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Product Description
SHENTEK® Residual CHO DNA Quantitation Kit is designed for quantitation of residual Chinese Hamster Ovary (CHO) host cell DNA in a variety of biopharmaceutical products. The kit uses quantitative PCR (absolute quantitation with a standard curve) to perform rapid and specific quantitation of residual DNA at the femtogram level. For nucleic acid extraction and sample preparation guidance, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. SK030203D100). The kit is supplied as reagents for 100 reactions and is intended for research use only.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Quantitation of residual CHO host cell DNA in biopharmaceutical products (research use only). |
| Detection principle | Absolute quantitation by quantitative PCR (standard curve). |
| Quantitation range (standards) | Standard concentrations prepared from CHO DNA Control: 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. (Implied dynamic range: 300 to 0.003 pg/μL using provided standards.) |
| Limit of quantitation / sensitivity | Standards include down to 0.003 pg/μL (ST6). No explicit LOQ/LOD numeric claim provided; users should validate limit of quantitation (QL) in their own laboratory. |
| Reaction volume | 30 μL total reaction volume (20 μL qPCR MIX + 10 μL sample or standard). |
| Sample input per reaction | 10 μL purified sample (or 10 μL standard/controls as described). |
| qPCR mix provided | Ready-to-use CHO qPCR MIX supplied (mix thoroughly before use); protect from light. |
| Thermal cycling conditions | Activation: 95 °C for 10:00; 40 cycles of Denaturation 95 °C for 0:15 and Annealing/Extension 60 °C for 1:00 (fluorescence read at 60 °C). |
| Cycling count | 40 cycles |
| Acceptance criteria — ERC recovery | Recovery of Extraction Reference Control (ERC) samples should be between 50% and 150%. |
| Acceptance criteria — NTC / NCS | NTC: Ct should be Undetermined or not less than 35.00 (or laboratory-specific criteria). NCS Ct should be larger than the mean Ct of the lowest standard; if proven QL is lower than minimum standard concentration, NCS detected value should be less than QL. |
| Instrument compatibility | Compatible with common real-time PCR systems including SHENTEK-96S, ABI 7500, Bio-Rad CFX96, LineGene 9600 Plus, Mx3000P, qTOWER 3 G, StepOnePlus (consult instrument documentation for setup). |
| Kit stability | Kit components may be stored under recommended conditions for up to 24 months (check label expiration date). |
| Reactions per kit | Reagents for 100 reactions |
| Recommended analysis settings (example ABI 7500 SDS v1.4) | Manual Ct with threshold = 0.02 and Automatic Baseline; set task types for standard, unknown, NTC as described. |
Features
- High sensitivity: Capable of detecting residual CHO DNA down to femtogram-level concentrations (standards provided to 0.003 pg/μL).
- Ready-to-use qPCR mix: Provided CHO qPCR MIX formulated for absolute quantitation—minimizes preparation steps and variability.
- Complete standard curve control: Includes CHO DNA Control and DNA Dilution Buffer to prepare a 6-point standard curve for absolute quantitation.
- Broad instrument compatibility: Validated on multiple real-time PCR platforms; instrument-specific setup instructions included.
- Workflow guidance: User guide includes serial dilution protocol, plate layout examples, thermal cycling program, and acceptance criteria (ERC recovery, NTC/NCS rules).
Applications
- Quantitation of residual CHO host cell DNA in biopharmaceutical drug substance and drug product
- Quality control of biologics production (host cell DNA monitoring)
- Process development and purification monitoring for cell-derived products
- Method validation and release testing in research settings
Kit Contents
CHO DNA Control (Part No. NNA001)50 μL × 1 tube; store at –20 °C
CHO qPCR MIX (Part No. NNC001)1 mL × 2 tubes; store at –20 °C, protect from light
DNA Dilution Buffer (DDB) (Part No. NND001)1.5 mL × 3 tubes; store at –20 °C (remaining unused DDB may be stored at 2–8 °C; if cloudy, warm to 37 °C to clarify)
* Total: 100 Reactions | Method: qPCR (absolute quantitation, standard curve)
Attention
• For research use only. Not for diagnostic use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (eye protection, mask, gloves, lab coat).
• Irradiate bench, pipettes and tubes with UV for 30 minutes and disinfect with 75% ethanol before setup to avoid contamination.
• Thaw reagents at 2–8 °C or on ice, vortex and centrifuge briefly; mix CHO qPCR MIX thoroughly and protect from light.
• Follow instrument-specific setup and analysis parameters; example settings are provided for ABI 7500 SDS v1.4 but may need adjustment for other platforms.
• Store kit components at recommended temperatures; per USP <659> items with –20 °C recommendation should be stored within ±10 °C (–30 °C to –10 °C).
• Validate limit of quantitation (QL) and other performance metrics in your laboratory prior to routine testing.
• Ensure NTC (no template control) is undetermined or Ct ≥ 35 and NCS meets acceptance criteria before reporting sample 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 sensitivity of the kit and how low can it quantify CHO DNA?
The provided standard curve includes concentrations down to 0.003 pg/μL (ST6). The kit enables femtogram-level detection, but users should perform laboratory validation to determine the assay’s limit of quantitation (QL) under their specific conditions.
Q2: What is the recommended reaction setup and sample input volume?
Total reaction volume is 30 μL (20 μL CHO qPCR MIX + 10 μL sample or standard). Use 10 μL of purified test sample per reaction as described in the user guide.
Q3: How should reagents be stored and what is kit stability?
Store CHO DNA Control, CHO qPCR MIX and DNA Dilution Buffer at –20 °C (protect qPCR mix from light). Kit components are stable for up to 24 months; check expiration on labels.
Q4: What should I do if the NTC shows amplification?
If NTC (no template control) is amplified (Ct < 35 or determined), suspect contamination. Decontaminate workspace and consumables (UV, 75% ethanol), re-prepare master mixes and controls, and repeat the assay. Verify pipetting technique and use fresh aliquots of reagents.
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.
