Denarase® ELISA Kit — The One-for-All Serratia marcescens ELISA Kit
Sandwich ELISA for quantitative detection of residual Serratia marcescens endonucleases in bioprocess samples.
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Overview
What is Denarase® ELISA Kit — The One-for-All Serratia marcescens ELISA Kit?
Denarase® ELISA Kit — The One-for-all Serratia marcescens Endonuclease Detection Kit
About the Denarase® ELISA Kit
The Denarase® ELISA Kit is a sandwich ELISA for quantitative in vitro measurement of residual Serratia marcescens endonuclease in process-related samples. It detects Denarase®, Denarase® High Salt, and Benzonase® — providing a unified assay solution for monitoring any S. marcescens endonuclease across your downstream bioprocessing workflow.
Intended for research and manufacturing use (process development and quality control). Not for diagnostic procedures.
Detection Principle
Sandwich ELISA. Samples are incubated in 96-well plates pre-coated with a specific monoclonal capture antibody. Bound endonuclease is detected using a biotin-conjugated monoclonal detector antibody, streptavidin-HRP conjugate, and TMB colorimetric substrate. Absorbance read at OD450.
Key Performance Parameters
- Limit of Detection (LOD): 4 pg/mL
- Limit of Quantification (LOQ): 12 pg/mL
- Working Range: ~32–1,000 pg/mL
- Assay Time: ~130 minutes total incubation
- CV (OD450 Assay Control): ≤ 15%
- Capacity: 480 measurements per kit (5 × 96-well plates)
- 15–50× more sensitive than competitor ELISA kits using polyclonal antibodies
- 50% shorter assay time versus competitor kits
Kit Contents
- 5 × Microtest plates (96-well, pre-coated with monoclonal capture antibody)
- Washing Buffer (10×) — 3 × 100 mL
- Dilution Buffer (10×) — 1 × 20 mL
- Denarase® Standard (10 µg/mL) — 1 × 0.1 mL
- Detector Antibody (100×) — biotin-conjugated monoclonal antibody, 1 × 0.75 mL
- Enzyme Conjugate (100×) — streptavidin-HRP, 1 × 0.75 mL
- Substrate Solution — TMB One, ready to use, 1 × 75 mL
- Stop Solution — 0.5 M sulfuric acid, 1 × 75 mL
Storage & Stability
- Store at 2–8 °C
- Shelf life: 18 months from production under proper storage conditions
- Shipping temperature may deviate from storage temperature without affecting product quality
Details
Specifications
Applications
Applications & how to use
ELISA
Quantifies a soluble analyte using antibody capture and enzyme-linked detection on a microplate, giving concentration readouts against a standard curve.
Evidence
Validation & QC
Validation data for this product isn’t published yet.
Need specific QC or validation results — titer, purity, endotoxin, or assay data — for your application? Our scientific team can share what is available for this product and lot on request.
Request validation dataManufacturing
How it's made & quality control
Supplier quality control
Batch release specification
\nAppearance: clear, transparent solution. Activity above 250 U/µL by photometric assay. Purity ≥ 99% (standard Denarase®) or ≥ 98% (High Salt) by SDS-PAGE with silver staining. Specific activity above 6 × 10⁵ U/mg. No protease activity detectable. Endotoxin below 0.25 EU/kU by LAL per Ph. Eur. 2.6.14 Method C. Microbial count per Ph. Eur. 2.6.12: aerobic bacteria and yeast or moulds each below 5 cfu per 200 µL.
Clearance validation
\nThe Denarase® ELISA Kit is a monoclonal antibody-based sandwich ELISA for residual Serratia marcescens endonuclease in process samples, covering standard Denarase®, Denarase® High Salt and Benzonase®. Limit of detection 4 pg/mL, limit of quantification 12 pg/mL, working range approximately 32–1,000 pg/mL, assay time approximately 130 minutes. For High Salt, apply a correction factor of 1.46. Benzonase® is a registered trademark of Merck KGaA.
Documents available
\nProduct Information Sheets and Product Specifications for R&D and GMP grades; Validation Guide; guidance on qualifying Denarase® in biopharmaceutical manufacturing; Change Guidance Document for grade transition; US FDA Drug Master File support documentation; ELISA Kit user instructions, kit contents and prevalidation report.
Supplier-level quality statement. For lot-specific results, request the Certificate of Analysis for your batch.
Resources
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Answered by our team
Questions from researchers
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Research using this product
Every paper below mentions this product's catalogue number (or product name) in its full text — a text match, not a verified citation. Each entry shows what was measured, the sample type where the paper states it, and the sentence the catalogue number appears in, and a link to the figure showing that data — so you can confirm the use case before citing.
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