KINETIC TURBIDIMETRIC METHOD REAGENT
The optical density (turbidity) increase that accompa- nies the clotting reaction is read in the Pyros Kinetix ® Flex tube reader or in an incubating microplate reader. Pyrotell ® -T Reagent Turbidimetric Endotoxin Testing
to lysate ratio of 1:1 or 4:1 and volume of 100 μL/well (48 tests/vial) or 50 μL/well (96 tests/vial), respectively. Performing the Test The Pyrotell ® -T sample mixture is incubated in an optical reader at 37±1°C and read at a desired wave- length depending on the instrumentation and user choice. The time of incubation is dependent on the lowest standard concentration in the standard curve. Software is used to analyze the standard curve and calculate the endotoxin concentrations. Reconstitution Pyrotell ® -T may be reconstituted with 5 mL of LAL Reagent Water (LRW), Pyrosol ® buffer, or Glucashield ® buffer, depending on the demands of the sample be- ing tested. Pyrosol ® buffer provides improved kinetics and extra pH buffering capacity. Glucashield ® buffer, a (1 g 3)- b - D -Glucan inhibiting buffer, is used to render the assay endotoxin specific. Stability Once reconstituted, Pyrotell ® -T is stable for 24 hours, if stored at 2–8°C. Pyrotell ® -T may be frozen once and will retain activity for as long as 3 months if stored at or below -20°C. Packaging Pyrotell ® -T is available in multi-test vials. Each vial contains reagent for approximately 96 tests (when used with the Pyros Kinetix ® Flex tube read- er and 4:1 sample to BET ratio) or 48 tests (when used with 1:1 ratio and/ or in a microplate read- er). It is recommended for use with the 0.5 μg/ vial Control Standard Endotoxin (CSE, E0005-1). Certifi- cates of Analysis, specific to the Pyrotell ® -T and CSE lot, can be obtained from ACC or online.
Pyrotell ® -T formulation is a versatile and cost effective solution for the determination of endotoxin. It can be used with the Pyros Kinetix ® Flex tube reader and incubating mi- croplate readers. When used with the Pyros Kinetix ® Flex tube reader, Pyrotell ® -T is a highly economic, flexible and sensitive BET assay. Turbidimetric reagent It can be used for a wide variety of tests, ranging from water testing to samples requiring high sensitivity, such as intrathecal products and those requiring high dilutions to overcome interference. Sensitivity When used in a Pyros Kinetix ® Flex tube reader the maximum sensitivity is 0.001 EU/mL. The unique formulation of Pyrotell ® -T allows a wide selection of standard curves to be used, giving the user flexibility, speed and ease in performing assays. Sample to BET Ratio The ratio of sample to BET is determined by personal preference and sample chemistry (interference patterns). Reconstituted Pyrotell ® -T reagent is used at a sample
Pyrotell ® -T Multi-Test 5 mL/vial (approx. 50 tests/vial) #T0051-5 5 pack (250 tests) #T0051-25 25 pack (1250 tests)
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