AccuPlex™ Recombinant Technology


Rapid development of molecular diagnostic molecular assays is critical to support the quick diagnosis and treatment of emerging infectious diseases. The key to the successful adoption and implementation of these assays in clinical laboratories is the availability of non-infectious, manufactured controls.

These controls should adequately represent the virus genetically and function in the appropriate assay format and sample matrix. In addition, these controls should evaluate the entire process from viral nucleic acid extraction through amplification and detection and not just a portion of the workflow (process control).

The safest, true full-process control

SeraCare’s AccuPlex™ recombinant material serves as a true molecular process control for your diagnostic assays. Compatible with multiplexed RT-PCR and NGS-based assays, AccuPlex™custom recombinant materials are constructed with a replication-deficient 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 patient samples.



Figure 1:
1) RNA sequence from the pathogenic virus of interest is chosen.
2) DNA synthesis and cloning occur 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.

AccuPlex solves development challenges

  • Non-infectious and replication deficient, enables safe and effective handling of positive material
  • Fully-extractable with a real viral protein coat; serves 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)
  • Stability studies confirm product is stable at 4 degrees C, room temperature, and elevated temperatures 


Most 'patient sample-like' material evaluates entire workflow

Unlike other technologies that package the viral RNA into a bacteriophage, the AccuPlex™recombinant closely resembles the wild-type mammalian pathogenic virus. This enables the release of the viral genome at a similar rate to the wild-type virus during the nucleic acid sample preparation process. AccuPlex™recombinant material mimics a real patient sample in your workflow, serving as a full-process control for your assay.

 





 

 

Your partner for custom recombinant controls

If you’re developing diagnostics for emerging viral diseases and have the challenge of including safe, non-infectious controls in your test kit, partner with SeraCare’s talented R&D team to produce your custom AccuPlex™ recombinant virus material (DNA or RNA-based). Utilizing your sequences of interest and product specifications, we will develop a custom solution which meets your unique requirements and development timeline.