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CapeCod 1 – Bacterial Endotoxin Testing
I. Chromo-LAL – Kinetic chromogenic formulation
– Chromo-LAL lysate is lyophilized with substrate reagent and buffers. It is optimized for the kinetic chromogenic LAL test method in microplate readers. – Chromo-LAL is a buffered, stable and robust lysate, suitable for quantitative testing of a wide range of samples.
– Pyrotell ® -T lysate is used to quantify endotoxin in kinetic turbidimetric tests. Pyrotell-T lysate can be used with the Pyros Kinetix ® tube reader and also incubating microplate readers. When used with the Pyros Kinetix tube reader, Pyrotell-T gives a highly economic, flexible and sensitive LAL assay.
– When used in a Pyros Kinetix tube reader, the maximum sensitivity is 0.001 EU/mL, which is 5 times more sensitive than any other LAL assays. The unique formulation of Pyrotell-T lysate allows a wide range of standard curves to be used, giving the user flexibility, speed, and ease in performing assays. When used in a microplate reader, the maximum sensitivity is 0.005 EU/mL.
-Pyrotell ® lysate was the first LAL gel-clot reagent licensed by the US FDA. It is easy to use and is available in both economical multi-test vials and convenient Single Test Vials (STV's). Pyrotell lysate is a robust reagent, producing firm, easily read clots and is resistant to interfering substances. The gel-clot test does not require sophisticated capital equipment and software and is the simplest LAL test to implement.
– Pyrotell lysate is available in multiple sensitivities: 0.03 EU/mL; 0.06 EU/mL; 0.125 EU/mL; 0.25 EU/mL.
1.Control Standard Endotoxin (CSE) is a widely used standard for endotoxin testing. It is a purified extract of E. coliO113:H10, the same strain used for the United States Pharmacopeia and the European Pharmacopeia reference standard endotoxin (RSE).
CSE is used as an economic alternative to the RSE. CSEs are standardized against the RSE as indicated on the Certificate of Analysis, so that results can be reported in Endotoxin Units (EU) and International Units (IU). CSE can be used for all LAL testing. A 10 ng/vial CSE is made specifically for use with our Pyrochrome ® chromogenic reagent.
2. LRW is specially processed water intended for reconstitution of LAL reagents and CSE, and to dilute samples and standards for LAL assays. Not for human or animal injection. LRW contains less than 0.001 EU/mL endotoxin and less than 1.56 pg/mL glucan.
3. Our Pyroclear ® Pyrotube ® dilution tubes are for laboratory use only and are certified free of interfering endotoxins and glucans.
4. Our Pyroclear ® Precision Pipette Tips are certified free of interfering endotoxins and glucans.
5. Our Pyroclear ® Pyroplate ® 96-well microplates are certified free of interfering endotoxins and glucans.