Polaris® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD

Polaris^® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD, designed for in vitro diagnostic (IVD) applications, represents a significant advancement in the field of molecular diagnostics, addressing the urgent need for rapid and reliable testing in global health contexts. Along with Polaris^® Glycerol-free HS TaqY Polymerase 28 U/µL, IVD, and Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, this enzyme is part of a second generation of molecular diagnostic enzymes tailored for RT-qPCR clinical applications. Provided in a high-concentration, glycerol-free formulation, it is especially suited for lyophilization, benefiting clinical settings where shipping and storage conditions can impact diagnostic test viability and where maintaining a cold chain may pose challenges.

Developed for high-speed, thermostability, and resistance to RT-qPCR inhibitors, Polaris^® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD, enables the generation of full-length cDNA fragments in minimized reaction times, as brief as one minute. Its enhanced thermostability permits successful transcription at temperatures up to 70 °C, effectively overcoming challenges posed by RNA secondary structures and enabling transcription even in the presence of GC-rich templates. For routine reverse transcription, 60 °C is generally the optimal temperature. A crucial advantage of this enzyme is its robust performance despite the presence of common RT inhibitors found in both clinical and non-clinical samples.

Manufactured under a rigorous quality management system compliant with global standards for IVD medical devices manufacturing, Polaris^® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD, ensures stringent quality assurance, complete traceability from production, and guaranteed reliability in diagnostic applications. The enzyme 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 Reverse Transcriptase Y 2 kU/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 validation and versatility of this enzyme underscores Polaris^® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD, as a robust class A diagnostic reagent, capable of accommodating varied diagnostic demands and capable of delivering reliable results across different biological matrices and testing conditions.

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Patent pending submitted by NZYtech.