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Product Description
SHENTEK® Residual MDCK DNA Size Analysis Kit is designed to quantify fragment sizes of residual MDCK host cell DNA in biopharmaceutical samples across process stages (in‑process to final products). The kit utilizes a real‑time PCR (qPCR) approach to rapidly and specifically quantify MDCK DNA fragments using FAM‑labeled probes. It amplifies four discrete fragment lengths (84 bp, 142 bp, 204 bp and 504 bp) to determine size distribution with a limit of detection in the femtogram (fg) range. An internal positive control (IPC, VIC) is included to monitor inhibition and assay performance. For DNA extraction guidance, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191). Reagents supplied support 4 × 100 reactions.
Technical Specifications
| Parameter | Details |
|---|---|
| Target fragment sizes | 84 bp, 142 bp, 204 bp, 504 bp |
| Limit of detection (LOD) | femtogram (fg) level |
| Standard curve concentrations (example) | ST0 3000 pg/μL; ST1 300 pg/μL; ST2 30 pg/μL; ST3 3 pg/μL; ST4 0.3 pg/μL; ST5 0.03 pg/μL; ST6 0.003 pg/μL |
| qPCR reaction volume and template input | Total reaction volume 30 μL (20 μL qPCR MIX + 10 μL template/sample) |
| qPCR mix per reaction | qPCR Reaction Buffer 15.9 μL; MDCK Primer & Probe MIX 2.8 μL (per target); IPC MIX 1.3 μL; total 20 μL qPCR MIX |
| Thermal cycling conditions (example / ABI 7500 SDS v1.4) | Activation 95 °C 10:00 (1 cycle); Denaturation 95 °C 00:15; Annealing 60 °C 00:30; Extension 72 °C 01:30 (read fluorescence); 40 cycles |
| Internal control acceptance criteria | Mean Ct‑IPC of sample should be within ±1.0 of NCS Ct‑IPC. If significantly higher, sample may be inhibitory. NTC Ct should be ≥ 35 or undetermined. |
| Compatible instruments | SHENTEK‑96S, ABI 7500, LightCycler 480 II and other real‑time PCR systems |
| Kit size / total reactions | Reagents for 4 × 100 reactions (400 reactions total) |
| Storage stability | -20 °C (stable for 24 months) |
Features
- Four discrete fragment assays: Simultaneous/parallel assays for 84 bp, 142 bp, 204 bp and 504 bp fragments for size distribution profiling.
- High sensitivity: Limit of detection at the femtogram level for detection of low‑abundance residual DNA.
- qPCR based, rapid and specific: Real‑time PCR with FAM probe detection provides rapid and specific quantitation of MDCK residual DNA.
- Internal inhibition control (IPC): VIC‑labeled IPC included to monitor sample inhibition and assay performance.
- Ready‑to‑use primer/probe mixes: Preformulated MDCK Primer & Probe MIXes for each fragment length reduce setup time and variability.
- Compatible with common qPCR platforms: Validated for SHENTEK‑96S, ABI 7500, LightCycler 480 II and other real‑time PCR systems.
Applications
- Quantitation of residual MDCK host cell DNA in biopharmaceutical process intermediates and final products
- Determination of host cell DNA fragment size distribution for process development and validation
- Quality control testing for residual host cell DNA in vaccine and biologics manufacturing
- Method validation and sample inhibition assessment using IPC
Kit Contents
MDCK DNA Control (NNA006) 50 μL × 1 tube-20 °C
qPCR Reaction Buffer (NNB001) 850 μL × 8 tubes-20 °C (protect from light)
MDCK Primer & Probe MIX‑84 (NNC025) 300 μL × 1 tube-20 °C (refer to label)
MDCK Primer & Probe MIX‑142 (NNC026) 300 μL × 1 tube-20 °C (refer to label)
MDCK Primer & Probe MIX‑204 (NNC027) 300 μL × 1 tube-20 °C (refer to label)
MDCK Primer & Probe MIX‑504 (NNC028) 300 μL × 1 tube-20 °C (refer to label)
IPC MIX (NNC070) 550 μL × 1 tube-20 °C (refer to label)
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C
* Total: Reagents for 4 × 100 reactions (400 reactions) | Method: qPCR
Attention
• For Research Use Only (not for diagnostic use).
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (eyewear, mask, lab coat, gloves).
• Prevent contamination: irradiate workspace, 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 spin before use.
• Prepare separate standard curves for each fragment length (84, 142, 204, 504 bp).
• Include at least five concentrations for the standard curve and run samples in triplicate when possible.
• IPC criteria: mean Ct‑IPC of sample should be within ±1.0 of NCS Ct‑IPC; if higher, sample may be inhibitory — consider sample recovery testing.
• NTC criterion: Ct for NTC should be ≥ 35 cycles or undetermined.
• Seal plates properly, mix and spin samples before running.
• Store kit components as labeled and check expiration dates before use.
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 fragment sizes does this kit detect?
The kit contains primer/probe mixes for four fragment sizes: 84 bp, 142 bp, 204 bp and 504 bp.
Q2: What is the recommended reaction setup and volume?
Total reaction volume is 30 μL (20 μL qPCR MIX + 10 μL template/sample). Prepare qPCR MIX according to the protocol tables for each fragment assay.
Q3: How sensitive is the assay and what standards should I use?
The assay has a limit of detection at the femtogram level. Prepare the supplied MDCK DNA Control serial dilutions (examples: ST0 3000 pg/μL down to ST6 0.003 pg/μL) and include at least five standard concentrations for the standard curve.
Q4: How do I know if a sample is inhibitory?
Monitor the IPC (VIC) signal. The mean Ct‑IPC for a sample should be within ±1.0 of the NCS Ct‑IPC. A significantly higher Ct‑IPC indicates potential inhibition and you should evaluate sample recovery or dilution.
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.
