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Product Description
The SHENTEK® Vesivirus 2117 Detection Kit is a qualitative RT‑qPCR assay for detection of Vesivirus 2117 contamination in mammalian cell lines (e.g., CHO) and related sample matrices used in biopharmaceutical production. The kit is designed to be used together with the SHENTEK® Virus DNA & RNA Extraction Kit (Product No. 1506730). The assay includes a Vesivirus 2117 Positive Control and a VIR Internal Control (IC) to monitor extraction and amplification. The method achieves a sensitivity of 50 copies per reaction, demonstrates high specificity without cross‑amplification of a range of cell line and microbial genomes, and is suitable for detecting viral RNA from complex matrices such as cells and serum. For Research Use Only.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Qualitative detection of Vesivirus 2117 RNA in mammalian cell lines and related samples (e.g., cell culture, bovine serum). |
| Limit of Detection (LOD) | Sensitivity of 50 copies per reaction (reported assay sensitivity). |
| Specificity | High specificity; no cross‑amplification observed with genomes from CHO, VERO, 293T, MDCK, NS0, Sf9, E. coli, Pichia pastoris and other tested bovine/porcine/engineering cell lines. |
| Sample types | Cell culture (≤10^7 cells), bovine serum, and other matrices amenable to SHENTEK® Virus DNA & RNA Extraction Kit. |
| Reaction format / volume | 20 µL total reaction volume (10 µL RT‑qPCR MIX + 10 µL sample/controls); per reaction RT‑qPCR MIX composition provided (10 µL final MIX). |
| RT‑qPCR mix composition (per reaction) | 5×RT‑qPCR Buffer 4 µL, RT‑qPCR Enzyme MIX 1 µL, VV‑2117 Primer&Probe MIX 3.3 µL, VIR IPC MIX 1.7 µL, (optionally) VIR Internal Control (IC) 0.5 µL; final volume 10 µL RT‑qPCR MIX. |
| Thermal cycling conditions | Reverse transcription 50 °C for 15:00 (1 cycle); Activation 95 °C for 0:30 (1 cycle); 40 cycles of 95 °C for 0:15 and 60 °C for 1:00 (fluorescence read during 60 °C). |
| Acceptance / interpretation thresholds | Control acceptance: FAM and VIC Ct < 35.0 for PCS; NTC and NCS: undetected in FAM and Ct < 35.0 in VIC. Test sample calls: FAM Ct < 40.0 (at least one replicate) with specific amplification = Positive. Negative defined as undetected FAM and VIC sample Ct difference to NCS (Ctsample − CtNCS) < 2. If Ctsample − CtNCS ≥ 2, result is not conclusive (possible inhibition). |
| Controls included / recommended | Vesivirus 2117 Positive Control (PCS) — separate product (1506743‑R01) recommended; VIR Internal Control (IC) and VIR IPC MIX included to monitor extraction/amplification. No Template Control (NTC) and Negative Control Sample (NCS) required. |
| Total reactions per kit | Reagents for 50 reactions. |
| Shelf life | Kit components can be stored under appropriate conditions for up to 24 months; check expiration on labels. |
| Recommended instruments | Compatible with SHENTEK‑96S, LightCycler 480Ⅱ, ABI 7500 and other real‑time PCR systems supporting probe assays (FAM/VIC detection). |
| Extraction | Designed to be used with SHENTEK® Virus DNA & RNA Extraction Kit (Product No. 1506730); automated extraction on rHCDpurify system recommended but manual extraction possible per extraction kit guide. |
Features
- High sensitivity: Assay sensitivity reported at 50 copies per reaction for reliable detection of low‑level contamination.
- High specificity: No cross‑amplification with a panel of mammalian cell lines and common engineering microorganisms tested.
- Internal/extraction controls: Includes VIR Internal Control (IC) and VIR IPC MIX to monitor extraction efficiency and PCR inhibition; Positive Control provided as separate product.
- Compatibility: Validated on SHENTEK‑96S, LightCycler 480Ⅱ and ABI 7500; general probe‑based qPCR instruments supported.
- Optimized for complex matrices: Combined workflow with SHENTEK extraction kit enables efficient recovery of viral RNA from cells and serum.
Applications
- Screening for Vesivirus 2117 contamination in mammalian cell substrates (e.g., CHO) used in biopharmaceutical manufacturing
- Quality control and viral adventitious agent testing of cell culture and bovine serum
- Laboratory surveillance and investigation of suspected Vesivirus 2117 contamination
- Research studies requiring qualitative detection of Vesivirus 2117 RNA
Kit Contents
VIR Internal Control (IC) (NNA057) 600 µL × 1 tubeStore at -20 °C (check label)
5×RT‑qPCR Buffer (NNB018) 300 µL × 1 tubeStore at -20 °C
RNase‑Free H2O (NND008) 1.2 mL × 1 tubeStore at -20 °C (or as labelled)
RT‑qPCR Enzyme MIX (NNC079) 100 µL × 1 tubeStore at -20 °C, protect from light
VV‑2117 Primer & Probe MIX (NNC123) 170 µL × 1 tubeStore at -20 °C (check label)
VIR IPC MIX (NNC107) 100 µL × 1 tubeStore at -20 °C (check label)
* Total: 50 reactions | Method: RT-qPCR
Attention
• For Research Use Only (not for diagnostic or therapeutic use).
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate protective eyewear, gloves, mask and lab clothing.
• Handle positive control and extraction steps in a biosafety cabinet and follow BSL‑2 laboratory safety guidelines.
• Use nuclease‑free consumables; avoid RNase/DNase contamination.
• Thaw kit reagents completely at 2–8 °C or on ice, vortex and briefly centrifuge before use.
• Protect enzyme mixes from light; store components at recommended temperatures and check expiration dates on labels.
• Include NTC, NCS and PCS controls and run duplicates as recommended; follow acceptance criteria for Ct interpretation.
• If inhibition is suspected (VIC Ct difference ≥ 2 vs NCS), retest after removing inhibitors or repeat extraction.
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 limit of detection (LOD) for this kit?
The assay sensitivity is reported at 50 copies per reaction.
Q2: Which sample types are supported?
The kit is validated for mammalian cell culture samples (e.g., CHO cells, ≤10^7 cells) and bovine serum when used with the SHENTEK® Virus DNA & RNA Extraction Kit; other complex matrices may be used following appropriate extraction and validation.
Q3: How do I interpret Ct values?
A sample is positive when FAM Ct < 40.0 (at least one replicate) with specific amplification. PCS, NCS and NTC acceptance criteria and VIC internal control thresholds are provided in the user guide; if the VIC Ct difference indicates inhibition (Ctsample − CtNCS ≥ 2), the result is not conclusive and re‑extraction or inhibitor removal is recommended.
Q4: How should the kit be stored and what is its shelf life?
Store kit components at −20 °C as indicated on labels. Components are stable for up to 24 months under appropriate storage conditions; always check the expiration date on tube labels.
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.
