Associates of Cape Cod (ACC)

LAL reagents are primarily used to test for endotoxins in injectable pharmaceuticals, biological products, and medical devices. They are also used in renal dialysis centers and a wide range of other applications.

Product Stability

• CSE is reconstituted with LRW or equivalent, and is stored at 2–8°C before and after reconstitution. Once reconstituted, the maximum storage time for the different CSE preparations is 10 ng/vial: 7 days, 0.5 µg/vial: 4 weeks, 125 µg/vial: 3 months. *CSE should not be frozen.
• The reconstituted lysate is stable for 24 hours at 2–8°C or for two weeks at -20°C or colder if frozen immediately after reconstitution. Reconstituted Chromo-LAL lysate may be frozen and thawed once.
• Once reconstituted, Pyrochrome is stable for 8 hours when stored at 2–8ºC.
• Pyrosate is stable at room temperature and does not require refrigeration for shipping or storage.
• The reconstituted lysate is stable for 24 hours at 2–8°C or for up to 3 months at or below -20°C. May be frozen onceand will retain activity for as long as 3 months if stored at or below -20°C.
• Once reconstituted, Pyrotell^®-T lysate is stable for 24 hours, if stored at 2–8°C. Pyrotell^®-T lysate may be frozen onceand will retain activity for as long as 3 months if stored at or below -20°C.

Keep Your Method. Make An Impact, With Our New Recombinant Reagent!

PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for Bacterial Endotoxin Testing (BET). Utilizing the same LAL cascade as traditional LAL reagents, while eliminating the potential for 1,3-β-D-glucans cross reactivity, PyroSmart NextGen™ delivers all of the quality and consistency of results you have come to expect from ACC LAL reagents.

PyroSmart NextGen™ can be used for a wide variety of endotoxin tests, ranging from standard water testing to samples requiring high sensitivity, such as intrathecal products and those requiring high dilutions to overcome interference.

Product Sensitivity

The sensitivity for recombinant chromogenic assays is determined by the lowest standard concentration on the standard curve used for the assay. The maximum sensitivity of PyroSmart NextGen™ is 0.005 EU/mL when run in an incubating microplate reader (or 0.001 EU/mL when run in Pyros Kinetix Flex tube reader).

Sample to Lysate Ratio

PyroSmart NextGen™ is used at with an economical volume of 50 µL of reagent per well yielding 50 tests/vial:

• Microplate reader: 1:1 ratio using 50 µL of test sample : 50 µL of reagent