KINETIC CHROMOGENIC METHOD REAGENTS
Performing the Test The Pyrochrome ® sample mixture is incubated in an optical reader at 37±1°C and read at a wavelength of 405 nm. No pre-incubation is required and results can be available within 1 hour. However, time to results is dependent on the required assay sensitivity. Software will analyze the data to provide endotoxin results. Reconstitution Pyrochrome ® lysate is reconstituted with an optimized Pyrochrome ® reconstitution buffer (C1500-5). Pyro- chrome ® can also be reconstituted with Glucashield ® buffer (CG1500-5), a (1 g 3)- b - D -Glucan inhibiting buffer, to render the assay endotoxin specific. Stability Once reconstituted, Pyrochrome ® is stable for 8 hrs. when stored at 2–8ºC. Packaging Pyrochrome ® is offered with a choice of reconstitu- tion buffer and is recommended for use with the 10 ng/vial Control Standard Endotoxin (CSE, EC010-5). Certificates of Analysis, specific to the Pyrochrome ® and CSE lot, can be obtained from ACC or online at www.acciusa.com. Pyrochrome ® Chromogenic Test Kit 3.2 mL/vial (approx. 60 tests/vial) Each kit contains Pyrochrome ® and a buffer #C1500-5 Pyrochrome ® with Reconstitution Buffer 5 pack (300 tests) #C1500-25 Pyrochrome ® with Reconstitution Buffer 25 pack (1500 tests) #CG1500-5 Pyrochrome ® with Glucashield ® Buffer 5 pack (300 tests) #CG1500-25 Pyrochrome ® with Glucashield ® Buffer 25 pack (1500 tests)
The BET reagent is formulated with a synthetic substrate which produces a chromophore when cleaved by endotoxin activated enzyme. The test is read in a tube reader or an incubating microplate reader. Pyrochrome ® Reagent Chromogenic Endotoxin Testing
Pyrochrome ® can be used for a wide variety of sample types, ranging from standard water testing to samples requiring high sensitivity, such as intra- thecal products and those requiring high dilutions to overcome interference. Sensitivity The maximum sensitivity of Pyrochrome ® is 0.001 EU/mL when run in Pyros Kinetix ® Flex tube reader or incubating microplate reader with Glucashield ® Buffer. Sample to BET Ratio In the Pyros Kinetix ® Flex tube reader, Pyrochrome ® can be used at an economical ratio of 4:1 using 50 μL of reagent per well or at 1:1 using 100 μL/well. In a microplate reader, the reagent is used at a ratio of 1:1 and a volume of 50 μL/well (60 tests/vial) or 100 μL/well (30 tests/vial).
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