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For Research Use Only (RUO)
$1,010.00
Sku: 1506732
Availability:
AVAILABLE
In stock & estimated to ship in 3-7 days by June 16, 2026
Product Description
The SHENTEK® PI-3 Analysis Kit is an RT-qPCR 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 |
|---|---|
| Limit of Detection (LOD) | 50 copies per reaction |
| Assay type | Qualitative RT-qPCR (probe-based) |
| Intended samples | Cell banks, virus seed banks, bovine serum (other matrices consult technical support) |
| Reaction volume | 20 μL total per reaction (10 μL RT-qPCR MIX + 10 μL extracted sample or control) |
| RT-qPCR MIX composition (per reaction) | PI-3 Primer & Probe MIX 3.7 μL; 5×RT-qPCR Buffer 4 μL; RT-qPCR Enzyme MIX 1 μL; IPC MIX 1.3 μL; total 10 μL |
| Thermal cycling conditions | Reverse transcription: 50 °C 15:00 (1 cycle); Activation: 95 °C 00:30 (1 cycle); Denaturation: 95 °C 00:15 (45 cycles); Annealing/extension: 60 °C 01:00 (45 cycles, fluorescence read during this step) |
| Ct interpretation criteria (controls) | NTC: FAM Ct ≥ 40.00 or no amplification; PCS: FAM Ct < 35.00 and VIC Ct < 35.00 for duplicate runs; NCS: FAM Ct ≥ 40.00 and VIC Ct < 35.00 for duplicate runs |
| Ct interpretation criteria (test samples) | Positive: FAM Ct < 40.00 (at least one well) with specific amplification and VIC Ct < 40.00 (duplicate runs); Presumptive positive with PCR inhibitors: FAM Ct ≥ 40.00 and VIC Ct < 40.00; Negative: FAM Ct ≥ 40.00 (no amplification) and VIC Ct < 40.00; Not conclusive if VIC inhibited (repeat extraction) |
| Compatibility (instruments) | SHENTEK-96S, LightCycler 480 II, ABI 7500, CFX96 and other real-time PCR systems supporting probe chemistry |
| Shelf life | Up to 24 months (check label expiration date) |
| Pack size / Reactions | Reagents for 50 reactions |
Features
- High sensitivity: Analytical sensitivity down to 50 copies per reaction (LOD).
- High specificity: No cross-amplification observed with bovine/porcine genomes, common engineered cell lines (CHO, Vero, 293T, MDCK, NS0, Sf9) or common production microbes (E. coli, Pichia pastoris).
- Integrated controls: Includes internal positive control (IPC) and recommended positive/negative controls to monitor extraction and amplification performance.
- Optimized master mix: Ready-to-use primer/probe mix and RT-qPCR enzyme/buffer mixes for streamlined setup and consistent performance.
- Compatible with standard workflows: Designed to be used with SHENTEK® Virus DNA & RNA Extraction Kit and compatible with common real-time PCR instruments.
- Suitable for complex matrices: Validated for detection in cell culture and bovine serum; extraction workflow recovers PI-3 RNA from complex samples.
Applications
- Qualitative molecular analysis of PI-3 target sequences in industrial cell banks
- Analytical quality control of biological seed lots
- Molecular evaluation of in vitro cell culture supplements for PI-3 nucleic acids
- In-process monitoring and lot-release analysis for biological manufacturing
- In vitro research projects assessing PI-3 target sequences in complex culture matrices
Kit Contents
PI-3 Primer & Probe MIX (NNC092)200 μL × 1 tube; –20 °C, protect from light
RT-qPCR Enzyme MIX (NNC079)100 μL × 1 tube; –20 °C
IPC MIX (NNC066)150 μL × 1 tube; –20 °C
5×RT-qPCR Buffer (NNB018)300 μL × 1 tube; –20 °C
RNase-Free H2O (NND008)1.2 mL × 1 tube; store at –20 °C or as recommended
* Total: 50 Reactions | Method: RT-qPCR
Attention
• For Research Use Only (RUO). Not for diagnostic or clinical use.
• Read Material Safety Data Sheets (MSDS) and follow handling instructions.
• Wear appropriate PPE: protective eyewear, mask, lab coat and gloves.
• Handle positive control and extraction procedures in a biosafety cabinet following BSL-2 guidelines.
• Use nuclease-free (RNase/DNase-free) consumables and reagents.
• Thaw reagents completely at 2–8 °C or on ice; vortex and spin briefly before use.
• Protect primer/probe mix from light.
• Follow SHENTEK® Virus DNA & RNA Extraction Kit user guide (Product No. 1506730) for sample preparation and extraction.
• If VIC (IPC) signal is inhibited, repeat sample preparation or remove inhibitors and repeat assay.
• Do not use beyond expiration date printed on the kit labels.
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 sensitivity (LOD) of the SHENTEK PI-3 Detection Kit?
The assay sensitivity (limit of detection) is 50 copies per reaction when used with the recommended extraction procedure.
Q2: Which sample types are supported by the kit?
The kit is validated for detection of PI-3 in cell culture samples (≤10^7 cells) and bovine serum. For other sample matrices, consult technical support.
Q3: What controls should be run with each assay?
Include a No Template Control (NTC), a Negative Control Sample (NCS), and a Positive Control Sample (PCS). Use duplicates for each control and test sample as recommended.
Q4: What should I do if the internal positive control (VIC) is inhibited?
If the VIC IPC signal is inhibited, repeat sample extraction with measures to remove inhibitors (e.g., additional purification) and retest the sample.
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.
