Associates of Cape Cod, Inc. (ACC), is one of the world’s largest manufacturers of products developed to detect and quantify gram-negative bacterial endotoxins and (1g3)-ß-D-glucans. Our products are used worldwide by leading pharmaceutical and medical device companies to ensure the safety of their parenteral drugs, biological products, and medical devices. Our goal is to provide the best products and services, as well as the best technical support and customer service in our industry, to enhance the productivity and efficiency of all our customers. We are ISO 13485: 2003 certified, our laboratories are FDA inspected and DEA licensed. Our Beacon Diagnostics® laboratory is CLIA certified.
Associates of Cape Cod, Inc., (ACC) is pleased to introduce Pyrosate®, a new FDA licensed version of our rapid endotoxin detection kit. Pyrosate is well suited for performing endotoxin assays in full compliance with the Bacterial Endotoxins Test, USP chapter <85>. Pyrosate has been developed as an easy-touse Limulus Amebocyte Lysate (LAL) gel-clot test that enables rapid testing and does not require special laboratory supplies. The easy-to-follow, step-by-step illustrated instructions allow the user to set up assays within minutes. In addition to FDA licensure, the Pyrosate® Kit is now available in sensitivities of 0.03 EU/mL, 0.125 EU/mL and 0.25 EU/mL, in both 10-pack and 30-pack formats. With the introduction of this licensed version, in addition to research and water testing, Pyrosate is ideal for dialysis centers, compounding pharmacies, and pharmaceutical and medical device companies.
Performing the Test
The Pyrosate® Kit is a rapid gel-clot test that contains a 2λ* 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 (1g3)-ß-D-glucans. This endotoxin specific reagent does not require additional blocking buffers.
Pyrosate® is reconstituted directly with the sample by adding 0.5 mL to the sample tube (SPL). After approximately 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.
Pyrosate® is stable at room temperature and does not require refrigeration for shipping or storage.
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