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E1A Residual DNA Fragment (qPCR) Detection Kit
Item number：FE0311A-4×100
Specs：4×100 Reactions
Sell-by date：12 months
Storage conditions：-20℃
Technical support：19503412257
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E1A Residual DNA Fragment (qPCR) Detection Kit

Product Introduction


Since 2015, the U.S. FDA (Food and Drug Administration) has approved seven HEK-derived products, emphasizing that when using HEK293T cells to produce viral vectors, in addition to detecting the SV40 LTA antigen sequence, residual adenovirus E1A sequences must also be tested. These impurities not only reduce the efficacy of viral vector-related drugs but may also pose safety risks such as infectivity or tumorigenicity. Therefore, regulatory authorities worldwide strictly control the content of residual DNA in biological products.

The E1A Residual DNA Fragment (qPCR) Detection Kit independently developed by Junyan Biotech uses E1A DNA quantitative reference materials to quickly and accurately quantify E1A residual DNA fragments in intermediate, semi-finished, and finished biological products. The kit has a linear range of 4×10⁶ copies/μL to 4×10⁰ copies/μL (4 copies/μL) and is used in conjunction with Junyan Biotech’s host cell residual DNA sample pretreatment kit.


Advantages and Features


  • Comprehensive Fragment Coverage:
    Detects E1A residual DNA fragments of 99 bp, 165 bp, 274 bp, and 554 bp, maximizing coverage of potential functional gene sizes to meet customer needs.

  • Wide Linear Range & High Sensitivity:

    • Linear range: 4×10⁶ copies/μL ~ 4 copies/μL

    • Sensitivity as low as 4 copies/μL, enabling precise quantification of DNA residue levels and fragment distribution.


Performance Indicators


  • Linear Range of Standard Curve: 4×10⁶ – 4 copies/μL

  • Fluorescent Group: FAM

  • Limit of Quantitation (LOQ): 4 copies/μL

  • Detection Principle: Fluorescent probe qPCR method

  • Applicable Instruments: Suitable for various domestic and imported quantitative PCR instruments

  • Accuracy: Measurement deviation < 5%




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