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For Research Use Only (RUO)
$1,545.00
Sku: SK030227V100
Availability:
QUICK SHIP
In stock & estimated to ship in 1-2 days by October 06, 2026
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
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
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.
