AccuPlex™ Recombinant Virus Technology
The key to successful development, validation, and implementation of molecular diagnostic assays is the availability of abundant, non-infectious, and manufactured reference materials.
These reference materials should adequately represent the target viral genome and function in the appropriate assay format and sample matrix as applicable for a typical clinical sample. For maximum effectiveness, these reference materials should evaluate the assay’s entire workflow from nucleic acid extraction through amplification and detection.
The safest, true full-process control
Compatible with multiplexed RT-PCR and NGS-based assays, AccuPlex custom recombinant virus materials are constructed with a replication-defective mammalian virus, producing a safe, non-infectious material (Figure 1). With a protein coat and lipid bilayer, these mammalian virus-based reference materials resemble the complexity of virus targets found in clinical samples.
1) RNA sequence from the pathogenic virus of interest is chosen.
2) DNA synthesis and cloning is performed to produce the recombinant RNA.
3) Recombinant RNA and helper RNA are co-transfected into the mammalian cells, allowing the encapsulation of recombined RNA.
4) Exocytosis of the mature enveloped RNA virus with the RNA sequence of the virus of interest occurs.
AccuPlex solves development challenges
- Non-infectious and replication-defective for safe and effective handling of positive material
- Fully-extractable with a real viral protein coat to serve as a full-process control
- Accepts multiple sequences from same or different RNA viruses, customizable to your sequences of interest
- Digital PCR (ddPCR) QC step allows for a wide range of titer levels, offers flexible concentrations
- Compatible with any sample matrix (e.g. DBS, buffer, serum, semen)
- Stability studies confirm product is stable at 4°C, room temperature, and elevated temperatures
Patient sample-like material evaluates entire workflow
Unlike other technologies that package the viral RNA into a bacteriophage, the AccuPlex recombinant virus releases the viral genome at a similar rate as that of wild-type mammalian pathogenic virus during the nucleic acid sample preparation step. AccuPlex recombinant virus material mimics a real clinical sample across the entire workflow, serving as a “full-process” control.
Your partner for custom recombinant controls
If you’re challenged with finding safe, non-infectious controls for your emerging viral disease assay, partner with SeraCare for custom AccuPlex recombinant virus material (DNA or RNA-based). Utilizing your target sequence of interest and product specifications, we will develop a custom solution to accelerate your development and implementation timelines.