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Human Residual DNA Fragment (qPCR) De tection Kit
Item number：FHM0311D-4×100
Specs：4×100 R
Sell-by date：12 months
Storage conditions：-20℃
Technical support：19503412257
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Human Residual DNA Fragment (qPCR) Detection Kit

Product Introduction

Residual host cell DNA may carry tumor- or virus-related genes, posing potential risks, and drug regulatory authorities worldwide have imposed strict limits on its residual level. In May 2022, China's National Medical Products Administration (NMPA) issued the Technical Guidelines for Pharmaceutical Research and Evaluation of In-vivo Gene Therapy Products (Trial), clearly stating that "Control of residual DNA residue and fragment size is required. DNA residue should be kept below 10 ng per dose where possible, and residual DNA fragment size should be maintained under 200 bp." Pharmacopoeia of each country has also introduced several classic methods for host cell residual DNA detection, with real-time quantitative polymerase chain reaction (qPCR) currently being the optimal approach.


Series of residual DNA fragment analysis kits independently developed by Junyan Bioscitech  can rapidly and specifically detect the size distribution of residual DNA fragment from multiple host cells (Human, Hela, 293 series including HEK293, 293T, etc.). The fragment distribution intervals include: < 100 bp, 100 - 200 bp, 200 - 500 bp, and > 500 bp. This kit is used in conjunction with our host residual DNA sample pretreatment kit of our company.

Advantages and Features

  • High stability:

    It is less affected by the environment, and its performance remains stable during the shelf-life.

  • High precision:

  • Low concentration repeatability CV value < 20%

  • Medium and high concentration repeatability CV value < 15%.

  • Strong specificity:

    It is not interfered with by exogenous DNA from CHO and E. coli.

  • Fast and convenient:

    qPCR results avaliable within one hour.

Performance Indicators

  • Linear range of the standard curve: 30 fg/µL - 300 pg/µL

  • Detection principle: Fluorescent probe qPCR method

  • Limit of quantification: 30 fg/µL

  • Applicable instruments: Suitable for a variety of domestic and imported quantitative PCR instruments

  • Fluorescent group: FAM

  • Shelf - life: One year at - 20°C

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