Vericheck ddPCR Replication Competent Virus Testing

Vericheck ddPCR Replication Competent Virus Testing

Replication Competent Viruses (RCVs) are virus particles that can infect cells and replicate to produce infectious viral particles. RCV testing of samples are carried out during different stages of the viral production workflow. The Vericheck ddPCR RCL (Lentivirus) and RCAAV (AAV) testing kits have been designed to run in-house ddPCR based assays for confirming the presence or absence of replication competent Lentivirus or Adeno-Associated viruses during the production of cell and gene therapy drug products.

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Overview

RCVs are virus particles that can infect cells and replicate to produce additional infectious viral particles. They can be generated through recombination events between the transfer plasmids encoding the viral genome, packaging plasmids, and the cell line used to produce the virus. This may generate wild type-like viruses that may be replication competent. RCV testing of samples is carried out during different stages of the viral production workflow.

Vericheck ddPCR RCL and RCAAV Kits provide a rapid, specific, and absolute quantification method to determine the presence of viral replication genes, potentially indicating a Replication Competent Virus (RCV). These kits significantly reduce turnaround time and cost compared to traditional methods and enhance specificity and ease of use.

Features and Benefits

  • Fast turnaround time: Results in as little as 8 hours
  • High sensitivity: LOD of 0.35 copies/µl for RCL and 0.50 copies/µl for RCAAV
  • High specificity: 99.9%
  • Novel assay design: RCAAV kit is validated to be serotype agnostic (AAV1-AAV10) and offers low CV (<10%) for reproducible results
  • Automated data analysis: Simplified workflow with positive controls included in the kit to aid automated results
  • Comprehensive ddPCR workflow: Supports and provides flexibility to run multiple samples per run
  • Validated assay protocol files (APFs): Provides qualitative reports using

Instrument Compatibility

(Bundles or different component sets) Catalog Number
QXONE Droplet Digital PCR System 12006536
QX200 AutoDG Droplet Digital PCR System consisting of:
QX200 Droplet Reader
Automated Droplet Generator
1864100
1864003
1864101
QX600 Droplet Digital PCR Reader 12013328
QX Manager Software, Regulatory Edition 12012172
QX Manager Software, Standard Edition 12012171
QX ONE Software, Regulatory Edition 12012078
QX Manager Software, Premium Edition 12018108

 

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Vericheck ddPCR RCAAV APF, QX200, APF Version 1.0
Vercheck-RCAAV-QX200

Vericheck ddPCR RCAAV APF, QX200, APF Version 1.0

Vericheck ddPCR RCAAV APF, QX600, APF Version 1.0
Vercheck-RCAAV-QX600

Vericheck ddPCR RCAAV APF, QX600, APF Version 1.0

Vericheck ddPCR RCL APF, QX200, APF Version 1.0
Vercheck-RCL-QX200

Vericheck ddPCR RCL APF, QX200, APF Version 1.0

Vericheck ddPCR RCL APF, QX600, APF Version 1.0
Vercheck-RCL-QX600

Vericheck ddPCR RCL APF, QX600, APF Version 1.0

Documents

Number Description Options
3591
Vericheck ddPCR Replication Competent Lentivirus Kit Flyer
3592
Vericheck ddPCR Replication Competent AAV Kit Flyer
10000167941
Vericheck ddPCR Replication Competent AAV Kit, User Guide
10000167942
Vericheck ddPCR Replication Competent Lentivirus Kit, User Guide