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Product Details
Product Overview
This kit is based on TaqMan probe‑based real‑time quantitative PCR technology, specifically designed for the qualitative and quantitative detection of Minute Virus of Mice (MVM) during biopharmaceutical manufacturing. It can be used for MVM contamination screening and viral clearance validation in cell culture supernatants, recombinant proteins / antibodies, viral vectors, cell therapy products (e.g., CAR‑T), vaccines, and animal‑derived raw materials. The kit employs specific primers and probes targeting highly conserved regions of the MVM genome, covering four major strains: i, p, m, and c. It features high sensitivity, high specificity, and strong anti‑interference capacity. An Internal Control (IC) is included to monitor nucleic acid extraction and amplification efficiency throughout the assay, effectively preventing false‑negative results.
Features
- High specificity: Primers and probes target highly conserved regions of the MVM genome, covering four major strains (i, p, m, c), with no cross-reactivity with common engineering cells (CHO, Vero, HEK293/293T, etc.) and engineering bacteria.
- Built-in Internal Control (IC): Monitors the entire process of nucleic acid extraction and PCR amplification, effectively preventing false-negative results.
- Strong anti-interference capacity: Optimized reaction system resists matrix interference from complex biopharmaceutical samples, ensuring stable detection performance.
- Wide sample adaptability: Suitable for cell culture supernatants, recombinant proteins/antibodies, viral vectors, CAR-T products, vaccines, and animal-derived raw materials.
- Mainstream instrument compatibility: Agilent and other common real-time quantitative PCR instruments.
- Regulatory compliance: The detection method meets the requirements of ICH Q2(R2) and relevant pharmacopoeia standards, supporting method validation and regulatory submission.
- Efficient workflow: The entire detection process (including nucleic acid extraction) can be completed in about 3 hours, improving laboratory testing efficiency.
Application
The kit is used for detection of Minute Virus of Mice (MVM) contamination in biological product, cells and bioproduct media etc.
For use in quality control/manufacturing process only.
It is for research use only.
Technical Specifications
Attention
If your experimental workflow involves host cell DNA sample preparation, please use the recommended sample preparation kits listed in the table. This ensures that the buffers used during both sample preparation and residual DNA quantitation remain consistent, supporting reliable and accurate results.
Materials Provided
IDComponentsSizeOPA-S104-01MVM qPCR Master Mix750 μL×2OPA-S104-02MVM Assay Mix400 μLOPA-S104-03MVM Positive Control1 mLOPA-S104-04MVM Internal Control1 mLOPA-S104-05DNase/RNase-Free Water1.5 mL×3ACRO Quality Management System
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Performance Data
Typical Data
Please refer to DS document for the assay protocol.
Figure 1. LOD: 1 copy/μL=10 copies/Reaction
Figure 2. MVM genomic DNA was 10-fold serially diluted from 1 copy/μL to 1×10⁵ copies/μL. Amplification curves showed uniform intervals and consistent performance across all gradients, with an LOD of 1 copy/μL (10 copies per reaction).
Figure 3. At high, medium, and low MVM gDNA concentrations, no cross interference or cross reactivity was detected with DNA from common cell lines (CHO, HEK293, Vero) or non target microbes (Mycoplasma, E. coli, Pichia pastoris).
Figure 4. Covers four MVM strains (m, I, c, and p) (1 copies/μL)
Figure 5. Compatible matrices include Metrix, DMEM, FBS, DFG, CHO cells (10⁶/mL), AM103, and AM103+5% FBS. No significant interference with MVM detection was observed, and performance met specifications.
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