关注公众号
收藏产品 产品详情
组分（Materials Provided）
IDComponentsSizeOPA-R007-01E1A&SV40LTA Primer & Probe Mix550 μLOPA-R007-022×qPCR Master Mix1.6 mLOPA-R007-03Linearize DNA Control 4×10⁸ copies/μL50 μLOPA-R007-04DNA Dilution Buffer1.5 mL×3产品概述（Product Overview）
E1A&SV40LTA resDNA Quantitation Kit is designed for quantitative detection of residual E1A and SV40LTA 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 in one reaction. The lower limit of quantitation is 40 copies/µL. All procedures are typically in less than 4 hours.
Use the kit after you extract residual DNA from test samples. To achieve the best performances, resDNA Sample Preparation Kit (Magnetic Beads) (Cat. No. OPA-R005) is commanded for DNA extraction.
应用说明（Application）
The kit is used for quantitative detection of residual E1A&SV40LTA DNA in biopharmaceutical production.
For use in quality control/manufacturing process only.
It is for research use only.
产品特性（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 ISO 13485 standard facility.
存储（Storage）
Unopened kit should be stored at -15℃ to -25℃ upon receiving.
质量管理控制体系（QMS）
推荐产品
数据展示
典型数据-Typical Data
Please refer to DS document for the assay protocol.
Figure 1. High sensitivity and broad dynamic range using the E1A&SV40LTA resDNA Quantitative Kit. (A) Typical analysis results of obtained with E1A DNA Control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (B) The standard curve of the E1A DNA Control 10-fold dilution series. PCR efficiency should be 90-110%. (C) Typical analysis results of obtained with SV40LTA DNA Control Standard 1 (4×10⁶ copies/µL) to 6 (4×10 copies/µL). (D) The standard curve of the SV40LTA DNA control 10-fold dilution series. PCR efficiency should be 90-110%.
To evaluate the specificity of assay using E1A&SV40LTA resDNA Quantitation Kit, no template samples spiked with unrelated DNA were tested. Results shown in the following Table. Unrelated DNA (CHO, Vero, Pichia yeast) were not detected in assay, and the values of E. coli and MDCK were outside the range of standard curve (4×10⁶ copies/µL to 4×10 copies/µL).
To evaluate the recovery of assay using E1A&SV40LTA resDNA Quantitation Kit, three different concentrations of DNA samples were tested. Results shown in the following Table. All samples had recoveries between 78%-100%.
用户评价 发表评论
联系我们 
项目合作 