Endonuclease ELISA
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Ultra-Sensitive Quantification of Residual Endonucleases
The PROGEN Endonuclease ELISA is a highly sensitive assay designed for in vitro quantification of endonuclease produced by Serratia marcescens, including DENARASE® and DENARASE® high salt, in your biological samples.
In biological manufacturing processes such as AAV production, monitoring endonuclease levels is crucial for product purity, patient safety, and regulatory compliance. The PROGEN Endonuclease ELISA combines ultra-sensitive, ready-to-use detection with 15–20x higher sensitivity than comparable kits. It enables precise and reliable quantification of residual nucleases, which is a critical quality attribute (CQA) for reliable manufacturing and development of biological products.
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How does Endonuclease ELISA work?
This Endonuclease ELISA kit is a sandwich ELISA performed in a microplate format. A specific monoclonal capture antibody is coated onto wells of a microplate and is used to capture endonuclease from Serratia marcescens present in samples, e.g. cell lysates or purified virus preparations. Captured endonucleases are detected in two steps:
- A biotin-conjugated monoclonal detector antibody (antibody conjugate) binds to the immobilized endonuclease.
- A streptavidin peroxidase conjugate (HRP conjugate) binds to the biotin molecules.
Adding the substrate solution (TMB) results in a color reaction, which is proportional to the analyte concentration present in the wells. The absorbance is measured photometrically at an optical density of 450 nm (reference wavelength between 620-690 nm). The endonuclease concentration in unknown samples can be calculated based on the corresponding DENARASE® standard curve.
What are the key benefits of Endonuclease ELISA?
Ready-to-use
Supplied with a pre-coated microplate and all necessary reagents.Ultra-sensitive detection
Enabled by highly specific monoclonal antibodies – more sensitive than competitor kits.Broad usability
Detects multiple endonucleases of Serratia marcescens (DENARASE®, high-salt DENARASE®, Benzonase®).Efficient Workflow
Total incubation 2 hours – save up to 50% compared to competitor kits.Wide dynamic range
32 pg/ml to 1000 pg/ml (OD450 nm).Limit of Detection (LOD)
4 pg/mlLimit of Quantification (LOQ)
12 pg/mlNo FAQ entries available.
Endonuclease ELISA FAQs
Endonuclease assay provides ultra-sensitive detection with a limit of detection (LOD) of 4 pg/ml and a limit of quantification (LOQ) of 12 pg/ml — 15–20× more sensitive than comparable kits. The dynamic range is 32–1000 pg/ml.
Endonuclease kits remain stable during shipping and short-term storage at room temperature but should be stored at 2–8 °C upon arrival for optimal preservation. All reagents are stress-tested to ensure stability during transport, even under challenging conditions.
The Endonuclease kit is ready-to-use with pre-coated plates and reagents included, highly reproducible, broadly applicable across different endonucleases. It supports efficient workflows (up to 50% shorter incubation compared to competitor kits).
The Endonuclease assay is designed for monitoring residual nucleases during AAV and viral vector production, supporting QC in biologics and recombinant protein manufacturing, and ensuring compliance in CDMOs and CROs. It is for research use only.
In the ELISA kit manual a reference wavelength is given. The primary measurement is taken at 450 nm, so your instrument must include a suitable 450 nm filter. While the reference wavelength (between 620 nm and 690 nm) can be used, it is not strictly required. Dual-wavelength readings can, in principle, improve accuracy by correcting for non-specific optical effects in the plate. When available, reader software will automatically subtract the reference absorbance from the 450 nm signal. However, because the plates included in the kit are of high optical quality, subtracting reference values typically does not provide a noticeable statistical advantage.
This Endonuclease ELISA kit is intended for the quantitative in vitro measurement of an endonuclease of Serratia marcescens. This assay can be used to monitor the presence of endonucleases, such as DENARASE®, DENARASE® High Salt, Benzonase®, or EndoCleave, in process-related samples during process development and quality control. The assay includes the enzyme DENARASE® as a standard to generate the standard curve. When measuring different endonucleases with this assay, for accurate quantification, correction factors may be applied or custom enzyme standards may be used.