Residual E. coli DNA Quantitation Kit (2G) SHENTEK™

For Research Use Only (RUO)

$1,545.00

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Sku: 1101107-1
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⚡ Detection Method
qPCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Residual E. coli DNA Quantitation Kit (2G) is a duplex real‑time PCR (qPCR) assay designed to quantitate residual Escherichia coli host cell DNA in biopharmaceutical samples from in‑process material to final products. The kit provides high sensitivity (fg level), rapid and specific absolute quantitation using an internal positive control (IPC) included in the Primer & Probe mix to monitor PCR performance. The kit includes DNA control, qPCR master mix, DNA dilution buffer and Primer & Probe mix (with IPC). For extraction instructions, refer to the SHENTEK® Residual Host Cell DNA Sample Preparation Kit User Guide (Product No. 1104191). Supplied reagents are sufficient for 100 reactions.

Technical Specifications

Parameter Details
Intended use / application Quantitation of residual E. coli host cell DNA in biopharmaceutical samples (in‑process and final products)
Assay format Duplex real‑time PCR (absolute quantitation, standard curve)
Assay sensitivity Reported sensitivity at the fg level (document states fg level performance)
Standard curve concentrations Prepared 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
Reaction volume (program) Thermal cycling reaction volume set to 30 µL (instrument setting referenced)
qPCR thermal cycling Activation 95 °C 10:00 (1 cycle); Denaturation 95 °C 0:15, Annealing/Extension 60 °C 1:00, 40 cycles; fluorescence read during annealing/extension
Ct thresholds / analysis settings Manual Ct used. Thresholds: E.coli‑DNA = 0.05; IPC = 0.1. Automatic baseline recommended.
Acceptance criteria ERC sample recovery: 50%–150%. NTC Ct ≥ 35.00. NCS Ct should be larger than mean Ct of lowest standard and show normal VIC amplification. IPC monitored in VIC channel.
Kit size / throughput Reagents for 100 reactions
Storage stability Kit components can be stored under specified conditions for up to 24 months (check label expiration date)
Instrument compatibility SHENTEK‑96S, ABI 7500, Bio‑Rad CFX96, LightCycler 480 (and other compatible real‑time PCR systems)

Features

  • Duplex real‑time PCR: Simultaneous detection of E. coli target and IPC in the same reaction for reliable quantitation and internal reaction control.
  • High sensitivity: Designed to quantify residual E. coli DNA down to the fg level using an absolute standard curve.
  • Ready‑to‑use components: Includes DNA control, qPCR Master Mix, Primer & Probe mix (with IPC) and DNA Dilution Buffer for streamlined workflow.
  • QC acceptance criteria: Built‑in criteria for NTC, NCS and ERC recovery (50%–150%) to support routine QC and method validation.
  • Broad instrument support: Validated for common real‑time PCR instruments (ABI 7500, CFX96, LightCycler 480, SHENTEK‑96S).

Applications

  • Quantitation of residual E. coli host cell DNA in biopharmaceutical raw materials, intermediates and final products
  • Process development and in‑process monitoring
  • Quality control testing of biologics for host cell DNA
  • Method validation and CRO testing workflows

Kit Contents

E. coli DNA Control (NNA002) 50 µL × 1 tube-20 °C
qPCR Master MIX (NNB023) 850 µL × 2 tubes-20 °C, protect from light
DNA Dilution Buffer (DDB) (NND001) 1.5 mL × 3 tubes-20 °C
E. coli Primer & Probe MIX (incl. IPC) (NNC115) 500 µL × 1 tube-20 °C, protect from light
* Total: 100 Reactions | Method: qPCR

Attention

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

• Read Material Safety Data Sheets (MSDSs) before use; wear appropriate protective eyewear, mask, clothing and gloves.

• Use DNA‑free consumables; perform UV decontamination of tabletop, pipettes and tubes for 30 minutes and disinfect surfaces with 75% ethanol to minimize contamination.

• Thaw reagents on ice or at 2–8 °C, vortex and spin briefly. Protect light‑sensitive reagents (Master MIX and Primer & Probe MIX) from light.

• Store kit components at -20 °C. Unused DNA Dilution Buffer (DDB) may be stored at 2–8 °C; if cloudy, heat at 37 °C until clear.

• Include appropriate controls (standard curve, NTC, NCS, ERC) and run samples in replicates (recommended triplicates).

• Follow instrument‑specific settings when adapting the qPCR program; provided cycling parameters and analysis thresholds are validated on ABI 7500 SDS v1.4 and may need adjustment for other platforms.

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 analytical sensitivity / limit of detection (LOD) of the kit?
The user guide reports assay performance at the fg level (ultra‑sensitive); exact numeric LOD is not specified in the document and should be determined during method validation in your laboratory.
Q2: How many reactions are provided in one kit?
The kit provides reagents for 100 reactions.
Q3: How should I set up the standard curve?
Prepare serial dilutions from the supplied E. coli DNA Control to generate at least five standard points. Example dilutions in the guide: ST1 300 pg/µL, ST2 30 pg/µL, ST3 3 pg/µL, ST4 0.3 pg/µL, ST5 0.03 pg/µL. Include standards in triplicate.
Q4: What are the acceptance criteria for controls?
ERC recovery should be between 50% and 150%. NTC Ct should be ≥ 35.00. NCS Ct should be greater than the mean Ct of the lowest standard and show normal amplification in the VIC (IPC) channel.

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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