[ACC] Product Overview

RAPID ENDOTOXIN DETECTION

Pyrosate ® Kit – Rapid Endotoxin Detection

The Pyrosate ® kit is an easy-to-use FDA Licensed BET gel-clot test allowing for BET compliant endotoxin testing. The assay does not require special training or laboratory supplies and the step-by-step illustrated instructions allow the user to perform assays within minutes. The Pyrosate ® kit provides rapid results and is especially convenient for research, testing water and dialysate. Sensitivity The Pyrosate ® kit is available in sensitivities of 0.25 EU/mL, 0.125 EU/mL and 0.03 EU/mL. The test may be as short as 30 minutes, depending on the sensitivity. Performing the Test The Pyrosate ® kit is a rapid gel-clot test that contains a 2 λ * endotoxin tube (PPC) matched to the sample (SPL) tube for each sensitivity. This feature is unique to the Pyrosate ® assay. The endotoxin tube (PPC) assures that the sample does not interfere with the test, ruling out false negatives. Pyrosate ® is formulated to eliminate false positives due to (1 g 3)- b - D - Glucans. This endotoxin specific reagent does not require additional blocking buffers. Reconstitution Pyrosate ® is reconstituted directly with the sample by adding 0.5 mL to the sample tube (SPL). After approxi- mately 60 seconds of gentle mixing, 0.25 mL is transferred to the endotoxin tube (PPC). The lot-specific incubation time at 37±1°C is given on the Certificate of Compliance. Stability Pyrosate ® is stable at room temperature and does not require refrigeration for shipping or storage.

Product Applications • Hemodialysis

• Water and Water Systems • Filter Industry • Research • Final Product

Product Benefits

• Shorter Assay Time • Endotoxin Specific • No Dilutions Required • No Refrigeration Required • Matched Positive Product Control

Packaging The Pyrosate ® kit is available in a 10 test kit and a 30 test bulk package for each sensitivity. Each kit contains sample test tubes (SPL) and endotoxin test tubes (Positive Product Control-PPC). A Certificate of Analysis, specific to the Pyrosate ® and CSE lot, can be obtained from ACC or online at www.acciusa.com.

* λ (lambda) is the lowest concentration of endotoxin to cause a positive test result under standard conditions.