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Product Description
SHENTEK4 Residual Bovine DNA Quantitation Kit is designed to quantitate residual bovine DNA in biomaterials using fluorescent quantitative PCR (qPCR). The assay provides rapid, specific and reliable quantitation down to the femtogram (fg) level. The kit includes bovine DNA control, primer & probe mix, internal positive control (IPC) mix, qPCR reaction buffer and DNA dilution buffer. Compatible with common real-time PCR systems (e.g., SHENTEK-96S, ABI 7500). For sample extraction recommendations refer to the SHENTEK Animal-derived Biomaterial Residual DNA Sample Preparation Kit (Product No. 1104193). For Research Use Only.
Technical Specifications
| Parameter | Details |
|---|---|
| Product Number | 1101112 |
| Kit size / Throughput | Reagents for 100 reactions |
| Analytical principle | Fluorescent quantitative PCR (absolute quantitation, standard curve) |
| Analytical sensitivity | Sensitive to femtogram (fg) level (kit description states fg-level sensitivity) |
| Standard curve / Calibration range | Prepared standards from 3000 pg/bcl down to 0.03 pg/bcl (ST1 = 3000, ST2 = 300, ST3 = 30, ST4 = 3, ST5 = 0.3, ST6 = 0.03 pg/bcl) |
| Reaction volume | 30 bL total reaction volume (20 bL qPCR MIX + 10 bL sample/standard) |
| qPCR MIX composition (per reaction) | AT qPCR Reaction Buffer 15.9 bL, Bovine primer & probe MIX 2.8 bL, IPC MIX 1.3 bL (total 20 bL); add 10 bL sample or standard |
| Thermal cycling conditions | UNG (optional) 25 b0C 10:00; Activation 95 b0C 10:00; 40 cycles of Denaturation 95 b0C 00:15 and Annealing/Extension 63 b0C 00:40 (fluorescence read during 63 b0C step) |
| Internal control acceptance criteria (IPC) | Mean Ct(IPC) of sample should be within b10.0 Ct of NCS (if significantly higher, sample inhibition suspected) |
| Extraction Recovery acceptance | ERC sample recovery rate acceptance range: 50% e2 150% |
| Negative control (NCS/NTC) criteria | Ct of NCS should be larger than mean Ct of the lowest standard; NTC Ct should be at least 2 cycles larger than mean Ct of lowest standard (or follow lab-validated criteria) |
| Recommended instruments | SHENTEK-96S Real-Time PCR System, ABI 7500 Real-Time PCR System (SDS v1.4 settings example provided) |
| Storage stability | -20 b0C, kit components can be stored at appropriate conditions for up to 24 months (check label expiry) |
| Sample input | 10 bL purified test sample or 10 bL standards/DDB per reaction (per recommended workflow) |
Features
- High sensitivity: Quantitation down to femtogram level (fg), enabling detection of trace residual bovine DNA.
- Absolute quantitation: Uses a standard-curve based absolute quantitation method with serially diluted bovine DNA controls.
- Internal process control: Includes an IPC mix to monitor PCR inhibition and validate sample results.
- Ready-to-use qPCR MIX: Pre-formulated reaction buffer and primer/probe mix minimize setup steps and reduce variability.
- Instrument compatibility: Validated for common real-time PCR platforms (example settings provided for ABI 7500 and SHENTEK-96S).
Applications
- Quantitation of residual bovine DNA in biomaterials and biological raw materials
- Quality control of biologics, bioprocess intermediates and medical device materials
- Method validation and lot release testing for products where bovine-derived contaminants must be monitored
- Research applications assessing bovine DNA contamination and extraction recovery
Kit Contents
Bovine DNA Control (NNA032) 100 bL d7 1 tube-20 b0C
Bovine Primer & Probe MIX (NNC042) 300 bL d7 1 tube-20 b0C, protect from light
AT qPCR Reaction Buffer (NNB012) 850 bL d7 2 tubesRefer to manual
IPC MIX (NNC066) 150 bL d7 1 tubeRefer to manual
DNA Dilution Buffer (DDB) (NND001) 1.5 mL d7 3 tubes-20 b0C
* Total: 100 reactions | Method: qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic or therapeutic use.
• Read Material Safety Data Sheets (MSDS) before use; wear appropriate PPE (eyewear, mask, lab coat, gloves).
• Use DNase-free, low-retention consumables; avoid contamination (UV-decontaminate surfaces and equipment, 75% ethanol disinfection).
• Thaw reagents at 2-8 b0C or on ice, vortex and briefly centrifuge before use.
• Protect primer & probe mix from light; include appropriate controls (NTC, NCS, ERC) and run at least five standard concentrations.
• If DNA Dilution Buffer becomes cloudy, warm at 37 b0C until clear; store unused DDB at 2-8 b0C.
• UNG treatment step is optional and should be included only if UNG enzyme is added to the reaction mix.
• Follow IPC and ERC acceptance criteria: IPC Ct within b11.0 of NCS; ERC recovery 50% to 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 limit of detection (LOD) or limit of quantitation (LOQ) for the kit?
The kit is designed for fg-level sensitivity. The provided standard curve ranges from 3000 pg/bcl to 0.03 pg/bcl; validated LOD/LOQ should be established by the user in their laboratory during method validation.
Q2: What qPCR instrument settings are recommended?
Example settings are provided for ABI 7500 (SDS v1.4): optional UNG 25 b0C 10:00; activation 95 b0C 10:00; 40 cycles of 95 b0C 00:15 and 63 b0C 00:40 (fluorescence read at 63 b0C). Adjust settings as needed for other platforms and software.
Q3: How should I prepare the standard curve?
Dilute the supplied Bovine DNA Control serially in DNA Dilution Buffer to generate standards: ST0 = 30000 pg/bcl (stock) then ST1 = 3000, ST2 = 300, ST3 = 30, ST4 = 3, ST5 = 0.3, ST6 = 0.03 pg/bcl. Include at least five concentrations in the curve.
Q4: What controls should be included in each run?
Include No Template Control (NTC), Negative Control Sample (NCS), Extraction Reference Control (ERC), and serial standards (ST1-ST6). Run samples and controls in triplicate when possible.
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.
