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Product Description
SHENTEK® Residual Human DNA Quantitation Kit (2G) is a duplex quantitative PCR (qPCR) kit for quantitation of residual human host-cell DNA in biopharmaceutical samples from in-process to final products. The assay achieves femtogram-level sensitivity and includes an Internal Positive Control (IPC) in the Human Primer & Probe MIX to monitor PCR performance. The kit contains a Human DNA Control for standard curve generation and ready-to-use qPCR Master MIX and Primer&Probe MIX. Intended for research use only.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual human host-cell DNA in biopharmaceutical samples (in-process to final products) |
| Assay format | Duplex quantitative PCR (qPCR) with Human-DNA detector (FAM) and IPC (VIC) |
| Sensitivity | Quantitation at femtogram (fg) level; NTC detection value acceptance ≤ 6.00 fg/μL (user may set criteria by method validation) |
| Standard curve concentrations (example) | ST1 = 300 pg/μL; ST2 = 30 pg/μL; ST3 = 3 pg/μL; ST4 = 0.3 pg/μL; ST5 = 0.03 pg/μL |
| Typical linear range (based on standards) | 300 pg/μL to 0.03 pg/μL (example standard series provided) |
| Reaction volume | 30 μL total reaction volume (20 μL qPCR MIX + 10 μL sample/standard) |
| qPCR cycling conditions | Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 0:15; Annealing/Extension: 60 °C 1:00; 40 cycles; fluorescence read during annealing/extension |
| Analysis thresholds (example) | Manual Ct thresholds: Human-DNA = 0.05; IPC = 0.1; Automatic baseline |
| Control acceptance criteria | ERC recovery rate 50%–150%; NCS Ct should be larger than mean Ct of lowest standard and show IPC amplification; NTC detection ≤ 6.00 fg/μL and IPC amplification normal |
| Pack size / yield | Reagents for 100 reactions (product no. 1101108) |
| Storage stability | Kit components can be stored at appropriate conditions for up to 24 months (see component labels) |
Features
- High sensitivity: Quantitation at femtogram (fg) level
- Duplex assay with IPC: Includes Internal Positive Control in the Primer&Probe MIX to monitor PCR performance and detect inhibition
- Ready-to-use mixes: Supplied qPCR Master MIX and Primer&Probe MIX reduce setup time and variability
- Broad instrument compatibility: Validated on multiple real-time PCR systems (SHENTEK-96S, ABI 7500, CFX96, LightCycler 480)
- Workflow convenience: Includes Human DNA Control and DNA Dilution Buffer with recommended serial dilution scheme for standard curve generation
Applications
- Quantitation of residual human host-cell DNA in biopharmaceutical products (in-process and final product)
- Process monitoring and release testing
- Method validation and assay development for residual host DNA
- Comparative testing of extraction methods (use with Extraction Reference Control, ERC)
Kit Contents
Human DNA Control (NNA003) 50 μL × 1 tube-20 °C
qPCR Master MIX (NNB023) 850 μL × 2 tubes-20 °C, protect from light
Human Primer & Probe MIX (includes IPC) (NNC130) 500 μL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C
Reagents for 100 reactions (kit pack information)-20 °C (components stable up to 24 months)
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic use.
• Read Material Safety Data Sheets (MSDS) and wear appropriate PPE (eyewear, mask, clothing, gloves).
• Use DNase-free, low-retention consumables; avoid contamination. UV decontaminate work surfaces and pipettes prior to setup.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge before use.
• Protect qPCR Master MIX from light.
• Include appropriate controls: NTC, NCS, and ERC. Run standards (at least five concentrations) to build a standard curve.
• Acceptance criteria: ERC recovery 50%–150%; NTC ≤ 6.00 fg/μL (or criteria defined during method validation); NCS Ct larger than mean Ct of lowest standard and shows IPC amplification.
• qPCR analysis parameters (e.g., thresholds, baseline) should be configured for the specific instrument and software version.
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 lowest concentration this kit can reliably detect?
The kit is designed for femtogram-level quantitation. Example standard points include down to 0.03 pg/μL (30 fg/μL). The kit documentation states NTC detection acceptance ≤ 6.00 fg/μL; true LOD/LOQ should be determined by the user's method validation.
Q2: Which instruments are compatible with this kit?
The kit has been used with SHENTEK-96S, ABI 7500, Bio-Rad CFX96 and Roche LightCycler 480. It is compatible with other real-time PCR instruments that support dual-channel detection (FAM and VIC), but instrument-specific setup is required.
Q3: How many reactions are included and how should reagents be stored?
The kit provides reagents for 100 reactions. Store components at -20 °C and protect the qPCR Master MIX from light. Components are stable up to 24 months—confirm expiration on labels.
Q4: What controls should I run and what are acceptance criteria?
Run a standard curve (minimum five points), Non-Template Control (NTC), Negative Control Sample (NCS), and Extraction Reference Control (ERC). ERC recovery should be between 50% and 150%. NTC detection should be ≤ 6.00 fg/μL (or per user validation). NCS Ct should be larger than the mean Ct of the lowest standard and show IPC amplification.
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.
