PyroSmart NextGen™

The First Recombinant Cascade LAL Reagent

NODIA and it’s partner Associates of Cape Cod, Inc. (ACC), are excited to let you know that PyroSmart NextGen™, The Future of Sustainable LAL Recombinant Cascade Reagent Has Arrived!

No Animal Content – Horseshoe Crab Blood Free. 

  • Same Preparation steps
  • Same Instrument
  • Same Cascade

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General

Product Description

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.

PyroSmart NextGen cascade
PyroSmart NextGen pijl

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).

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Protocol outline

  • RSE as a standard (std. curve, PPC)
  • Using validated systems only
  • Coordinated testing allowing for concurrent analysis of the samples by LAL vs. rLAL
  • Using endotoxin specific LALs
  • Results expressed as Relative Recovery %

Study Criteria

  • Relative recovery % is within 50 to 200%

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Traditional vs Next generation

 Conventional LAL ReagentPyroSmart NextGen™ (rCR)Competitor (rFC) Reagent
Year Technology Introduced197720212005
Kinetic AssayKineticKineticEndpoint only
Assay SetupSingle step reconstitutionSingle step reconstitutionRequires three reagents in a 1:4:5 ratio and a 10 min pre-incubation step
Same Standard Plate ReaderIncubating plate or tube reader at 405nmIncubating plate or tube reader at 405nm Fluorescent reader required
Derived From:
Limulus Amebocyte Lysate (LAL)
LALrCR is recombinant LALBased on Carcinoscorpius or Tachypleus
Amebocyte Lysate (CAL/TAL)
Multi-step Cascade PathwayYesYesNo
Endotoxin SpecificNoEndotoxin SpecificEndotoxin Specific
Sustainable Reagent (animal free)NoHorseshoe Crab Blood FreeHorseshoe Crab Blood Free

Extra Information

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
  • Pyros Kinetix® Flex tube reader: 4:1 using 200 µL of test sample : 50 µL of reagent

Test Performance

The PyroSmart NextGen™ reaction mixture is incubated at 37±1°C and read in a microplate reader equipped with a 405–410 nm filter. The time of incubation is dependent on the lowest standard concentration in the standard curve, with 0.005 EU/mL achievable in 2500 seconds in a microplate reader. Software is used to construct the standard curve and calculate the endotoxin concentrations.

Product Reconstitution

PyroSmart NextGen™ is provided as co-lyophilized with the chromogenic substrate and as such it is ready-to-use following a simple reconstitution (using 2.8mL of the supplied reconstitution buffer).

Product Packaging

PyroSmart NextGen™ is a lyophilized product with an excellent shelf life of 3 years since the date of manufacture. 2.8 mL/vial (approx. 50 tests/vial)  (#PNG050-2). 

  • 2 x PyroSmart NextGen™ Reagent
  • 2 x Reconstitution Buffer
 

 This is sufficient for a total of 110 wells (55 wells per vial).