For collection of whole blood samples and stabilization of circulating cell-free (ccfDNA) from plasma and gDNA from the nucleated cellular fraction

• CE Marked for In Vitro Diagnostic (IVD) use*
• Single tube collection, stabilization, transport and storage
• Formaldehyde-free, non-crosslinking stabilization of circulating, cell-free DNA (ccfDNA)
• Stabilization of ccfDNA in plasma and genomic DNA (gDNA) in the nuclear cellular fraction for days at various temperatures facilitates transport and storage
• Standardized preanalytical processing of samples
• Barcode with tube ID, lot number and expiration date and unique serial number
• The PAXgene Blood ccfDNA Tube (CE-IVD) with the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and QIAGEN QIAsymphony instrument (CE-IVD) have been validated as an integrated workflow

* According to EU Regulations on in vitro diagnostic medical devices (REGULATION (EU) 2017/746).

For automated purification of circulating, cell free DNA (ccfDNA) from plasma generated from whole blood collected into PAXgene Blood ccfDNA Tubes (CE-IVD) using the QIAGEN QIAsymphony SP instrument

• CE Marked for In Vitro Diagnostic (IVD) use*
• Optimized binding chemistry and input volumes for PAXgene Blood ccfDNA Tubes (CE-IVD)
• Prefilled reagent cartridges with bar code for safety and ease of use
• Standardized processing for high reproducibility
• Primary tube handling protocols allow centrifuged PAXgene Blood ccfDNA Tubes (CE-IVD) to be placed directly on the QIAGEN QIAsymphony SP instrument
• The PAXgene Blood ccfDNA Tube (CE-IVD) with the QIAsymphony PAXgene Blood ccfDNA Kit (CE-IVD) and QIAGEN QIAsymphony instrument (CE-IVD) have been validated as an integrated workflow

* According to EU Regulations on in vitro diagnostic medical devices (REGULATION (EU) 2017/746).

PreAnalytiX recommends the use of BD Vacutainer safety-engineered sample collection products for use with the PAXgene Blood ccfDNA Tube. These products are designed to provide high quality samples and to protect healthcare workers from accidental needlestick injuries.

Backed by customer support and training, BD Vacutainer products increase everyday lab productivity by minimizing recollects, retests, and instrument downtime.