Products Food Safety & Microbiology >Rapid Pathogen Detection


Gel-Clot

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Pyrotell was the first LAL 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 resiliant to interfering substances. The gel-clot test does not require sophisticated equipment and software and is the simplest LAL 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 LAL Ratio

Reconstituted Pyrotell reagent is used at a ratio of 1:1 and a volume of 100 μL/test.



Cat No. Concentration (Eu/mL) Qty
#G5003-5 0.03 EU/mL 5 pack
#G5006-5 0.06 EU/mL 5 pack
#G5125-5 0.125 EU/mL 5 pack
#G5250-5 0.25 EU/mL 5 pack

Pyrosate® Kit

The Pyrosate kit is developed as an easy-to-use LAL gel-clot test. The assay does not require special training or laboratory supplies. 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.

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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.

Cat No. Concentration (Eu/mL) Qty
#PSD030-10 Pyrosate 0.03 EU/mL 10-Test Kit includes sample test tubes and positive product control test tubes
#PSD125-10 Pyrosate 0.125 EU/mL 10-Test Kit includes sample test tubes and positive product control test tubes
#PSD250-10 Pyrosate 0.25 EU/mL 10-Test Kit includes sample test tubes and positive product control test tubes


Turbidimetric

Pyrotell®-T

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Pyrotell-T is used to quantify endotoxin in kinetic turbidimetric tests. Pyrotell-T can be used with the Pyros Kinetix® Flex tube reader and incubating microplate readers. When used with the Pyros Kinetix Flex tube reader, Pyrotell-T gives a highly economic, flexible and sensitive LAL assay.

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 LAL Ratio

The ratio of sample to LAL is determined by personal preference and sample chemistry (interference patterns). Reconstituted Pyrotell-T LAL reagent is used at a ratio of 1:1 or 4:1 and a LAL volume of 100 μL/well (48 tests/vial) or 50 μL/well (96 tests/vial).



Cat No. Qty
#T0051-5 5 pack (250 tests)


Chromogenic

Pyrochrome®

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Pyrochrome is a versatile quantitative reagent that is used to perform kinetic or endpoint assays. It is a sensitive and flexible reagent that can be used for testing in compliance with the USP, EP and JP bacterial endotoxins test chapter. Pyrochrome is offered with either Pyrochrome Buffer or for endotoxin-specific testing, with Glucashield® Buffer. Pyrochrome can be used with the new Pyros Kinetix® Flex tube reader at a 1:1 and economical 4:1 sample to LAL ratio.

Pyrochrome 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.

It is also offered in a diazo kit for endpoint tests. (The diazo reagents shift the absorption wavelength making it especially useful for testing samples with color interference.)

Sensitivity

The sensitivity for chromogenic assays is determined by the lowest standard concentration on the standard curve used for the assay. The maximum sensitivity of Pyrochrome is 0.001 EU/mL when run in Pyros Kinetix Flex tube reader or incubating microplate reader with Glucashield Buffer.

Sample to LAL Ratio

In the Pyros Kinetix Flex tube reader, Pyrochrome can be used at an economical ratio of 4:1 using 50 μL of reagent per well or at 1:1 using 100 μL/well. In a microplate reader, the reagent is used at a ratio of 1:1 and a volume of 50 μL/well (60 tests/vial) or 100 μL/well (30 tests/vial).



Cat No. Qty
#C1500-5 5 packs (300 tests)
#CG1500-5 5 packs (300 tests)


Reagents/Accessories

Control Standard Endotoxin (CSE)

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Control Standard Endotoxin (CSE) is a widely used standard for endotoxin testing. It is a purified extract from E.coli O113:H10, the same strain used for the United States Pharmacopeia and the European Pharmacopeia Reference Standard Endotoxin (RSE).

CSE is an economic alternative to the RSE. CSEs are standardized against the RSE as indicated on the Certificate of Analysis, so the results can be reported in Endotoxin Units (EU) and International Units (IU). CSE can be used for all routine LAL testing. A 10 ng/vial CSE is made specifically for use with our Pyrochrome chromogenic reagent.

Depyrogenation Controls

In addition to their use as standards for controlling LAL test, the 0.5 μg CSEs can be used for validation of depyrogenation processes. They may be used directly, without reconstitution, as depyrogenation indicators (recommended for 0.5 μg) or can be reconstituted and endotoxin added to challenge articles (recommended for 125 μg).



Cat No. μg/vial Packaging
#E0005-1 0.5 μg/vial 1 pack
#E0125-1 125 μg/vial 1 pack
#EC010-5 10 ng/vial 5 pack

LAL Reagent Water (LRW)

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LRW is intended for reconstitution of LAL reagents and CSE, and to dilute samples and standards for LAL assays. LRW is not for human or animal injection. LRW contains less than 0.001 EU/mL endotoxin and less than 1.56 pg/mL glucan.



Cat No. Vol/Plastic Bottle
#WP1001 100mL

Pyrotubes

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Cat No. Size Type Tubes/Pack Packs/Carton
#TK100-10 8 x 75 mm Borosilicate Glass for Pyros Kinetix Flex 50 10
#TS050-10 10 x 75 mm Soda Lime Glass for Gel-clot Method 50 10
#TB240-5 12 x 75 mm Borosilicate Glass (for dilutions only) 40 5
#TB013-5 13 x 100 mm Borosilicate Glass (for dilutions only) 18 5

Pyrosol LAL Reconstitution Buffer

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Pyrosol is an FDA licensed buffer for reconstituting Pyrotell Multi-Test Vial or Pyrotell-T reagents. It is used for testing electrolytes, strongly buffered solutions (especially bicarbonate buffers), and solutions for which it is difficult to adjust pH into the required range. Pyrosol buffer is also available with a pH indicator for gel-clot applications.



Cat No. Type mL/vial Pack
#BC051-5 Pyrosol Buffer with pH indicator 5.5 5

Glucashield (1→3)-β-D-Glucan Inhibiting Buffer

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Glucashield buffer is used to reconstitute LAL and render the reagent insensitive to (1→3)-β-D-Glucan interference by effectively blocking the Factor G pathway of the endotoxin clotting cascade. For use with Pyrotell Multi-Test Vials, Pyrotell-T, Pyrochrome and Chromo-LAL.



Cat No. Type mL/vial Pack
#GB051-5 Glucashield Buffer 5.5 5


Equipments

Pyros® EQS

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The Pyros® EQS is intuitive, easy-to-use software that is designed specifically for endotoxin testing with the Pyros Kinetix® and Pyros Kinetix® Flex tube readers.

Pyros EQS is a sophisticated 21 CFR Part 11 Compliant, software solution that provides efficient, accurate analysis and reporting. The software writes to an Oracle® database*, the industry standard in data security. It has multiple access levels for improved security, detailed audit trails, and built-in trending by date range, technician, sample type and LAL lot. The software provides enhanced reporting options, flexible operation modes and incorporates electronic signatures, as well as a supervisor sign-off on completed tests. The application also offers two choices for calculating Coefficient of Variations (CVs), and a new summarized Pass/Fail Report. Pyros EQS is LIMS compatible through multiple export options.

Software Validation Protocols

Validation Protocols provide the end user with a comprehensive set of integrated documents to guide them through the system validation process. A Validation Plan outlines the tasks and documentation required to perform the validation. A Requirements Specification, the foundation of the validation process, clearly delineates the system’s required functions and expected performance. Detailed instructions guide users step-by-step through the IQ/OQ, and PQ processes. Stress Test procedures are included as well as Change Control and Maintenance guides.



Cat No. Type
#PEQS11 Pyros EQS Software with Manual (21 CFR Part 11 Compliant)
#PEQS11-VAL-PKF Pyros EQS Validation Protocol Pkg (for Pyros Kinetix Flex)

Pyros Kinetix® Flex

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The Pyros Kinetix® Flex and Pyros® EQS 21 CFR Part 11 compliant Software combine to provide a complete system for efficient, accurate endotoxin testing.

The Pyros Kinetix Flex tube reader is available in three configurations: 32, 64 or 96 eight mm wells. Each well has a detector that identifies changes in the optical density of a sample. In addition, each well is independently timed, allowing the operator to add more samples while a run is in progress.

Features

  • Precise Temperature Control—incubator temperature is held to 37°C ± 0.5°C
  •  Solid State Design—low maintenance
  • Two wavelength settings
  •  Uses Low Cost Depyrogenated Disposables

Advantages

  • Broad Sensitivity Range: No other system is more sensitive; As high as 0.001 EU/mL with Pyrotell®-T or Pyrochrome® lysate
  • Increased Efficiency: The ability for end-users to add samples to an existing run in order to efficiently utilize all wells. Software provides quantitative sample results while assay continues to run
  • Flexible Testing: Variable volumes and ratios can be utilized; ability to maximize product MVD (Maximum Valid Dilution)
  • Reduced Lysate Usage: As little as 50 μL per test
  • Independently timed wells: Allows for more samples to be added to a continuous run



Cat No. Type
#PKF32 32 well Pyros Kinetix Flex* Incubating Kinetic Tube Reader
#PKF64 64 well Pyros Kinetix Flex* Incubating Kinetic Tube Reader
#PKF96 96 well Pyros Kinetix Flex* Incubating Kinetic Tube Reader

 Incubating Microplate Readers

 

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High quality optics and rugged design are the hallmarks of the ELx808™ Absorbance Microplate Reader. The 340 nm – 900 nm wavelength range encompasses a wide range of potential applications for this multichannel reader. The ELx808 offers unsurpassed superior 4-Zone Temperature Control, providing excellent stability for temperature sensitive assays like endotoxin analysis and long-term bacteria and yeast growth studies. Through the optional control of Gen5™ Data Analysis software, the ELx808 becomes an effi cient, easy to use and powerful system for a variety of microplate based applications. Endpoint, kinetic and linear well scanning measurements are easily defi ned and analyzed through Gen5, but when bench space is a premium or a computer interface isn’t available, the ELx808 offers extensive user-programmable software with curve-fi tting, data transformation and other analysis options.

Features

  •  4-Zone Temperature Control option provides improved reproducibility for temperature-sensitive assays
  • Fast kinetic measurements in intervals as short as 6 seconds with multiple kinetic analysis options
  • Superior optical design incorporates staggered optics to eliminate channel-to-channel cross-talk
  • Endpoint, kinetic and linear well scanning read modes
  • Extensive onboard programming and data analysis

Applications:

  • ELISAs / EIAs
  • Endotoxin Testing
  • Enzymatic Activity
  • Bacterial growth studies
  • Fast Kinetic assays



Cat No. Type
ELx808 96-well plates, 380-900 nm wavelength range and shaking