Qiagen, EN32-001, Saltonase ELISA Kit (5 x 96)

To extend the shelf life of the kit, components are packed in two separate boxes based on their storage requirements: Box 1 is intended for storage at 2–8°C, while Box 2 should be kept at –30 to -15°C. This separation helps maintain the stability and performance of the reagents throughout the kit's intended shelf life.
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Features

- Highly sensitive and specific using monoclonal antibodies
- The assay has a broad operating range of 31.25 to 2000 pg/mL, measured at OD450
- The detection method is colorimetric
- Provided in a practical format of 8-well strips

Product Details

The Saltonase ELISA Kit (5 x 96) is a high-performance assay designed for the quantitative detection of Saltonase endonuclease, including MBG and GMP-grade formats. Engineered for precision, the assay utilizes highly specific monoclonal antibodies to ensure consistent, reliable results with a detection limit of as low as 31.25 pg/mL.

Optimized for bioprocessing applications, Saltonase is an endonuclease that removes nucleic acids under high-salt and variable pH conditions. In addition, the ELISA kit is ideal for monitoring residual Saltonase levels in in-process samples and verifying its removal in downstream processing and final product.

Each kit includes five pre-coated 96-well microplates in convenient 8-well strip formats and comes with ready-to-use reagents. To extend shelf life and maintain reagent stability, the kit components are packaged in two separate sets. The kit supports a wide quantification range of 31.25–2000 pg/mL and provides sufficient materials for up to 480 measurements.

Performance

Assay characteristics: Specification
Sensitivity: LOQ: 30 pg/mL
Broad working range: 31.25–2000 pg/mL
Specificity: Monoclonal Antibodies used Low interference from the sample matrix
Accuracy: RE +/- 20%
Processing time: 240 min
Flexibility: 8-well strip plate format

Principle

- Standards or samples are added to the wells, allowing any residual Saltonase to bind to the immobilized capture antibody.
- After a wash step to remove unbound material, a biotin-labeled anti-Saltonase antibody (Detection A) is introduced, binding to the captured enzyme.
- Following another wash, Streptavidin-Poly-HRP (Detection B) is added. This binds to the biotin-labeled antibody, forming a stable complex.
- After a final wash, a substrate solution is added. A color reaction develops in proportion to the amount of Saltonase present in the sample.
- The reaction is stopped, and the absorbance is measured using a standard microplate reader.

The Saltonase ELISA Kit (5 x 96) utilizes a quantitative sandwich enzyme immunoassay format to ensure high specificity and sensitivity. During the procedure:

This precise and reliable method enables accurate quantification of Saltonase across a broad dynamic range, making it ideal for both process development and quality control applications.

Procedure

Quality Control

In accordance with the ISO-certified Quality Management System of QIAGEN, each lot of Saltonase ELISA Kit (5 x 96) is tested against predetermined specifications to ensure consistent product quality.

Usage

For optimal performance, users should follow the step-by-step protocol and reagent preparation guidelines outlined in the Saltonase ELISA Kit (5 x 96) Handbook. The assay is designed for ease of use with standard laboratory equipment and includes clear instructions for sample preparation, standard curve generation, and result interpretation.

Before beginning, ensure all reagents are brought to room temperature and that all standards and samples are run in duplicates or triplicates for reliable results.

Please refer to the handbook for complete instructions, reagent handling and troubleshooting recommendations.

Applications

- Process development support enables monitoring of Saltonase removal during early-stage process optimization, viral vector or vaccine production.
- Downstream purification control confirms effective enzyme removal post-cell lysis, filtration, chromatography and formulation, ensuring product purity and regulatory compliance.
- Routine quality control is designed for reproducible, high-throughput testing across large sample sets with an intra‑ and inter-assay precision.

Accurate quantification of Saltonase endonuclease, including MBG and GMP-grade variants, in process intermediates and final drug products to confirm complete enzyme clearance, including: