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Product Description
SHENTEK® Residual MDCK DNA Quantitation Kit is designed to quantitate residual MDCK host cell DNA in biopharmaceutical workflows, from in‑process samples to final products. The kit uses quantitative PCR (qPCR) for rapid, specific and reliable absolute quantitation at the femtogram (fg) level. The kit includes a MDCK DNA control, primer & probe mix, reaction buffer and DNA dilution buffer. For nucleic acid extraction guidance, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191).
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use / Application | Quantitation of residual MDCK host cell DNA in biopharmaceutical samples (in‑process and final product) |
| Detection method | Quantitative PCR (qPCR), absolute quantitation using standard curve |
| Sensitivity / LOD | Claims detection at femtogram (fg) level; lowest provided standard concentration = 0.003 pg/μL (3 fg/μL) |
| Standard curve / Linear range (provided) | Standard concentrations prepared: 3000, 300, 30, 3, 0.3, 0.03, 0.003 pg/μL (ST0–ST6); at least five concentrations recommended for standard curve |
| Limit of Quantitation (LOQ) | LOQ not explicitly specified; protocol notes use of validated LOQ; if LOQ < lowest standard, NCS value should be less than LOQ |
| Reaction volume | Total qPCR reaction volume = 30 μL (20 μL qPCR mix + 10 μL sample/standard) |
| qPCR mix composition (per reaction) | qPCR Reaction Buffer 17 μL + MDCK Primer & Probe MIX 3 μL = 20 μL qPCR MIX per reaction |
| Thermal cycling | Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 0:15 (40 cycles); Annealing/Extension: 60 °C 1:00 (read fluorescence during this step) |
| Instrument compatibility | Compatible with common real‑time PCR instruments (SHENTEK‑96S, ABI 7500, Bio‑Rad CFX96, StepOne Plus, LineGene 9600, Mx3000P, etc.) |
| Controls and acceptance criteria | NTC Ct should be ≥ 35 cycles or undetermined; Negative Control Sample (NCS) Ct should be larger than mean Ct of lowest standard (or less than LOQ if validated LOQ is lower); ERC recovery acceptance: 50%–150% |
| Total reactions per kit | Reagents for 100 reactions (as labeled Product No.: SK030209M100) |
| Storage stability | Kit components storable under appropriate conditions up to 24 months; individual components stored at -20 °C |
| Assay readout / analysis settings (example) | Recommended analysis: Manual Ct, threshold for MDCK‑DNA = 0.02, automatic baseline; set tasks (Standard, Unknown, NTC) and verify slope, intercept, R² for standard curve |
Features
- High sensitivity: Detects residual MDCK DNA down to the femtogram level (lowest provided standard 0.003 pg/μL = 3 fg/μL).
- Absolute quantitation: Standard‑curve based absolute quantitation using supplied MDCK DNA control and serial dilutions.
- Ready-to-use primer/probe mix: Includes validated MDCK Primer & Probe MIX to simplify assay setup and improve reproducibility.
- Broad instrument compatibility: Validated for use on multiple common real‑time PCR platforms (ABI 7500, CFX96, StepOne Plus, LineGene, Mx3000P, SHENTEK‑96S, etc.).
- Kit format: Provides reagents for 100 reactions with pre‑measured components (control, buffer, primer/probe mix and dilution buffer).
Applications
- Quantitation of residual MDCK host cell DNA in biopharmaceutical process development
- In‑process monitoring of host cell DNA levels
- Release testing support for final biopharmaceutical products (research use)
- Method validation and assay development for MDCK host cell DNA detection
Kit Contents
MDCK DNA Control (NNA006) — 50 μL × 1 tube-20 °C
qPCR Reaction Buffer (NNB001) — 850 μL × 2 tubes-20 °C, protect from light
MDCK Primer & Probe MIX (NNC024) — 300 μL × 1 tube-20 °C
DNA Dilution Buffer (DDB) (NND001) — 1.5 mL × 3 tubes-20 °C
* Total: 100 reactions | Method: qPCR (absolute quantitation using standard curve)
Attention
• For research use only (not for diagnostic or therapeutic use).
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (eyewear, mask, lab coat, gloves).
• Use DNase‑free, low‑retention consumables; decontaminate workspace and pipettes with UV (30 min) and 75% ethanol before setup.
• Thaw reagents at 2–8 °C or on ice, vortex and spin briefly; store unused DNA Dilution Buffer at 2–8 °C.
• Protect light‑sensitive reagents (qPCR Reaction Buffer) from light.
• Include appropriate controls: NTC, NCS, ERC and standard curve in each run.
• Seal plates properly, mix and centrifuge briefly before placing on instrument.
• Follow instrument/software‑specific parameter settings; example settings provided for ABI 7500 with SDS v1.4.
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 standard concentration provided and what is the claimed sensitivity?
The provided serial dilution scheme includes standards down to 0.003 pg/μL (3 fg/μL). The kit is intended to enable quantitation at the femtogram level.
Q2: What is the recommended reaction setup and total reaction volume?
Prepare a 20 μL qPCR mix per reaction (17 μL qPCR Reaction Buffer + 3 μL Primer & Probe MIX) and add 10 μL sample/standard for a total reaction volume of 30 μL.
Q3: What are the qPCR cycling conditions?
Example program: Activation 95 °C 10:00 (1 cycle); Denaturation 95 °C 0:15 (40 cycles); Annealing/extension 60 °C 1:00 with fluorescence read during this step.
Q4: What acceptance criteria should be used for controls?
NTC Ct should be ≥ 35 cycles or undetermined; NCS Ct should be larger than the mean Ct of the lowest standard (or below validated LOQ if applicable); 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.
