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For Research Use Only (RUO)
$1,545.00
Sku: SK030222HA100
Product Description
SHENTEK® Residual Hansenula polymorpha DNA Quantitation Kit is designed to quantitatively detect and measure residual Hansenula polymorpha host-cell DNA in biopharmaceutical samples (in-process and final products). The kit uses fluorescent quantitative PCR (real-time qPCR) with a specific primer/probe mix to provide rapid, specific and reliable quantitation at the femtogram (fg) level. The kit is supplied with DNA control material and reagents for sample dilution and qPCR reaction setup. For DNA extraction/sample preparation procedures, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191). Intended for research use only.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use / Labeling | For Research Use Only (RUO) |
| Kit format / Yield | Reagents for 100 reactions |
| 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 |
| Analytical range (implied) | 0.03 pg/µL to 300 pg/µL (30 fg/µL to 300 pg/µL) — demonstrates femtogram-level detection sensitivity |
| qPCR program | Activation 95 °C 10:00 (1 cycle); Denature 95 °C 0:15 (40 cycles); Anneal/Extend 60 °C 1:00 (read fluorescence during this step) |
| Reaction volumes | qPCR MIX per reaction: 20 µL (17 µL qPCR Reaction Buffer + 3 µL Primer&Probe MIX); Final reaction: 30 µL (add 10 µL sample or control) |
| qPCR analysis settings (recommended) | Manual Ct; Threshold = 0.02; Automatic baseline; NTC Ct ≥ 35 cycles or undetermined |
| Quality control / recovery criteria | ERC recovery acceptable range: 50%–150%; NCS Ct should be larger than mean Ct of lowest standard curve concentration (or less than LOQ if LOQ < lowest standard) |
| Storage & stability | -20 °C; kit components stable for up to 24 months (check expiration on labels) |
| Instrument compatibility | Compatible with common real-time PCR systems (SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600 plus, Mx3000P, StepOne Plus, etc.) |
Features
- High sensitivity: Detects residual Hansenula polymorpha DNA at femtogram-level sensitivity (standard curve includes down to 0.03 pg/µL).
- Fluorescent real-time qPCR: Uses a validated primer & probe mix with FAM reporter for specific and rapid quantitation.
- Complete kit for quantitation: Includes DNA control, qPCR reaction buffer, primer & probe mix and DNA dilution buffer — sufficient reagents for 100 reactions.
- Broad instrument compatibility: Protocols and settings provided for commonly used real-time PCR platforms; assay template provided for absolute quantitation (standard curve).
- QC and controls included: Guidance and materials for NTC, NCS and ERC controls; recommended acceptance criteria (NTC Ct ≥35; ERC recovery 50–150%).
Applications
- Quantitation of residual Hansenula polymorpha host-cell DNA in biopharmaceutical in-process samples
- Quantitation of residual Hansenula polymorpha DNA in final drug products
- Method validation and routine QC testing for host-cell DNA
- Research applications involving detection of Hansenula polymorpha DNA contamination
Kit Contents
Hansenula polymorpha DNA Control (NNA008)-20 °C (50 μL × 1 tube)
Hansenula polymorpha qPCR Reaction Buffer (NNB007)-20 °C (850 μL × 2 tubes) — protect from light
Hansenula polymorpha Primer & Probe MIX (NNC040)-20 °C (300 μL × 1 tube)
DNA Dilution Buffer (DDB) (NND001)-20 °C (1.5 mL × 3 tubes)
* Total: 100 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 protective eyewear, mask, lab coat and gloves.
• Decontaminate working surfaces, pipettes and tubes (UV irradiation 30 minutes recommended) and disinfect with 75% ethanol.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge to mix.
• Store kit components at -20 °C; check expiration dates.
• If DNA Dilution Buffer is cloudy, heat to 37 °C until clear before use.
• Include appropriate controls (NTC, NCS, ERC) and run samples in triplicate when possible.
• Recommended qPCR analysis settings: Manual Ct, Threshold = 0.02, Automatic baseline.
• Acceptance criteria: NTC Ct ≥ 35 cycles or undetermined; ERC recovery 50%–150%.
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 of the kit (limit of detection)?
The kit is designed for femtogram-level detection; the provided standard curve covers 0.03 pg/µL (30 fg/µL) to 300 pg/µL. Users should validate LOD/LOQ in their own laboratory and instrument setup.
Q2: What qPCR program and settings should I use?
Recommended cycling: 95 °C 10:00 (activation); 40 cycles of 95 °C 0:15 (denature) and 60 °C 1:00 (anneal/extend, read fluorescence). Analysis settings: Manual Ct, Threshold = 0.02, Automatic baseline. Adjust for your instrument if required.
Q3: How should I prepare the standard curve?
Prepare serial dilutions of the provided DNA Control in DNA Dilution Buffer to generate at least five concentrations (example: 300, 30, 3, 0.3, 0.03 pg/µL). Run each standard in triplicate for absolute quantitation.
Q4: What are acceptable QC criteria for controls?
NTC should be undetermined or Ct ≥ 35 cycles. NCS Ct should be larger than the mean Ct of the lowest standard or below the LOQ if LOQ is lower than the lowest standard. ERC recovery should be between 50% and 150%.
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.
