Residual Vero DNA Quantitation Kit SHENTEK™

For Research Use Only (RUO)

$1,545.00

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Sku: SK030204V100
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⚡ Detection Method
qPCR
🕒 Assay Time
Less than 3 hours
🎯 Storage Temperature
–20 °C (stable for 12 months)

Product Description

The SHENTEK™ qPCR-based Residual Vero DNA Quantitation Kit is a high sensitivity, probe-based quantitative PCR assay designed for accurate detection and quantitation of residual Vero host cell DNA in biopharmaceutical products. This kit enables rapid and reliable measurement at femtogram (fg) levels, supporting QC workflows from in-process intermediates to final product testing. Compatible with standard research qPCR platforms, the kit delivers precise DNA monitoring required for host DNA clearance validation and regulatory-aligned quality control.

Technical Specifications

Parameter Details
Linear Range 3×10⁻³ – 3×10² pg/µL (R²=0.99942, E=93.5%)
Accuracy (Recovery) 70.4% – 94.1% (CV < 30%)
LOD / LOQ LOD: 0.0005 pg/µL | LOQ: 0.03 pg/µL
Precision 6.2% – 17.5% (Standard: < 30%)
Robustness Freeze-thaw stability > 5 cycles
Instrument Compatibility Thermo, Bio-Rad, SHENTEK, and other major platforms
Compliance Research Use Only (RUO)

Features

  • High Sensitivity: Reliable quantitation at femtogram levels.
  • Wide Dynamic Range: Accurate over 5 logs of DNA concentration.
  • Probe-based Specificity: High target specificity with probe-based qPCR.
  • Robust Performance: Optimized for stability in complex biological matrices.

Applications

  • In-process intermediates and purified drug substances.
  • Final product formulations and biologics.
  • Vaccine, mAb, and viral vector quality control (Vero line).

Kit Contents

Vero DNA Control-20℃
qPCR Reaction Buffer-20℃, Dark
Vero Primer & Probe MIX-20℃, Dark
DNA Dilution Buffer (DDB)-20℃
* Total: 100 Reactions | Method: Probe-based qPCR

Attention

• Strictly for RUO: Not for clinical diagnostic use.

• Storage: Keep at –20 °C. Protect Buffer/Mix from light.

• Validation: High robustness validated for 5 freeze-thaw cycles.

Quality Management & Certifications

Quality System

Download QMS

QMS (ISO, GMP)

Download Certificate

Quality Advantages

View Report

Quality Control Process

Download Process

📂 Technical Resources & Downloads

Frequently Asked Questions (FAQ)

Q1: What detection method is used in this kit?
This kit is based on a probe-based quantitative PCR (qPCR) method, enabling highly sensitive and specific quantitation of residual Vero host cell DNA in biopharmaceutical samples.
Q2: What types of samples can be tested with this kit?
The kit is suitable for a wide range of bioprocess-related samples, including: In-process intermediates, Purified drug substances, and Final product formulations.
Q3: What is the sensitivity of the Residual Vero DNA Quantitation Kit?
This qPCR assay offers femtogram-level sensitivity, with a low limit of detection (LOD) and reliable quantitation across a wide linear dynamic range.
Q4: Is this product intended for clinical or diagnostic use?
No. This product is intended for Research Use Only (RUO) and is not for use in diagnostic or therapeutic procedures.

Research Use Only

✔

For Research Use Only (RUO) – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.

✔

Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.

Copyright © 2026 Biofargo. All Rights Reserved. | Disclaimer: For Research Use Only. Not for use in diagnostic procedures.

When can I expect my order to ship?

Most orders are filled and shipped within 2-3 business days from the time they are received.

Our standard shipping usually take 2-5 days.

We also provide express shippping for time-sensitive deliveries. 

Email contact@biofargo.com if you have any requirements.

 

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