resDetect

The resDetect™ E1A&SV40LTA resDNA Quantitation Kit is designed for the quantitative detection of residual E1A and SV40LTA DNA in biopharmaceutical production processes, such as those involving cells and viruses. Utilizing a real-time quantitative PCR (qPCR) method, this kit enables rapid and reliable detection of residual DNA in a single reaction, with a lower limit of quantitation set at 40 copies/µL. The entire procedure typically takes less than four hours to complete.

For optimal performance, it is recommended to use the resDNA Sample Preparation Kit (Magnetic Beads) for DNA extraction prior to using this kit. This ensures consistency in the buffers used during both sample preparation and residual DNA quantitation, supporting reliable and accurate results.

Features

• High Sensitivity: Detects residual DNA with a lower limit of quantitation of 40 copies/µL, ensuring optimal product safety.
• High Specificity: No cross-reactivity with unrelated DNA, such as CHO, Vero, and Pichia yeast, was detected.
• Validation: The kit is validated according to ICH Q2(R2) guidelines for analytical procedures.
• Quality Manufacturing: Produced in an ISO 13485 standard facility.

The kit is intended for use in quality control and manufacturing processes and is designated for research use only.

Technical Specifications

The kit includes components such as E1A&SV40LTA Primer & Probe Mix, 2×qPCR Master Mix, Linearize DNA Control, and DNA Dilution Buffer. It is crucial to follow the recommended protocols to ensure the accuracy and reliability of results.

Overall, the resDetect™ E1A&SV40LTA resDNA Quantitation Kit offers a robust solution for the detection of residual DNA in biopharmaceutical environments, supporting stringent quality control measures.