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Product Description
SHENTEK® Residual CV-1 DNA Quantitation Kit is designed to quantitate residual CV-1 host cell DNA across stages of biopharmaceutical production, from in-process samples to final products. The kit uses quantitative PCR (qPCR) to deliver rapid, specific and reliable quantitation at the femtogram (fg) level and includes a CV-1 DNA Control reference standard. For sample extraction procedures, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended reactions | Reagents for 100 reactions |
| Standard curve concentrations | 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 |
| Lowest included standard (indicative sensitivity) | 0.003 pg/µL (3 fg/µL) — kit supports femtogram-level quantitation; validated LOQ must be determined by laboratory validation |
| qPCR reaction volume | Total reaction volume: 30 µL (20 µL qPCR mix + 10 µL sample/diluent) |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer: 17 µL; CV-1 Primer & Probe MIX: 3 µL; Total qPCR MIX per reaction: 20 µL |
| Thermal cycling conditions | Activation: 95 °C, 10:00 (1 cycle); Denaturation: 95 °C, 00:15 (40 cycles); Annealing/Extension: 60 °C, 1:00 (fluorescence read during this step) |
| Fluorescence detection settings | Recommended reporter dye: FAM; passive reference: ROX (ABI7500 example). Manual Ct threshold example: 0.02 (Automatic baseline recommended) |
| Quality acceptance criteria | ERC recovery: 50%–150%; NTC Ct should be ≥35 cycles or undetermined (or per laboratory validation); NCS Ct should be larger than mean Ct of lowest standard (or below LOQ if applicable) |
| Storage stability | Kit components stable up to 24 months at recommended storage conditions (component-specific temperatures listed in kit contents) |
Features
- High sensitivity: Claims femtogram-level detection; lowest provided standard 0.003 pg/µL (3 fg/µL) allowing very low-level residual DNA quantitation.
- qPCR-based absolute quantitation: Absolute quantitation using a supplied CV-1 DNA Control standard curve (six dilution points recommended).
- Ready-to-use mixes: Pre-formulated qPCR Reaction Buffer and Primer & Probe MIX to streamline assay setup.
- Compatibility: Compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600).
- Comprehensive workflow support: Includes guidance for standard curve preparation, plate layout recommendations, qPCR program settings and result analysis instructions.
Applications
- Quantitation of residual CV-1 host-cell DNA in biopharmaceutical in-process samples
- Quantitation of residual CV-1 host-cell DNA in final drug substance/drug product
- Method validation and assay development for host-cell DNA monitoring
- Quality control and release testing for products produced in CV-1 cells
- Process development and optimization where host-cell DNA monitoring is required
Kit Contents
CV-1 DNA Control (NNA026)-20 °C; 50 μL × 1 tube
qPCR Reaction Buffer (NNB001)-20 °C; 850 μL × 2 tubes; protect from light
CV-1 Primer & Probe MIX (NNC097)Store as labeled (provided 300 μL × 1 tube); follow kit storage instructions
DNA Dilution Buffer (DDB) (NND001)-20 °C (store unused DDB at 2–8 °C during use); 1.5 mL × 3 tubes
DocumentationUser Guide and instructions included
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for human diagnostic or therapeutic use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions.
• Use appropriate PPE: protective eyewear, mask, lab coat and gloves.
• Use DNase-free, low-retention consumables to avoid contamination.
• Decontaminate work surfaces and pipettes with UV (30 minutes) and 75% ethanol before setup.
• Thaw reagents on ice (2–8 °C), vortex and spin briefly before use; protect light-sensitive reagents.
• Prepare standard curve fresh using serial dilutions; include at least five concentrations for curve fitting.
• Seal plates with appropriate film, mix and spin briefly before placing on instrument.
• Acceptance criteria: ERC recovery 50%–150%; NTC Ct ≥35 cycles or undetermined (or per lab validation); NCS Ct must be > mean Ct of lowest standard or below validated LOQ.
• Instrument-specific program and detector settings must be configured per instrument/software documentation (ABI7500 example provided).
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 assay sensitivity or lowest detectable concentration?
The kit provides a lowest standard of 0.003 pg/µL (3 fg/µL) and is designed to support femtogram-level quantitation. The validated limit of quantitation (LOQ) should be determined by laboratory validation and may be lower or higher depending on sample matrix and extraction recovery.
Q2: How should reagents be stored and handled?
Store kit components at recommended temperatures (major components at -20 °C). Thaw reagents on ice (2–8 °C), vortex and spin briefly before use. Protect light-sensitive components (e.g., qPCR Reaction Buffer) from light. Follow MSDS guidance and use DNase-free consumables.
Q3: What acceptance criteria should I use for controls?
ERC recovery should be between 50% and 150%. NTC should have Ct ≥35 cycles or be undetermined (or per laboratory validation). The NCS Ct should be larger than the mean Ct of the lowest concentration in the standard curve or below the validated LOQ.
Q4: Which instruments are supported and what detector settings are recommended?
The kit is compatible with common real-time PCR systems (e.g., SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600). In the ABI7500 example, create a FAM detector (reporter FAM), set ROX as passive reference, use Manual Ct threshold 0.02 and Automatic baseline; thermal cycling: 95 °C activation 10:00; 40 cycles of 95 °C 00:15 and 60 °C 1:00 (read fluorescence during anneal/extension). Adjust settings per instrument and software version.
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.
