Residual CHO DNA Quantitation Kit (2G) SHENTEK™

For Research Use Only (RUO)

$1,545.00

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Sku: 1101100-1
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⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual CHO DNA Quantitation Kit (2G) is intended to quantitate host-cell line residual DNA from CHO cell lines used in biopharmaceutical production. The kit uses duplex real-time PCR (qPCR) technology to perform rapid, specific and reliable quantitation down to the fg level. An Internal Positive Control (IPC) is included in the CHO Primer & Probe MIX to evaluate PCR performance. The kit provides ready-to-use qPCR Master Mix, CHO Primer & Probe MIX with IPC, a quantified CHO DNA Control for standard curve generation, and DNA Dilution Buffer. For DNA extraction instructions, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191). Product No.: 1101100-1. Reagents for 100 reactions. For Research Use Only (RUO).

Technical Specifications

Parameter Details
Intended use Quantitation of residual CHO host-cell DNA in CHO-derived biopharmaceutical samples (research use only).
Provided reactions Reagents for 100 reactions (label on kit: Reagents for 100 Reactions).
Standard curve concentrations (serial dilutions) ST0 3000 pg/μL (stock), 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.
Analytical range (based on standards) 3000 pg/μL to 0.003 pg/μL (nominal dynamic range as provided by standard series).
Reported sensitivity / LOD (document statement) Claims quantitation at the fg level; lowest provided standard is 0.003 pg/μL (3 fg/μL).
Reaction setup (per well) 20 μL qPCR MIX (15 μL qPCR Master MIX + 5 μL CHO Primer&Probe MIX) + 10 μL sample/standard/NTC/NCS = 30 μL final reaction volume.
qPCR thermal cycling Activation 95 °C 10:00 (1 cycle); 40 cycles of 95 °C 00:15 (denaturation) and 60 °C 01:00 (anneal/extension, fluorescence read).
Detection channels and dyes CHO-DNA detector: FAM reporter; IPC detector: VIC reporter; Passive reference: ROX.
Analysis settings / thresholds Manual Ct selected. Threshold: CHO-DNA = 0.05, IPC = 0.1. Automatic baseline recommended. Instrument-specific settings may vary.
Acceptability criteria NTC Ct should be ≥ 35.00 (or laboratory-specific threshold). NCS Ct should be larger than mean Ct of lowest standard and show normal VIC amplification. ERC recovery should be between 50% and 150%.
Kit components storage conditions All listed components stored at -20 °C; protect light where indicated. Kit stable up to 24 months (check label expiration).
Product number / version / manufacturer Product No.: 1101100-1. User Guide Version: A/1. Effective date: 01 Jul. 2024. Manufacturer: Biofargo, Inc.

Features

  • Duplex real-time PCR (qPCR): Simultaneous detection of CHO target sequence and an internal positive control (IPC) in the same reaction to monitor assay performance.
  • High sensitivity: Capable of quantitation at the femtogram level; includes a dilution series down to 0.003 pg/μL (3 fg/μL) standard.
  • Ready-to-use mixes: Supplied qPCR Master MIX and CHO Primer & Probe MIX (with IPC) minimize assay setup time and reduce variability.
  • Compatibility: Validated for common real-time PCR instruments (SHENTEK-96S, ABI 7500, Bio-Rad CFX96, Roche LightCycler 480).
  • Controls included: Includes quantified CHO DNA Control for standard curve generation, DNA Dilution Buffer (DDB), and IPC in the primer/probe mix.

Applications

  • Quantitation of residual CHO host-cell DNA in CHO-derived biopharmaceuticals
  • In-process testing and process development for biologics produced in CHO cells (research use)
  • Method validation and assay development for host cell DNA monitoring
  • Quality control assays in research settings where CHO DNA detection is required

Kit Contents

CHO DNA Control-20 °C (50 μL × 1 tube)
qPCR Master MIX-20 °C, protect from light (850 μL × 2 tubes)
DNA Dilution Buffer (DDB)-20 °C (1.5 mL × 3 tubes)
CHO Primer & Probe MIX (including IPC)-20 °C, protect from light (500 μL × 1 tube)
* Total: 100 Reactions | Method: qPCR (duplex real-time PCR)

Attention

• For Research Use Only (RUO). Not for diagnostic use.

• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (gloves, eyewear, mask, lab coat).

• Prevent contamination: irradiate surfaces, 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 centrifuge before use.

• Store kit components at -20 °C and protect light-sensitive reagents from light.

• Prepare at least five standard curve points; perform method validation to select appropriate sample dilutions.

• NTC Ct acceptance: ≥ 35.00 (or lab-specific threshold). NCS Ct should be greater than mean Ct of lowest standard and display normal VIC amplification.

• ERC (extraction reference control) recovery must be between 50% and 150%.

Quality Management & Certifications

Quality System

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QMS (ISO, GMP)

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Quality Advantages

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Quality Control Process

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📂 Technical Resources & Downloads

PDF Product Manual ↓ PDF MSDS / SDS ↓

Frequently Asked Questions (FAQ)

Q1: What is the minimum detectable concentration with this kit?
The kit is designed for quantitation at the femtogram level. The lowest supplied standard is 0.003 pg/μL (3 fg/μL); actual limit of detection should be confirmed by laboratory validation.
Q2: What is the recommended reaction setup and total reaction volume?
Prepare 20 μL qPCR MIX per reaction (15 μL qPCR Master MIX + 5 μL CHO Primer & Probe MIX) and add 10 μL sample or standard for a total reaction volume of 30 μL.
Q3: Which fluorescence channels are used for target and control?
CHO target is detected in the FAM channel; the internal positive control (IPC) is detected in the VIC channel; ROX is used as passive reference when applicable.
Q4: What are the acceptance criteria for controls?
NTC Ct should be ≥ 35.00 (or a lab-defined threshold). NCS Ct should be higher than the mean Ct of the lowest standard and show VIC amplification. ERC recovery should fall 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.

 

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