THE ORIGINAL GEL-CLOT ASSAY
Reconstitution Pyrotell ® MTV may be reconstituted with BET Reagent Water (LRW), Pyrosol ® buffer or Glucashield ® buffer, a (1 g 3)- b - D -Glucan inhibiting buffer, to render the assay endotoxin specific. Pyrotell ® STV is reconstituted by the sample being tested. Stability Once reconstituted Pyrotell ® MTV is stable for 24 hours if stored at 2–8°C. Pyrotell ® MTV may be frozen once and will retain activity for as long as 3 months if stored at or below -20°C. STVs are used immediately upon addition of the sample. Packaging Pyrotell ® is available in 2 mL (approx. 20 tests/vial) or 5 mL (approx. 50 tests/vial) MTV and STV sizes. STV’s are sold in 5x10 vial packs. Certificates of Analysis, specific to the Pyrotell ® and CSE lot, can be obtained from ACC or online at www.acciusa.com. It is recommended for use with 0.5 μg/vial Control Standard Endotoxin (E0005-1). See page 22 for product vial test quantities.
Pyrotell ® Gel-Clot Endotoxin Testing
ACC’s Pyrotell ® was the first BET reagent licensed by the US FDA. It is easy to use and is available in both economical Multi-Test Vials (MTVs) and convenient Single Test Vials (STVs). Pyrotell ® is a robust reagent, producing firm, easily read clots and is resistant to interfering substances. The gel-clot test does not require sophisticated equipment and software and is the simplest BET test to implement. Sensitivity Pyrotell ® is available in a variety of sensitivities: 0.03 EU/mL; 0.06 EU/mL; 0.125 EU/mL; and 0.25 EU/mL. Sample to BET Ratio Reconstituted Pyrotell ® reagent is used at a ratio of 1:1 and a volume of 100 μL/test. Performing the Test For 2 mL and 5 mL MTV, 100 μL of lysate is mixed with 100 μL of sample in a reaction tube. For STV, 200 μL of sample is added to the vial, which serves as a reac- tion tube. Test tubes are incubated at 37±1°C for 60 minutes ± 2 minutes. A positive test is indicated if the clot remains solid after the inversion of the test tube.
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