QIAcuity Cell and Gene Therapy (CGT) dPCR Assays

• A broad offering of 18 different wet-lab validated dPCR CGT assays
• Assays with different fluorophore choices allow multiplexing to sustain more information from one sample
• An easy and fast workflow comparable to qPCR

Adeno-associated virus (AAV) and lentivirus (LV) are widely used viral vectors in cell and gene therapy applications. However, the generation and purification of the viral vectors require rigorous quality control to enable safe and reliable dosing during clinical studies or patient care. The ability to accurately quantify vector titers, detect contamination and determine vector copy number (VCN) is critical for safe and effective AAV-based and LV-based cell and gene therapies. 
 
The kit works in conjunction with the QIAcuity Digital PCR System and the QIAcuity Nanoplates. 
 
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The QIAcuity Cell and Gene Therapy dPCR Assays are a broad offering of 18 different wet-lab validated dPCR CGT assays that come in multiple fluorophores, enabling superior accuracy, reproducibility and a dynamic range of at least four orders of magnitude with speed in measuring viral titers in a multiplex setup. The assays work in conjunction with the QIAcuity Digital PCR System, dedicated QIAcuity MasterMixes and QIAcuity Nanoplates, offering an end-to-end dPCR workflow comparable to qPCR but delivering an absolute quantification of vector genome copies or vector copy numbers in your sample. The assays have been designed with the requirements of biopharma manufacturing and QC in mind. 

The principle of the dPCR reaction in the nanoplates is described here.

Dedicated CGT assays enable viral vector quantification, such as AAV and LV, on the QIAcuity. These assays are validated and can be used in singleplex and multiplex reactions and can be additionally combined with gene-of-interest assays, delivering: 

• Accurate quantification down to 0.3 copies/µL
• High precision over a broad dynamic range
• High accuracy across assays (independent of fluorophores) and operators
• High precision (<10% deviation from the mean) independent of fluorophores and operators
• Compatibility with both dPCR and qPCR readout

The QIAcuity Cell and Gene Therapy dPCR Assays are provided in a 20x ready-to-use primer-probe mix, available in multiple fluorophore choices, and optimized for use with dedicated QIAcuity MasterMixes. These assays enable both singleplex and multiplex CGT applications, including absolute quantification of vector titer and assay robustness. 

The QIAcuity Cell and Gene Therapy (CGT) dPCR Assays, together with the QIAcuity Nanoplates and the QIAcuity PCR kits, enable digital PCR applications, including:  

• Viral vector titer 
• Viral vector genome integrity 
• Vector copy number (VCN) 
• Residual plasmid (if using Amp plasmids for the production of AAVs) 

Incorporating these CGT dPCR Assays into the quality control process of cell and gene therapy development means greater certainty in producing safe and potent treatments.