Polaris® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD

Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, designed for in vitro diagnostic (IVD) applications, represents a significant advancement in molecular diagnostics, specifically engineered to enhance the integrity and stability of RNA samples. This inhibitor is part of a new generation of molecular diagnostic tools, essential for reliable RNA-based testing across global health landscapes. It is characterized by its ability to function effectively under diverse reaction conditions, maintaining inhibitory activity even at elevated temperatures. This versatility makes it suitable for advanced molecular diagnostics, including those requiring high-temperature steps to resolve RNA secondary structures or process GC-rich regions effectively. Showing a high affinity for a broad spectrum of RNases, not limited to RNase A, this RNase inhibitor protects RNA from degradation by a wide array of RNases that might otherwise compromise RNA molecules before and during the RT-qPCR process. Provided in a high-concentration, glycerol-free formulation, it is ideally suited for lyophilization.

Moreover, Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, is developed to integrate seamlessly into fast RT-qPCR Polaris® protocols and exhibits significant resistance to PCR inhibitors. Rapid assay turnaround is crucial for effective disease management and outbreak control, particularly in acute and emergency scenarios. Furthermore, resistance to PCR inhibitors is vital for maintaining the assay's sensitivity and specificity, which are essential for the accurate detection of pathogens.

Manufactured under a rigorous quality management system compliant with global standards for IVD medical devices manufacturing, Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, ensures stringent quality assurance, complete traceability from production, and guaranteed reliability in diagnostic applications. This RNase inhibitor has undergone extensive validation studies to ensure its performance and compliance with Class A IVD requirements. The most important features of this product are:

• Sensitivity and Speed
• Superior Inhibitor Tolerance
• Stability and Accuracy
• High-concentration and Lyophilization Compatibility

Intended Use:

Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, is a validated Class A IVD reagent, intended for professional use in the real-time PCR detection of RNA virus. This IVD reagent is intended for use by qualified laboratory professionals. Its performance characteristics were established through tests targeting respiratory viruses such as SARS-CoV-2. Laboratories are advised to validate the performance of other pathogen targets following local regulations and guidelines.

The extensive validations and versatility of Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, underscore its utility as a robust and complete solution for diagnostic laboratories. As a Class A diagnostic reagent, this protein meets the highest standards of performance and reliability required for critical diagnostic tasks.

In case the IFU is not available in your official country language, please contact us – info@NZYtech.com so that we can proceed with the translation. Please see languages available below.


Find the IFU for your product batch