Preanalytix, a Qiagen/BD Company, has received marketing clearance from the US Food and Drug Administration (FDA) for the automation of the Paxgene Blood RNA system on the Qiacube.
This clearance enables laboratories to automate an IVD purification method, which is part of an integrated IVD blood collection method for intracellular RNA.
The Paxgene Blood RNA system is a collection, stabilisation and purification method, automated or manual, for IVD use.
When blood is collected in a lab, clinicians and researchers are challenged by variations in expression profile and sample degradation that can be caused by sample collection, storage and transport conditions.
Some genes may be up or down regulated resulting in gene expression profiles becoming altered after the point of collection.
This can significantly alter the patient profile from what it was in vivo to what is seen at the point of analysis.
The Paxgene Blood RNA system is designed to stabilise whole blood in the tube at point of collection with CE-mark and FDA marketing clearance.
The standardisation and stability it provides is especially important in clinical situations where multiple sites, transport times and reproducibility are key issues.
The Paxgene blood collection tube contains a reagent that immediately stabilises intracellular RNA for up to three days at room temperature, and up to 50 months at -20 to -70C.
The ability to store and archive samples minimises the urgency to process them.
The Paxgene purification process is designed to provide high quality intracellular RNA from samples stabilised in the Preanalytix reagent.
Using the Paxgene Blood RNA system on the Qiacube provides customers with an integrated, automated approach to RNA purification.
The Paxgene Blood RNA kit is available in the US and Canada as version 762164, and in other countries as CE version 762174.
The handbook is available as part of the kit, as well as for download via the Qiagen website.
The protocol required to automate the Paxgene Blood RNA system on the Qiacube is also available for download.