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Product Description
SHENTEK® Residual RDF21 DNA Quantitation Kit is designed for quantitation of residual RDF21 host cell DNA in biopharmaceutical samples (in-process and final products) using quantitative PCR (qPCR). The kit enables rapid, specific and reliable absolute quantitation at the femtogram (fg) level and includes an RDF21 DNA Control as the reference standard. The kit is supplied with reagents sufficient for 100 reactions and is compatible with common real-time PCR instruments (e.g., SHENTEK-96S, ABI 7500). For DNA extraction procedures, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual RDF21 host cell DNA in biopharmaceutical samples (in-process to final products). |
| Detection method | Real-time quantitative PCR (qPCR). |
| Analytical sensitivity / working sensitivity | Detectable at the femtogram (fg) level; standard curve includes concentrations down to 0.003 pg/µL (3 fg/µL). |
| Standard curve concentrations (pg/µL) | Standard points used: 300, 30, 3, 0.3, 0.03, 0.003 (ST1–ST6). |
| Reaction volume | 30 µL total reaction volume (20 µL qPCR mix + 10 µL sample/standard). |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer 17 µL + RDF21 Primer&Probe MIX 3 µL (20 µL qPCR mix); add 10 µL sample/standard/NTC to reach 30 µL). |
| Cycling conditions | Activation: 95 °C 10:00 (1 cycle); 40 cycles of 95 °C 00:15 (denaturation) and 60 °C 01:00 (anneal/extend; read fluorescence). |
| Controls and acceptance criteria | ERC recovery rate: 50%–150%. NTC Ct should be ≥35 cycles or undetermined. NCS Ct should be larger than mean Ct of the lowest standard; if validated LOQ is below lowest standard, NCS value should be below LOQ concentration. |
| Kit size / throughput | Reagents for 100 reactions (Product No.: 1101125). |
| Storage / shelf life | -20 °C storage; components stable for up to 24 months (check label expiration date). |
Features
- High sensitivity: Capable of detecting RDF21 DNA at the femtogram level (standard curve includes 0.003 pg/µL).
- Absolute quantitation: Includes RDF21 DNA Control and defined standard curve points for absolute quantitation.
- qPCR-based rapid assay: Uses real-time qPCR for fast, specific and reliable results compatible with common instruments (e.g., ABI 7500, SHENTEK-96S).
- Validated acceptance criteria: Built-in controls and acceptance criteria (ERC recovery range 50%–150%, NTC and NCS Ct requirements) to support assay QC and validation.
- Ready-to-use reagents: Pre-mixed primers/probe and reaction buffer facilitate straightforward reaction set-up and plate layout.
Applications
- Quantitation of residual RDF21 host cell DNA in biopharmaceutical process development
- Quality control testing of in-process samples and final drug substance/product
- Method validation and assay development for host cell DNA monitoring
- Routine lot release testing where host cell DNA quantitation is required (research settings)
Kit Contents
RDF21 DNA Control (NNA069)-20 °C; 50 µL × 1 tube
qPCR Reaction Buffer (NNB001)-20 °C; 850 µL × 2 tubes (protect from light)
RDF21 Primer & Probe MIX (NNC134)-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 or therapeutic use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (eyewear, mask, gloves, protective clothing).
• Irradiate work surfaces, pipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol before setup to minimize contamination.
• Thaw reagents at 2–8 °C or on ice; vortex and briefly centrifuge before use.
• Protect light-sensitive reagents (qPCR Reaction Buffer noted to protect from light).
• Store kit components at -20 °C and check expiration dates; kit stable up to 24 months.
• If DNA Dilution Buffer (DDB) is cloudy or precipitated, heat at 37 °C until clear before use.
• Include at least five concentrations in the standard curve; perform method validation to select appropriate sample dilutions.
• Acceptance criteria: ERC recovery 50%–150%; NTC Ct should be ≥35 cycles or undetermined; adjust criteria based on laboratory validation results.
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 lower standard concentration included in the kit's standard curve and what fg-level sensitivity can be expected?
The provided standard curve points include concentrations down to 0.003 pg/µL (3 fg/µL). The kit is designed to enable quantitation at the femtogram level; the practical LOQ should be determined during laboratory validation.
Q2: Which instruments are supported for this kit?
The kit has been demonstrated with SHENTEK-96S and ABI 7500 real-time PCR systems. It is compatible with other real-time PCR instruments capable of the specified cycling and fluorescence detection settings; refer to your instrument documentation for setup.
Q3: What are the recommended qPCR cycling conditions?
Activation at 95 °C for 10:00 (1 cycle), followed by 40 cycles of 95 °C for 00:15 (denaturation) and 60 °C for 01:00 (annealing/extension; read fluorescence). Total reaction volume = 30 µL.
Q4: What acceptance criteria should be used for controls?
ERC recovery should fall between 50% and 150%. NTC should have a Ct ≥35 cycles or be undetermined. NCS Ct should be larger than the mean Ct of the lowest standard; if validated LOQ is below the lowest standard, the NCS value should be below LOQ. Laboratories should set final acceptance criteria during method validation.
Research Use Only
✔
For Research Use Only (RUO). Products are intended for research use only. – 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.
