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For Research Use Only (RUO)
$1,751.00
Sku: 1403442
Product Description
SHENTEK® Replication-Competent Retrovirus (RCR) Quantitation Kit is designed for quantitative detection of Replication-Competent Retrovirus (RCR) in cell therapy and gene therapy products produced with retrovirus vectors. The kit supports absolute quantitation using a standard-curve qRT-PCR workflow and is compatible with SHENTEK® Virus DNA & RNA Extraction Kit for upstream nucleic acid preparation. The kit provides lyophilized RCR control, primer & probe mix, qRT-PCR buffer and enzyme mix, and reagents sufficient for 100 reactions. Intended for rapid, specific and reliable monitoring of RCR in virus-producing cell banks, end-of-production cells, viral vector preparations and CAR-T cells.
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | Absolute quantitation by qRT-PCR using a standard curve |
| Recommended standard curve points | ST2–ST6 (five concentration points) corresponding to 5 × 10^5, 5 × 10^4, 5 × 10^3, 5 × 10^2, 5 × 10^1 copies/μL |
| Control stock concentration (after reconstitution) | Labelled RCR Control reconstituted to 5 × 10^8 copies/μL then serially diluted |
| Suggested quantitation range | 5 × 10^1 – 5 × 10^5 copies/μL (based on ST6–ST2 standard points) |
| Limit of detection / quantitation | Not explicitly specified in manual; lowest standard provided is 5 × 10^1 copies/μL (ST6) |
| Reaction volumes | qRT-PCR mix per well 10 μL + sample 20 μL = total 30 μL reaction volume |
| qRT-PCR component volumes (per reaction) | 5×RT-qPCR Buffer 6 μL, RT-qPCR Enzyme MIX 1 μL, RCR Primer&Probe MIX 3 μL (total 10 μL) |
| Thermal cycling program | Reverse transcription 50 °C 15:00 (1 cycle); Activation 95 °C 00:30 (1 cycle); 40 cycles of 95 °C 00:15 and 60 °C 01:00 (fluorescence read during 60 °C step) |
| Instrument compatibility | Compatible with common real-time PCR instruments (examples: SHENTEK-96S, ABI 7500, LightCycler 480 II, CFX96, qTOWER3 G); settings provided for Applied Biosystems 7500 SDS v1.4 |
| Acceptance criteria (controls) | NTC Ct should be ≥ 35.00 or undetermined. NCS Ct should be larger than mean Ct of the lowest standard concentration. |
| Kit throughput | Reagents sufficient for 100 reactions |
| Storage & stability | Store kit components at -20 °C; components stable up to 24 months (check labels for expiration) |
Features
- Designed for RCR quantitation: Specifically targets Replication-Competent Retrovirus (RCR) in cell and gene therapy products, enabling product safety testing and release control.
- Absolute quantitation: Uses a serially diluted lyophilized RCR control and a standard-curve qRT-PCR method to provide copy number (copies/μL).
- Complete qRT-PCR reagents: Includes primer & probe mix, 5× RT-qPCR buffer, RT-qPCR enzyme mix, RNase-free water and a lyophilized control; reagents provided for 100 reactions.
- Compatible with common real-time PCR platforms: Validated instructions and program settings provided for multiple instruments (e.g., ABI 7500, LightCycler 480 II, CFX96).
- RNase-free and protected formulations: RNase-free water and light-protected mixes supplied; some components labeled 'protect from light'.
Applications
- Quantitative detection of RCR in virus-producing cell banks
- Testing end-of-production cells for RCR contamination
- Quantitation of RCR in viral vector preparations
- Screening CAR‑T or other cell therapy products for RCR
- Quality control and release testing during gene/cell therapy manufacturing
- Method validation and assay development for RCR monitoring
Kit Contents
RCR Control (lyophilized powder)-20 °C
RCR Primer & Probe MIX-20 °C, protect from light
5× RT-qPCR Buffer-20 °C
RT-qPCR Enzyme MIX-20 °C, protect from light
RNase-Free H2O (1.2 mL × 3)-20 °C
ddH2O (1 mL × 1)-20 °C
* Total: 100 reactions | Method: qRT-PCR (absolute quantitation by standard curve)
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 and gloves.
• Work in RNase-free conditions; use RNase-free consumables and reagents.
• Protect light-sensitive reagents from light; store at -20 °C.
• Thaw reagents at 2–8 °C or on ice. Do not refreeze repeatedly.
• Dissolve lyophilized control by adding specified volume of ddH2O and mix thoroughly (vortex/flick and centrifuge as instructed).
• Decontaminate work surfaces and equipment (UV irradiation 30 min and 75% ethanol recommended).
• Include at least five standard curve points (recommended ST2–ST6) and appropriate controls (NTC, NCS).
• Acceptance criteria: NTC Ct ≥ 35.00 or undetermined; NCS Ct must be larger than mean Ct of lowest standard.
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 intended use of this kit?
The kit is intended for research use only to quantitatively detect Replication-Competent Retrovirus (RCR) in cell therapy and gene therapy products, including virus-producing cell banks, end-of-production cells, viral vectors and CAR‑T cells.
Q2: How many reactions does the kit support and what is the reaction setup?
The kit provides reagents for 100 reactions. Each reaction is prepared as a 30 μL total volume (10 μL qRT-PCR mix + 20 μL sample or water), with qRT-PCR mix composed of 6 μL 5×RT-qPCR Buffer, 1 μL RT-qPCR Enzyme MIX and 3 μL RCR Primer&Probe MIX per reaction.
Q3: What is the quantitation range and lowest standard provided?
The recommended standard curve uses five points (ST2–ST6) corresponding to 5 × 10^5 to 5 × 10^1 copies/μL. The lyophilized RCR Control is reconstituted to 5 × 10^8 copies/μL and serially diluted to prepare standards.
Q4: What instrument settings and acceptance criteria should I use?
Thermal program: RT 50 °C 15:00; Activation 95 °C 00:30; 40 cycles of 95 °C 00:15 and 60 °C 01:00 (read fluorescence at 60 °C). Use absolute quantitation (standard curve). NTC Ct should be ≥ 35 or undetermined; NCS Ct should be larger than mean Ct of the lowest standard.
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.
