Replication-Competent Lentivirus (RCL) Quantitation Kit SHENTEK®

For Research Use Only (RUO)

$1,751.00

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Sku: 1403441
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⚡ Detection Method
qRT-PCR
🕒 Assay Time
Refer to manual
🎯 Storage Temperature
-20 °C (stable for 24 months)

Product Description

SHENTEK® Replication-Competent Lentivirus (RCL) Quantitation Kit is used for the quantitative detection of replicable lentiviral RCL in cell therapy products and gene therapy products produced with lentiviral vectors, such as virus-producing cell banks, end of production cells, viral vectors and CAR-T cells. This kit is rapid, specific and reliable, and can work in coordination with the SHENTEK® Virus DNA & RNA Extraction Kit to quantitate the copy number of replicable lentivirus RCL in samples.

Technical Specifications

Parameter Details
Intended use Quantitative detection of replication-competent lentivirus (RCL) in cell therapy and gene therapy products (virus-producing cell banks, end-of-production cells, viral vectors, CAR-T cells).
Assay format One-step reverse transcription quantitative PCR (qRT-PCR) with FAM-labeled probe; ROX passive reference recommended.
Provided standard curve range (recommended) Standard dilutions ST2–ST6: 6 × 10^5, 6 × 10^4, 6 × 10^3, 6 × 10^2, 6 × 10^1 copies/µL (prepared from ST = 6 × 10^8 copies/µL).
Recommended reaction volumes qRT-PCR MIX per reaction 10 µL; add 20 µL sample/standard/NTC for a total reaction volume of 30 µL.
qRT-PCR master mix composition (per reaction) 5×RT-qPCR Buffer 6 µL; RT-qPCR Enzyme MIX 1 µL; RCL Primer&Probe MIX 3 µL; total 10 µL.
Thermal cycling program Reverse transcription: 50 °C 15:00 (1 cycle); Activation: 95 °C 0:30 (1 cycle); 40 cycles: 95 °C 0:15 (denature), 60 °C 1:00 (anneal/extend, fluorescence read).
Instrument compatibility Compatible with common real-time PCR systems (SHENTEK-96S, Applied Biosystems 7500, LightCycler 480 II, CFX96, qTOWER3 G, etc.).
Detection/read settings Reporter dye: FAM; Passive reference: ROX; Threshold setting example: 0.02 (manual Ct), automatic baseline.
Acceptance criteria (controls) NTC Ct should be >= 35.00 cycles. NCS Ct should be larger than the mean Ct of the lowest concentration in the standard curve.
Kit shelf life Kit components can be stored at -20 °C; stable for up to 24 months (check label expiration date).
Sensitivity / dynamic range (inferred from standard curve) Demonstrated standard curve points cover at least 6 × 10^5 to 6 × 10^1 copies/µL (user should perform validation to determine empirical LOD/LOQ).
Replicates recommended Triplicate wells recommended for each standard, control and test sample.
Sample input 20 µL purified sample per 30 µL reaction (per example workflow); samples must be processed/extracted (e.g., with SHENTEK Virus DNA & RNA Extraction Kit) prior to qRT-PCR.

Features

  • Rapid and specific quantitation: One-step qRT-PCR assay optimized for accurate quantitation of replication-competent lentivirus (RCL).
  • Compatibility: Works with common real-time PCR instruments and is compatible with SHENTEK® Virus DNA & RNA Extraction Kit for upstream sample prep.
  • Ready-to-use reagents: Includes primer & probe mix, buffer and enzyme mixes; standardized control for construction of a quantitative standard curve.
  • High throughput: Reagents provided for up to 100 reactions and plate-based workflows (96-well format) supported.
  • Established QC criteria: Includes recommended control acceptance criteria (NTC and NCS Ct thresholds) and example standard curve settings for result interpretation.

Applications

  • Quantitation of replication-competent lentivirus (RCL) in virus-producing cell banks
  • Testing end-of-production cells for RCL contamination
  • Quantitation of RCL in viral vector preparations
  • Safety testing of CAR-T cells and other lentiviral-transduced cell therapy products
  • Process development and release testing workflows for gene and cell therapy manufacturing (research use)

Kit Contents

RCL Control (Part No. NNA044), lyophilized powder × 1 tube-20 °C
RCL Primer&Probe MIX (Part No. NNC077), 300 µL × 1 tube-20 °C, protect from light
5×RT-qPCR Buffer (Part No. NNC078), 600 µL × 1 tube-20 °C
RT-qPCR Enzyme MIX (Part No. NNC079), 100 µL × 1 tube-20 °C, protect from light
RNase-Free H2O (Part No. NND008), 1.2 mL × 3 tubes-20 °C
ddH2O (Part No. NND010), 1 mL × 1 tube-20 °C
* Total: 100 reactions | Method: qRT-PCR

Attention

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

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

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

• Protect light-sensitive reagents from light; store all components at -20 °C.

• Prevent RNase contamination: use RNase-free consumables and work areas; thaw reagents at 2–8 °C or on ice.

• UV-decontaminate benches, micropipettes and tubes for 30 minutes and disinfect with 75% ethanol before use.

• Process Negative Control Sample (NCS) through the same extraction and handling steps as test samples.

• Include at least five standard curve points (ST2–ST6) and run samples in triplicate for reliable quantitation.

• Verify instrument-specific parameter settings; follow instrument documentation when adapting program parameters.

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 intended use of this kit?
This kit is intended for research use to quantitatively detect replication-competent lentivirus (RCL) in cell therapy and gene therapy related samples (e.g., virus-producing cell banks, end-of-production cells, viral vectors, CAR-T cells).
Q2: What detection instrument and dye settings should I use?
The assay is compatible with common real-time PCR systems (e.g., SHENTEK-96S, ABI 7500, LightCycler 480 II, CFX96). Use FAM as the reporter dye and ROX as the passive reference (if applicable).
Q3: What are the recommended reaction and cycling conditions?
Prepare a 30 µL reaction (10 µL qRT-PCR MIX + 20 µL sample). Thermal program: 50 °C 15:00 (RT), 95 °C 0:30 (activation), then 40 cycles of 95 °C 0:15 and 60 °C 1:00 (fluorescence read).
Q4: How should I prepare the standard curve and what is the dynamic range?
Dissolve the supplied RCL control and perform serial 10-fold dilutions to generate ST2–ST6. Recommended standard concentrations span 6 × 10^5 to 6 × 10^1 copies/µL; include at least five points for the standard curve and run in triplicate.

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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