Better Human DNA Fragment Analysis Kit

Core Unique Advantages

• Fragment-Specific Multiplex Detection: The only kit in its class to simultaneously quantify four key human DNA fragment sizes (66 bp, 150 bp, 200 bp, 528 bp) in a single qPCR workflow—critical for analyzing DNA fragmentation during bioprocessing (e.g., cell lysis, purification). Even the 500+ bp long fragment achieves nearly 100% amplification efficiency, ensuring no fragment is overlooked in your QC testing.
• Ultra-Sensitive Quantitation with Anti-Contamination Design: Boasts a Limit of Detection (LoD) of 30 fg/μL and uniform Limit of Quantification (LOQ) across all four fragments, enabling femtogram-level human residual DNA detection. Integrated UDG enzyme eliminates amplification product contamination—a common pain point in qPCR-based DNA testing—while an internal positive control (IPC) validates the performance of every individual PCR reaction, eliminating false negatives.
• Rapid Streamlined Workflow: No complex sample preparation protocols or specialized training required—30 minutes only for sample prep, with a single ready-to-use qPCR reagent mix to reduce hands-on time and human error. The entire assay (sample prep + qPCR amplification + fragment quantitation) is completed in just 3 hours, significantly accelerating bioprocess QC timelines compared to traditional fragment analysis methods (e.g., gel electrophoresis).
• Exceptional Accuracy & Reproducibility: Delivers a recovery rate of 70%-130% across all linear range concentrations, with a coefficient of variation (CV) of <20% for all four fragment sizes—ensuring reliable results even in complex biotherapeutic matrices. Amplification efficiencies for all fragments range from 99% to 101%, guaranteeing consistent, batch-to-batch performance for routine QC and process development.

Kit Performance & Validation

1.Amplification Efficiency: 99%-101% across all four fragment sizes (66 bp to 528 bp), including long 500+ bp fragments that challenge most qPCR assays.

2.Accuracy: Average detection concentration aligns closely with theoretical values across 30 fg/μL to high-concentration samples, with accuracy deviation within an acceptable range for regulatory QC.

3.Precision: CV values as low as 8.56% for key fragment sizes (70 fg/μL 66 bp), with all tested concentrations showing CV <20%—meeting strict GMP requirements for data reproducibility.

4.Recovery: 70%-130% recovery rate for spiked samples in diverse bioprocess matrices (cell culture supernatants, purified protein formulations), validating performance in real-world testing scenarios.

Why Choose Our Human DNA Fragment Analysis Kit?

Key Applications

• Human cell line-derived biotherapeutic production QC (monoclonal antibodies, fusion proteins)
• Human plasmid DNA fragment analysis in bioprocessing
• In-process sample testing for human host-cell DNA residuals (cell culture, purification, formulation)
• Final biotherapeutic product human residual DNA fragment quantitation
• Vaccine manufacturing (human cell line-based) residual DNA fragment analysis
• Bioprocess development and scale-up (tracking DNA fragmentation during process optimization)
• Regulatory compliance testing for human residual DNA in biopharmaceuticals

Technical Specifications

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