectively. Endotoxins allow you to prepare positive controls and standard curves. RSE and BRP are independent of the lysate lot while CSE is coupled to the lysate via a lot-specific certificate.


Endotoxins for validation of dry depyrogenation processes

The Endotoxin Challenges are used in the validation of dry heat depyrogenation cycles. The ability of a particular oven cycle to destroy/inactivate endotoxin is measured by comparing the endotoxin level in treated vials and untreated controls. The United States Pharmacopeia (USP) states that the endotoxin indicators used in depyrogenation process challenges allow for accurate indication of at least a 3-log reduction.

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