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For Research Use Only (RUO)
$1,545.00
Sku: 1101104-1
Product Description
SHENTEK® Residual HEK293 DNA Quantitation Kit (3G) is designed to quantify residual HEK293 host cell DNA in biopharmaceutical samples at various stages (in‑process to final product). The kit uses duplex real‑time PCR (qPCR) for rapid, specific and reliable quantitation at the fg level. An Internal Positive Control (IPC) is included in the HEK293 Primer & Probe MIX to evaluate PCR performance. The kit supports extraction workflows (refer to SHENTEK® Residual Host Cell DNA Sample Preparation Kit, Product No. 1104191) and is supplied as ready‑to‑use master mix and primer/probe reagents for up to 100 reactions.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual HEK293 host cell DNA in biopharmaceutical samples |
| Assay format | Duplex real‑time PCR (qPCR) with target (FAM) and IPC (VIC) channels |
| Kit size / Total reactions | Reagents for 100 reactions |
| Reaction volume | 20 μL qPCR MIX + 10 μL sample/control = 30 μL total reaction volume |
| Standard curve concentrations | ST1 = 300 pg/μL; ST2 = 30 pg/μL; ST3 = 3 pg/μL; ST4 = 0.3 pg/μL; ST5 = 0.03 pg/μL |
| Reported sensitivity / LOD guidance | Kit claims quantitation at the fg level. Lowest standard: 0.03 pg/μL (30 fg/μL). NTC detection value should be ≤ 6.00 fg/μL (or laboratory‑specific limit based on validation). |
| Recovery / Accuracy guidance | Extraction Reference Control (ERC) recovery rate acceptable range: 50%–150% |
| 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) |
| Analysis settings (example for ABI7500 SDS v1.4) | Manual Ct. Thresholds: HEK293‑DNA = 0.05; IPC = 0.1. Automatic baseline recommended. |
| Stability | Kit components can be stored under recommended conditions for up to 24 months; check label expiration date |
| Compatible instruments | SHENTEK-96S, ABI 7500, BioRad CFX96, Roche LightCycler 480 and other real‑time PCR systems |
Features
- High sensitivity: Claims quantitation at the femtogram (fg) level with standard curve down to 0.03 pg/μL (30 fg/μL).
- Duplex assay with IPC: Includes an Internal Positive Control (IPC) in the Primer & Probe MIX to monitor inhibition and reaction performance in each well.
- Ready‑to‑use reagents: Supplied as qPCR Master MIX and premixed Primer & Probe, minimizing setup variability.
- Wide instrument compatibility: Validated on multiple real‑time PCR platforms (e.g., SHENTEK‑96S, ABI7500, CFX96, LightCycler 480).
- Designed for biopharmaceutical testing: Optimized for residual host cell DNA measurement across in‑process and final product samples.
Applications
- Quantitation of residual HEK293 host cell DNA in upstream and downstream bioprocess samples
- Quality control testing for biologics manufacturing
- In‑process and final product residual DNA testing
- Method validation and routine monitoring of host cell DNA clearance
Kit Contents
HEK293 DNA Control-20 °C (50 μL × 1 tube)
qPCR Master MIX-20 °C, protect from light (850 μL × 2 tubes)
DNA Dilution Buffer (DDB)-20 °C (1.5 mL × 3 tubes)
HEK293 Primer & Probe MIX (Includes IPC)-20 °C, protect from light (500 μL × 1 tube)
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic or therapeutic use.
• Read Material Safety Data Sheets (MSDS) before use and follow handling instructions.
• Wear appropriate PPE (gloves, lab coat, protective eyewear, mask) and work in nuclease‑free conditions.
• Decontaminate work surfaces, pipettes and consumables by UV irradiation (30 minutes) and 75% ethanol before setup.
• Thaw reagents at 2–8 °C or on ice, vortex and briefly centrifuge. Protect light‑sensitive reagents from light.
• Unused DNA Dilution Buffer (DDB) should be stored at 2–8 °C; if cloudy, heat to 37 °C until clear.
• Perform laboratory‑specific validation to establish LOD, LOQ and acceptance criteria.
• Ensure plate layout includes appropriate standards (at least five concentrations), NTC, NCS and ERC samples; run samples in triplicate when possible.
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 claimed sensitivity of the kit and what are the lowest standard concentrations?
The kit claims quantitation at the femtogram (fg) level. The provided standard curve points include ST1 = 300 pg/μL down to ST5 = 0.03 pg/μL (30 fg/μL). Laboratories should perform validation to determine actual LOD/LOQ in their workflows.
Q2: How should I set up reaction volumes and plate layout?
Prepare 20 μL qPCR MIX per reaction and add 10 μL of sample/control to each well for a total reaction volume of 30 μL. Include at least five standard points, one NTC, one NCS and ERCs as described; triplicate wells are recommended for each sample.
Q3: What are the recommended cycling conditions and analysis settings?
Example conditions (ABI7500 SDS v1.4): Activation 95 °C for 10:00; 40 cycles of 95 °C for 00:15 and 60 °C for 1:00 with fluorescence read during the 60 °C step. Suggested thresholds: HEK293‑DNA = 0.05; IPC = 0.1; use manual Ct and automatic baseline or adapt per instrument/software.
Q4: What acceptance criteria should I use for ERC and controls?
ERC recovery should be between 50% and 150%. NTC detection value should be ≤ 6.00 fg/μL (or laboratory‑specific standard based on validation). The Ct of NCS should be larger than the mean Ct of the lowest standard and show IPC amplification in the VIC channel.
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.
