Residual Vero DNA-154 Quantitation Kit SHENTEK®

For Research Use Only (RUO)

$1,545.00

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Sku: SK030227V100
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⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual Vero DNA-154 Quantitation Kit is a research-use qPCR kit for quantitation of residual Vero host cell DNA in biopharmaceutical samples (in-process to final products). The kit uses a fluorescent quantitative PCR (FAM reporter) assay with a pre-formulated primer & probe mix and Vero DNA Control standard to enable rapid, specific and reliable quantitation down to the femtogram (fg) level. The kit supplies Vero DNA Control as a reference standard and DNA Dilution Buffer for standard curve preparation. For nucleic acid extraction recommendations, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191).

Technical Specifications

Parameter Details
Intended use Quantitation of residual Vero host cell DNA in biopharmaceutical samples (in-process and final products)
Assay format Fluorescent quantitative PCR (TaqMan-style probe); absolute quantitation using standard curve
Sensitivity Detectable at femtogram (fg) level (documented serial dilutions down to 0.0003 pg/μL = 0.3 fg/μL)
Standard curve concentrations Prepared from Vero DNA Control: ST0 3000 pg/μL; ST1 300 pg/μL; ST2 30 pg/μL; ST3 3 pg/μL; ST4 0.3 pg/μL; ST5 0.03 pg/μL; ST6 0.003 pg/μL; ST7 0.0003 pg/μL
Reaction volume 30 μL total reaction (20 μL qPCR MIX + 10 μL sample)
qPCR MIX composition (per reaction) qPCR Reaction Buffer 17 μL + Vero Primer & Probe MIX-154 3 μL = 20 μL qPCR MIX
Thermal cycling conditions Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 0:15 (40 cycles); Annealing/Extension: 60 °C 1:00 (read fluorescence during this step)
Reporter / Reference dyes Reporter: FAM; Passive reference: ROX
qPCR instrument compatibility SHENTEK-96S, ABI 7500, Bio-Rad CFX96, Linegene 9600plus (and similar real-time PCR systems)
Triplicates recommended Triplicate measurements recommended for standards, controls and test samples
Quality criteria / acceptance ERC recovery rate should be 50%–150%; Ct of NTC should be ≥35 or undetermined; Ct of NCS should be larger than mean Ct of lowest standard (or below validated LOQ if applicable)
Stability Kit components stable up to 24 months when stored as instructed (-20 °C)

Features

  • High sensitivity: Capable of quantitating Vero host DNA down to the femtogram level using an optimized primer/probe assay and standard curve.
  • Ready-to-use primer/probe mix: Includes pre-formulated Vero Primer & Probe MIX-154 for consistent, specific detection.
  • Supplied reference standard: Vero DNA Control provided for preparation of an 8-point serial dilution standard curve for absolute quantitation.
  • Compatible with multiple qPCR platforms: Validated workflows and example settings included for several common real-time PCR instruments.
  • User guidance for QC: Includes instructions for NTC, NCS, ERC controls and acceptance criteria (ERC recovery 50%–150%, NTC Ct ≥35).

Applications

  • Quantitation of residual Vero host cell DNA in biopharmaceutical process samples
  • Quality control testing of drug substance and drug product for residual host DNA
  • In-process monitoring of downstream purification steps
  • Method validation and assay development for residual host DNA quantitation

Kit Contents

Vero DNA Control (NNA010)-20 °C; 50 μL × 1 tube
qPCR Reaction Buffer (NNB001)-20 °C; 850 μL × 2 tubes
Vero Primer & Probe MIX-154 (NNC018)-20 °C; 300 μL × 1 tube; protect from light
DNA Dilution Buffer (DDB) (NND001)-20 °C; 1.5 mL × 3 tubes
* Total: 100 Reactions | Method: qPCR

Attention

• For Research Use Only (RUO). Not for diagnostic or therapeutic procedures.

• Read Material Safety Data Sheets (MSDS) and follow handling instructions.

• Wear appropriate PPE (protective eyewear, mask, clothing and gloves).

• Use DNase-free, low-retention consumables to avoid contamination.

• Irradiate work surfaces, pipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol before setup.

• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge before use.

• Protect primer & probe mix from light.

• Prepare standard curve with at least five concentration points and run samples in triplicate when possible.

• ERC recovery acceptance range: 50%–150%; ensure NTC Ct ≥35 or undetermined.

Quality Management & Certifications

Quality System

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QMS (ISO, GMP)

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Quality Advantages

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Quality Control Process

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📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What is the recommended reaction setup and volume?
Use a 30 μL total reaction volume (20 μL qPCR MIX + 10 μL sample). qPCR MIX per reaction is composed of 17 μL qPCR Reaction Buffer + 3 μL Vero Primer & Probe MIX-154.
Q2: What standard curve concentrations should I prepare?
Prepare serial dilutions from the provided Vero DNA Control as follows: ST0 3000 pg/μL; ST1 300 pg/μL; ST2 30 pg/μL; ST3 3 pg/μL; ST4 0.3 pg/μL; ST5 0.03 pg/μL; ST6 0.003 pg/μL; ST7 0.0003 pg/μL. Include at least five concentration points in the standard curve.
Q3: What acceptance criteria should I use for controls?
ERC recovery should be within 50%–150%. The Ct for NTC should be ≥35 or undetermined. The Ct for NCS should be greater than the mean Ct of the lowest standard (or below validated LOQ if LOQ is lower than the lowest standard).
Q4: Which instruments are compatible with this kit?
The kit is compatible with common real-time PCR platforms including SHENTEK-96S, ABI 7500, Bio-Rad CFX96, Linegene 9600plus, and similar instruments. Adjust analysis settings to your instrument/software as needed.

Research Use Only

✔

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.

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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