Residual CHO DNA Size Analysis Kit (2G) SHENTEK®

For Research Use Only (RUO)

$3,708.00

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Sku: 1103170-2
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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 Size Analysis Kit (2G) is a fluorescent quantitative PCR (FAM) based kit for rapid and specific quantitation of residual Chinese Hamster Ovary (CHO) host cell DNA fragments across multiple size ranges in biopharmaceutical samples (from in-process to final products). The assay amplifies four discrete fragment sizes (95 bp, 110 bp, 215 bp and 523 bp) to produce an accurate size distribution profile. The kit includes primer/probe mixes for each fragment, an internal positive control (IPC), qPCR reaction buffer, CHO DNA control for standard curves and DNA dilution buffer (DDB). The assay sensitivity reaches femtogram (fg) level. Refer to SHENTEK® Residual Host Cell DNA Sample Preparation Kit (Product No. 1104191) for extraction procedures. Product No.: 1103170-2. Reagents sufficient for 4 × 100 reactions.

Technical Specifications

Parameter Details
Target fragment sizes 95 bp, 110 bp, 215 bp, 523 bp
Detection chemistry / dyes Target probes: FAM reporter; IPC: VIC reporter; ROX as passive reference
Sensitivity (LOD) Detection limit reaches femtogram (fg) level
Standard curve concentrations (examples) ST1 = 300 pg/µL; ST2 = 30 pg/µL; ST3 = 3 pg/µL; ST4 = 0.3 pg/µL; ST5 = 0.03 pg/µL (ST0 = 3000 pg/µL stock)
Suggested linear range Approximately 0.03 – 300 pg/µL (based on provided standard curve points)
Reaction volume 30 µL total reaction volume (20 µL qPCR MIX + 10 µL sample/standard)
qPCR mix per reaction qPCR Reaction Buffer 15.9 µL + CHO Primer&Probe MIX (per fragment) 2.8 µL + IPC MIX 1.3 µL = 20 µL
Sample input per reaction 10 µL (standard/ST1–ST5, DDB for NCS, or purified sample)
Thermal cycling conditions Activation: 95 °C 10:00 (1 cycle); Denaturation: 95 °C 00:15; Annealing: 60 °C 00:30; Extension/Read: 72 °C 01:30; 40 cycles. Fluorescence read during extension step.
Analysis settings (recommended) Manual Ct selection; Threshold = 0.02; Automatic baseline; Standard curve (Absolute Quantitation)
Assay throughput Reagents provided for 4 × 100 reactions (kit components support ~400 reactions distributed across four fragment assays)

Features

  • Multi-size profiling: Simultaneous measurement strategy (four separate assays) for size distribution of CHO residual DNA (95, 110, 215, 523 bp) to characterize fragmentation.
  • High sensitivity: Detection limit at femtogram (fg) level enables quantitation of very low-level residual host cell DNA.
  • Ready-to-use mixes: Pre-formulated CHO Primer & Probe MIXes and qPCR Reaction Buffer simplify setup and reduce pipetting variability.
  • Internal positive control (IPC): IPC mix included (VIC-labeled) to monitor inhibition and reaction performance.
  • Instrument compatibility: Validated on common real-time PCR systems (e.g., SHENTEK-96S, ABI 7500, Bio-Rad CFX96, Linegene 9600 plus).
  • Complete workflow support: Includes DNA control and DNA dilution buffer for standard curves plus protocol for plate layouts and analysis.

Applications

  • Quantitation of residual CHO host cell DNA in biopharmaceutical in-process samples
  • Quantitation and size-distribution analysis of residual CHO DNA in final drug substance/product
  • Method development and validation for host cell DNA monitoring
  • Routine QC testing of downstream purification and final product release (research and development settings)

Kit Contents

qPCR Reaction Buffer (NNB002)–20 °C, protect from light (850 μL × 8 tubes)
CHO Primer&Probe MIX-95 (NNC087)–20 °C (300 μL × 1 tube)
CHO Primer&Probe MIX-110 (NNC088)–20 °C (300 μL × 1 tube)
CHO Primer&Probe MIX-215 (NNC089)–20 °C (300 μL × 1 tube)
CHO Primer&Probe MIX-523 (NNC090)–20 °C (300 μL × 1 tube)
IPC MIX (NNC069)–20 °C (550 μL × 1 tube)
CHO DNA Control (NNA001)–20 °C (50 μL × 1 tube)
DNA Dilution Buffer (DDB) (NND001)2–8 °C recommended after thaw; (1.5 mL × 3 tubes)
* Total: 4 × 100 Reactions | Method: qPCR (Fluorescent quantitative PCR, FAM)

Attention

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

• Read Material Safety Data Sheets (MSDS) and follow handling instructions.

• Wear appropriate PPE (protective eyewear, mask, lab coat, gloves).

• Work in DNase-free environment; use DNase-free consumables and low-retention tips to avoid contamination.

• Irradiate workspace, pipettes and tubes with UV for 30 minutes and disinfect with 75% alcohol before use.

• Thaw reagents completely at 2–8 °C or on ice; protect light-sensitive reagents from light.

• Store kit components at –20 °C and check expiration dates. Kit stable up to 24 months under recommended storage.

• Prepare separate standard curves for each fragment length (95, 110, 215, 523 bp). Include at least five standard concentrations.

• If DNA Dilution Buffer (DDB) is cloudy or contains precipitates, heat at 37 °C until clear before use.

• Use NTC (no template control), NCS (negative control sample) and ERC (extraction reference control) as directed to monitor contamination and extraction recovery.

• Mix qPCR reactions thoroughly, seal plate, spin briefly and avoid bubble formation prior to run.

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 assay sensitivity (limit of detection)?
The kit sensitivity reaches the femtogram (fg) level. Standard curve points provided include concentrations down to 0.03 pg/µL (30 fg/µL) and a stock at 3000 pg/µL; actual LOD may depend on instrument and sample matrix.
Q2: Which real-time PCR instruments are compatible?
The kit has been used with SHENTEK-96S, ABI 7500, Bio-Rad CFX96 and Linegene 9600 plus. Other instruments supporting FAM/VIC detection and ROX (if needed) may be used — consult instrument documentation for detector/dye settings.
Q3: How should the kit be stored and what is its shelf life?
Store kit components at –20 °C, protect light-sensitive reagents from light. Under recommended storage the kit is stable for up to 24 months; always verify the expiration date on labels.
Q4: How many reactions does the kit support and how are reactions prepared?
The kit provides reagents for 4 × 100 reactions. Typical reaction setup is 20 µL qPCR MIX + 10 µL sample = 30 µL total. Prepare separate qPCR mixes for each fragment assay (95/110/215/523) as described in the protocol.

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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