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For Research Use Only (RUO)
$3,708.00
Sku: 1103173
Product Description
SHENTEK® Residual Human DNA Size Analysis Kit (2G) is designed for the rapid and specific quantitation of residual human DNA fragments of different sizes in biopharmaceutical samples (from in‑process to final products) using real‑time PCR (qPCR). The assay amplifies four distinct fragment lengths (75 bp, 122 bp, 244 bp and 562 bp) to determine size distribution and quantity down to the femtogram (fg) level. The kit includes primer & probe mixes for each fragment, an internal positive control (IPC), qPCR Reaction Buffer, DNA dilution buffer and a Human DNA Control for standard curve generation. For DNA extraction recommendations, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191). This product is intended for Research Use Only (RUO).
Technical Specifications
| Parameter | Details |
|---|---|
| Fragment lengths amplified | 75 bp, 122 bp, 244 bp, 562 bp |
| Quantitation sensitivity | Designed to quantitate at femtogram (fg) level; standard curve down to 0.03 pg/µL (30 fg/µL) |
| 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 |
| Reaction setup (mix + template) | qPCR mix per reaction = 20 µL (15.9 µL qPCR Reaction Buffer + 2.8 µL Primer&Probe Mix + 1.3 µL IPC MIX) + 10 µL template = 30 µL total reaction volume |
| qPCR thermal cycling | 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. |
| Ct threshold guidance | Manual Ct thresholds: Human-75 = 0.04; Human-122/244/562 = 0.02. IPC Ct of sample should be within ±1.0 of NCS. |
| Total reactions per kit | Reagents for 4 × 100 reactions (400 reactions) |
| Kit stability | Kit components stable up to 24 months (check label expiration dates) |
| Compatible instruments | SHENTEK-96S, ABI 7500, Bio-Rad CFX96, FQD-96A and other real-time PCR systems |
Features
- Multiplex fragment analysis: Assays four discrete human DNA fragment sizes (75, 122, 244 and 562 bp) to determine size distribution of residual DNA.
- High sensitivity: Quantitation down to femtogram range with standard curve points to 0.03 pg/µL.
- Ready-to-use mixes: Supplied primer & probe mixes for each fragment and IPC MIX to simplify assay setup.
- QC-focused workflow: Includes Human DNA Control for standard curves, NTC and NCS recommendations, and IPC monitoring for inhibition/recovery.
- Broad instrument compatibility: Validated on common real-time PCR platforms and configurable for different software/instruments.
Applications
- Quantitation of residual human DNA in biopharmaceutical products (in-process to final product)
- Host cell / residual DNA monitoring for process development and quality control
- Method validation and release testing workflows for biologics
- Comparative fragment size distribution analysis of residual DNA
Kit Contents
qPCR Reaction Buffer (NNB001)-20 °C, protect from light
Human Primer&Probe MIX-75 (NNC008) 300 µL ×1-20 °C
Human Primer&Probe MIX-122 (NNC009) 300 µL ×1-20 °C
Human Primer&Probe MIX-244 (NNC010) 300 µL ×1-20 °C
Human Primer&Probe MIX-562 (NNC011) 300 µL ×1-20 °C
IPC MIX (NNC069) 550 µL ×1-20 °C
Human DNA Control (NNA003) 50 µL ×1-20 °C
DNA Dilution Buffer (DDB) (NND001) 1.5 mL ×32–8 °C
* Total: 4 × 100 reactions (400 reactions) | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions.
• Wear appropriate PPE (protective eyewear, mask, lab coat, gloves).
• Irradiate bench, pipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol prior to setup.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge to mix.
• Protect light-sensitive reagents (qPCR Reaction Buffer) from light.
• Prepare separate standard curves for each fragment length (75, 122, 244, 562 bp).
• Include at least five standard points, NTC and NCS; run samples in triplicate when possible.
• IPC Ct of sample should be within ±1.0 of NCS; significantly higher IPC Ct suggests assay inhibition.
• NTC and NCS Ct values should be larger than mean Ct of the lowest standard concentration in the FAM channel.
• Configure analysis parameters and thresholds according to instrument model 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: How should I store the kit and reagents?
Store primer/probe mixes, IPC MIX, Human DNA Control and qPCR Reaction Buffer at -20 °C. Store DNA Dilution Buffer (DDB) at 2–8 °C. The kit components are stable up to 24 months; verify expiration dates on labels.
Q2: What standard curve should I use for quantitation?
Prepare a 5‑point standard curve for each fragment using the provided Human DNA Control serial dilutions: 300, 30, 3, 0.3 and 0.03 pg/µL (ST1–ST5). Include NTC and NCS controls and run standards in triplicate.
Q3: What are the recommended qPCR cycling conditions and reaction volume?
Use a 30 µL reaction (20 µL qPCR mix + 10 µL template). Thermal cycling: 95 °C 10:00 (activation); 40 cycles of 95 °C 00:15, 60 °C 00:30, 72 °C 01:30 with fluorescence read during extension.
Q4: What should I do if the IPC Ct indicates inhibition?
If IPC Ct for a sample is significantly higher than the NCS (outside ±1.0), suspect inhibition. Consider re‑extracting or diluting the sample, check sample recovery (if ERC included), and reassess prior to reporting.
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.
