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For Research Use Only (RUO)
Product Description
The SHENTEK® PCV-1 Analysis Kit is a real-time PCR based qualitative assay serving as an analytical quality control reagent engineered exclusively for the molecular evaluation of bioprocessing inputs, such as in vitro cell culture supplements and cell banks. Optimized for compatibility with the SHENTEK® Nucleic Acid Extraction Kit (Product No. 1506730), this assay ensures the efficient recovery and analysis of target nucleic acids from complex industrial matrices.
Technical Specifications
| Parameter | Details |
|---|---|
| Intended use | Qualitative detection of Porcine Circovirus Type 2 (PCV-2) contamination in cell banks, cell culture, trypsin and serum (research use only). |
| Kit size | Reagents for 50 reactions (Product No. 1506745). |
| Limit of detection (LOD) | 50 copies per reaction. |
| Detection chemistry / format | Probe-based real-time quantitative PCR (qPCR), dual-channel reporting (FAM for PCV-2 target, VIC for internal control). |
| Reaction setup (per well) | Prepare qPCR MIX then combine 20 µL qPCR MIX + 10 µL sample (extracted nucleic acid or control) for a 30 µL final reaction volume. |
| qPCR MIX composition (per reaction) | qPCR Reaction Buffer 15.9 µL; PCV-2 Primer & Probe MIX 2.4 µL; VIR IPC MIX 1.7 µL; (if VIR Internal Control not added during extraction, add 0.5 µL VIR Internal Control to MIX). Total qPCR MIX volume: 20 µL (test samples). |
| Thermal cycling conditions | Activation: 95 °C 10:00 (mm:ss) ×1; Denaturation: 95 °C 00:15; Annealing/Extension: 60 °C 01:00; 40 cycles. Fluorescence read during annealing/extension. |
| Acceptance / result interpretation thresholds | Controls: NTC — FAM undetected; VIC Ct < 35 or undetected depending on control. Test sample positive: FAM Ct < 40 (specific amplification) and VIC Ct < 35 for duplicates. Negative: FAM undetected and Ctsample - CtNCS < 2. If Ctsample - CtNCS ≥ 2 or VIC inhibited, result not conclusive and repeat extraction or remove inhibitors. |
| Specificity | No cross-amplification observed with genomes from bovine, porcine, cell lines (CHO, Vero, 293T, MDCK, NS0, Sf9) or engineering bacteria (E. coli, Pichia pastoris). |
| Compatible instruments | SHENTEK-96S Real-time PCR System; LightCycler 480 II; ABI 7500 Real-Time PCR System; other qPCR instruments supporting probe-based assays. |
| Storage | -20 °C (components stable up to 24 months; follow label expiry and protect primer/probe mix from light). |
| Controls provided / required | No Template Control (NTC), Negative Control Sample (NCS), Positive Control Sample (PCS) recommended; VIR Internal Control provided to monitor extraction/PCR inhibition. |
| Recommended sample types | Cell culture (≤10^7 cells per 100–200 µL), bovine serum, trypsin and other biological matrices (use SHENTEK Virus DNA & RNA Extraction Kit for sample prep). |
Features
- High sensitivity: Limit of detection down to 50 copies per reaction enabling sensitive detection of PCV-2 contamination.
- High specificity: No cross-amplification reported with multiple mammalian cell lines and common engineering microbes.
- Integrated internal control: VIR Internal Control monitors extraction efficiency and PCR inhibition (VIC channel).
- Compatibility: Validated on common real-time PCR platforms (SHENTEK-96S, LightCycler 480 II, ABI 7500) and adaptable to other probe-based qPCR instruments.
- Convenient workflow: Ready-to-use primer/probe mix and supplied reaction buffer simplify setup; designed to be used with SHENTEK Virus DNA & RNA Extraction Kit for robust sample processing.
Applications
- Qualitative molecular analysis of PCV-2 target sequences in industrial cell banks
- Analytical quality control of biological seed lots
- Molecular evaluation of in vitro cell culture supplements for PCV-2 nucleic acids
- In-process monitoring and lot-release analysis for biological manufacturing
- In vitro research projects assessing PCV-2 target sequences in complex culture matrices
Kit Contents
Attention
• For research use only (RUO). Not for human or diagnostic clinical use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions; wear appropriate PPE (eyewear, mask, gloves, laboratory clothing).
• Handle positive control and extraction procedure in a biosafety cabinet; follow BSL‑2 laboratory safety guidelines.
• Use nuclease-free consumables and reagents. Avoid cross-contamination between samples, controls and reagents.
• Thaw kit components at 2–8 °C or on ice; vortex and centrifuge briefly before use.
• If VIC internal control signal is inhibited, repeat sample preparation or remove inhibitors and re-run the assay.
• Store kit components according to label and check expiration date; items recommended at ≤ -20 °C should be stored within ±10 °C (–30 °C to –10 °C) per USP guidance.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
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.

