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E1A resDNA Quantitation Kit (qPCR), ACROBiosystems (CAT#: STEM-CT-0658-ZJF)

Highlights

High sensitivity for optimal product safety: LLOQ (40 copies/µL) for detection of residue DNA
High specificity: No cross-reactivity with unrelated DNA
Validation: ICH Q2(R2) as Validation of Analytical Procedures

Cat Number: STEM-CT-0658-ZJF

Application: resDNA Detection Kits

Model: OPA-R008

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Description

E1A resDNA Quantitation Kit is designed for quantitative detection of residual E1A DNA in biopharmaceutical productions (cells, viruses, etc.). Based on real-time quantitative PCR (qPCR) method, this kit makes detection the residual DNA rapid and reliable. The lower limit of quantitation is 40 copies/µL. All procedures are typically in less than 4 hours.
Use the kit after you extract host cell DNA from test samples. To achieve the best performances, resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) is commanded for DNA extraction.

Specification

Linearity: R²≥0.99, Eff%:90%-110%
Assay range: 4×10 copies/μL~4×10^6 copies/μL
Accuracy: 80%-120%
Repeatability: CV<15%
Time: 60 minutes
Assay tests: 100 tests
Storage: Store at -15 ~-30C for 12 months

Features

High sensitivity for optimal product safety: LLOQ (40 copies/µL) for detection of residue DNA
High specificity: No cross-reactivity with unrelated DNA
Validation: ICH Q2(R2) as Validation of Analytical Procedures
High-quality: This Kit is manufactured in Gmp facility and alignment with the ISO 13485 standard.

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