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For Research Use Only (RUO)
$3,708.00
Sku: 1103174
Product Description
SHENTEK® Residual Vero DNA Size Analysis Kit (2G) is a real-time PCR (qPCR) based assay for rapid and specific quantitation of residual Vero (host cell) DNA fragments across multiple size ranges in biopharmaceutical samples (in-process to final product). The kit is designed to amplify four discrete fragment lengths (85 bp, 134 bp, 229 bp and 552 bp) and determine size distribution and quantity down to the femtogram (fg) level. Includes primer/probe mixes for each fragment, an internal positive control (IPC), qPCR reaction buffer, DNA dilution buffer (DDB) and a Vero DNA control for generating standard curves. Reagents are provided for 4 × 100 reactions. For sample extraction and preparation refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Target fragment sizes | 85 bp, 134 bp, 229 bp, 552 bp |
| Analytical method | Real-time PCR (absolute quantitation, standard curve) |
| Reported sensitivity / limit of detection | Detects and quantifies Vero DNA down to the femtogram (fg) level (standard curve includes concentrations down to 0.03 pg/µL) |
| Standard curve concentrations (per kit dilution scheme) | ST0 (prepared) 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 |
| Reaction format & volumes | Per reaction: 20 µL qPCR MIX + 10 µL template/standard/NTC (total 30 µL reaction volume). qPCR MIX composition per reaction: qPCR Reaction Buffer 15.9 µL; Vero Primer&Probe MIX 2.8 µL; IPC MIX 1.3 µL; total qPCR MIX 20 µL. |
| Thermal cycling program | Activation 95 °C 10:00 (1 cycle); Denaturation 95 °C 00:15; Annealing 60 °C 00:30; Extension 72 °C 01:30; 40 cycles. Fluorescence read during extension step. |
| Internal control (IPC) criteria | Sample Ct(IPC) should be within ±1.0 Ct of NCS Ct(IPC). Significant increase indicates potential inhibition; evaluate recovery with ERC samples. |
| Negative control (NTC) criteria | NTC Ct should be ≥ 2 Ct higher than mean Ct of the lowest standard concentration, or laboratory-specific acceptance criteria established during validation. |
| Kit stability | Kit components can be stored under appropriate conditions for up to 24 months; check label expiration date. |
| Intended use | Quantitation and size-distribution analysis of residual Vero DNA in biopharmaceutical samples (research use only). |
Features
- Multi-fragment size analysis: Four specific primer/probe assays amplify 85 bp, 134 bp, 229 bp and 552 bp fragments to determine size distribution of residual DNA.
- High sensitivity: Designed to quantify residual DNA at femtogram-level sensitivity using absolute quantitation and serial standard curves.
- Built-in internal control: IPC mix included to monitor inhibition and reaction performance for each sample.
- Ready-to-use reagents: Pre-formulated qPCR reaction buffer and primer/probe mixes minimize setup variability and speed workflow.
- Compatible with common instruments: Validated on multiple real-time PCR platforms (SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600plus) and adjustable to other qPCR instruments following instrument software guidance.
Applications
- Quantitation of residual Vero (host cell) DNA in biopharmaceutical process samples
- Assessment of DNA fragment size distribution during downstream processing and in final product
- In-process testing and release testing in research and development (RUO) workflows
- Method validation and recovery studies for host cell DNA assays
Kit Contents
qPCR Reaction Buffer (NNB001) 850 µL × 8 tubes-20 °C, protect from light
Vero Primer & Probe MIX-85 (NNC020) 300 µL × 1 tubeStore per label (typically -20 °C)
Vero Primer & Probe MIX-134 (NNC021) 300 µL × 1 tubeStore per label (typically -20 °C)
Vero Primer & Probe MIX-229 (NNC022) 300 µL × 1 tubeStore per label (typically -20 °C)
Vero Primer & Probe MIX-552 (NNC023) 300 µL × 1 tubeStore per label (typically -20 °C)
IPC MIX (NNC069) 550 µL × 1 tubeStore per label (typically -20 °C)
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C (unused DDB may be stored at 2–8 °C per instructions)
Vero DNA Control (NNA010) 50 µL × 1 tubeStore per label (typically -20 °C)
Provided documentationRoom temperature
* Total: Reagents for 4 × 100 reactions (400 reactions total) | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic use.
• Read MSDS and user guide before use.
• Wear appropriate PPE (gloves, eyewear, mask, lab coat).
• Prevent nucleic acid contamination: UV-decontaminate workspace, use DNase-free consumables, aliquot reagents and change tips between samples.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge before use.
• Store reagents as labeled; check expiration date on labels.
• Follow instrument-specific settings and analysis parameters; adjust thresholds/baselines per instrument/software.
• Include appropriate controls: standards (ST1–ST5), NTC, NCS and IPC for each run.
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 analytical sensitivity (limit of detection) of the kit?
The assay is designed for femtogram-level sensitivity. The supplied standard curve includes concentrations down to 0.03 pg/µL (ST5). Exact LOD/LOQ should be established during laboratory validation.
Q2: Which instruments are compatible with this kit?
The kit has been used with SHENTEK-96S, ABI 7500 (with ROX), Bio-Rad CFX96 and LineGene 9600plus. Other real-time PCR instruments are supported; follow instrument-specific setup and dye assignments.
Q3: How are results interpreted and what are acceptance criteria for controls?
Set up an absolute quantitation standard curve (ST1–ST5). IPC Ct for samples should be within ±1.0 of the NCS IPC Ct; significant deviation indicates inhibition. NTC Ct should be at least 2 Ct higher than the mean Ct of the lowest standard (or per laboratory acceptance criteria).
Q4: How should I prepare the standard curve?
Thaw Vero DNA Control and DDB on ice. Prepare ST0 at 3000 pg/µL using DDB, then perform serial 1:10 dilutions to obtain ST1=300 pg/µL, ST2=30 pg/µL, ST3=3 pg/µL, ST4=0.3 pg/µL and ST5=0.03 pg/µL. Include at least five standard points (suggested ST1–ST5) in triplicate.
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.
