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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 1 (PCV-1) contamination in cell banks, cell culture, trypsin and related biological matrices |
| Limit of Detection (LOD) | 50 copies per reaction |
| Reaction format / total volume | 30 µL reaction volume per well (20 µL qPCR MIX + 10 µL sample/DDB/controls) |
| qPCR MIX composition (per reaction) | qPCR Master MIX 15.9 µL; PCV-1 Primer & Probe MIX 2.4 µL; VIR IPC MIX 1.7 µL; (add VIR Internal Control 0.5 µL to qPCR MIX if not added during extraction) — total qPCR MIX = 20 µL |
| Thermal cycling conditions | Activation 95 °C 10:00 (mm:ss) ×1; Denaturation 95 °C 00:15; Annealing/Extension 60 °C 01:00; 40 cycles (instrument reads fluorescence during annealing/extension) |
| Acceptance criteria — controls (Ct thresholds) | NTC: FAM undetected; VIC undetected or absence of specific amplification. NCS: FAM undetected; VIC Ct < 35. PCS: FAM Ct < 35 and VIC Ct < 35 (specific amplification for duplicate runs). |
| Acceptance criteria — test samples | Positive: FAM Ct < 40 (at least one well) with specific amplification and VIC Ct < 35 for duplicates. Negative: FAM undetected and VIC present (Ctsample - CtNCS < 2). Not conclusive / inhibition: Ctsample - CtNCS ≥ 2 or inhibited VIC signal; repeat extraction and assay or remove inhibitors. |
| Specificity | No cross-amplification observed with genomes from bovine, porcine, and multiple engineered cell lines (CHO, Vero, 293T, MDCK, NS0, Sf9) or engineered bacteria/yeast (E. coli, Pichia pastoris) |
| Sample input guidance | Cell culture: collect 100–200 µL sample (≤10^7 cells) and proceed with pretreatment and extraction. Pretreatment uses Pretreatment buffer at 1:10 (sample:buffer), RT 5 min, centrifuge 450 × g 30 min at 4 °C; Proteinase K digestion: add 100 µL Proteinase K Buffer, 50 µL Proteinase K, 10 µL VIR IC; incubate 55 °C for 30 min. |
| Kit size | Reagents for 50 reactions |
| Recommended extraction | Use SHENTEK® Virus DNA & RNA Extraction Kit (Product No. 1506730); automated extraction (rHCDpurify system) recommended |
| Compatible instruments | SHENTEK-96S, LightCycler 480 II, ABI 7500 (and other real-time PCR systems supporting probe assays and FAM/VIC detection) |
Features
- High sensitivity: Limit of detection down to 50 copies per reaction enabling sensitive detection of low-level contamination.
- High specificity: Designed primers/probes show no cross-amplification with common cell lines (CHO, Vero, 293T, MDCK, NS0, Sf9) or with E. coli and Pichia pastoris genomes.
- Internal control included: VIR Internal Control monitors extraction efficiency and PCR inhibition to ensure reliable results and help identify inhibited samples.
- Optimized workflow: Pre-treatment, proteinase K digestion and recommended extraction workflow provided; compatible with automated extraction (rHCDpurify) and common qPCR instruments.
- Ready-to-use reagents: Pre-formulated primer/probe mix and qPCR Master Mix reduce setup variability and simplify assay preparation.
- Validated for complex matrices: Combined with SHENTEK extraction kit, the assay efficiently recovers PCV-1 DNA from complex matrices such as cells and serum.
Applications
- Qualitative molecular analysis of PCV-1 target sequences in industrial cell banks
- Analytical quality control of biological seed lots
- Molecular evaluation of in vitro cell culture supplements for PCV-1 nucleic acids
- In-process monitoring and lot-release analysis for biological manufacturing
- In vitro research projects assessing PCV-1 target sequences in complex culture matrices
Kit Contents
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 and gloves).
• Handle positive control and extraction procedures in a biosafety cabinet; follow BSL-2 laboratory safety guidelines.
• Use nuclease-free, RNase/DNase-free consumables and certified sterile tubes and tips.
• Thaw kit components at 2–8 °C or on ice; vortex and centrifuge briefly before use.
• Protect primer/probe mixes from light.
• Store reagents at recommended temperatures (–20 °C) and check expiration dates; kit components stable up to 24 months.
• If VIC internal control (IC) signal is inhibited, repeat sample preparation or remove inhibitors and retest.
• Follow instrument-specific settings and plate layouts; validate assay performance as required by your laboratory.
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.

