PAXgene Blood RNA Tubes (IVD)
For collection of whole blood samples for molecular diagnostic testing
The PAXgene Blood RNA Tube (IVD) is a component of the PAXgene Blood RNA System, which additionally includes the PAXgene Blood RNA Kit (IVD) for nucleic acid purification. The PAXgene Blood RNA System is intended for the collection, transport and storage of blood and the stabilization of intracellular RNA in a closed tube with subsequent isolation and purification of intracellular RNA for RT-PCR used in molecular diagnostic testing.
The patented additive in PAXgene Blood RNA Tubes (IVD) protects RNA molecules from degradation by RNases and other enzymes, and triggers the complete lysis of all cells in the sample to minimize ex vivo changes in gene expression due to gene induction and downregulation. The result is immediate and long-term stabilization of RNA in specimens, even after being stored for up to 3 days at room temperature (see figures "RNA stability at 18–25°C: FOS" and "RNA stability at 18–25°C: IL1B") or up to 5 days refrigerated (see figures "RNA stability at 2–8°C: FOS" and "RNA stability at 2–8°C: IL1B"). Currently available data show stabilization of intracellular RNA for up to 96 months at –20°C or –70°C.
The collection of whole blood is the first step in many molecular assays used to study intracellular RNA. A major challenge in this type of testing is the instability of intracellular RNA, which rapidly degrades within hours after blood collection. Furthermore, certain transcript levels change after blood collection due to ex vivo gene regulation, such as induction and repression. Both RNA degradation and gene regulation can lead to an under- or overestimation of in vivo gene expression profiles.
Whole blood is collected directly into the PAXgene Blood RNA Tube (IVD) using standard phlebotomy practice and equipment. The RNA in the specimen is immediately stabilized for storage at room temperature, refrigerated or frozen. RNA must be purified using the PAXgene Blood RNA Kit (IVD) for molecular diagnostics applications. PAXgene Blood RNA Tubes (IVD) can be combined with other PAXgene Blood RNA kits for Research Use Only (RUO) applications.
The ease of collection, stabilization of RNA at different temperatures and elimination of additional processing steps (e.g., centrifugation, storage on ice) standardizes the workflow from collection to purification, reducing variability that can be introduced by different operators (see figure "Repeatability and reproducibility of RNA yield for different operators and PAXgene Blood RNA Kit lots").
Used together, the PAXgene Blood RNA Tube (IVD) and the PAXgene Blood RNA Kit (IVD) constitute the FDA-cleared, CE-marked PAXgene Blood RNA System to enable the purification of intracellular RNA from whole blood for applications in molecular diagnostic testing, such as real-time RT-PCR analysis of specific transcripts.
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