Polaris® RT-qPCR Master Mix Y 2x, IVD

Polaris^® RT-qPCR Master Mix Y 2x, IVD, designed for in vitro diagnostic (IVD) applications, represents a significant advancement in molecular diagnostics, meeting the urgent need for rapid and reliable testing in global health contexts. This master mix integrates the latest generation of enzymatic innovations, including Polaris^® Glycerol-free HS TaqY Polymerase 20 U/µL, IVD, Polaris^® Glycerol-free Reverse Transcriptase Y 1 kU/µL, IVD, and Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, ensuring effective performance in RT-qPCR clinical applications. Engineered for optimal stability, speed and performance, the master mix features a meticulously selected combination of buffers, additives and stabilizers that, together with the Polaris Y enzymes, deliver inhibitor tolerance, rapid reaction kinetics and enhanced stability. The master mix's increased speed enables reverse transcription in just one minute at 60 °C, and its robust resistance to common RT-PCR inhibitors is particularly advantageous in clinical settings where varying sample purity can pose challenges to the integrity of diagnostic assays. Formulated as a ready-to-use 2× master mix, this product contains all necessary components for cDNA synthesis and real-time PCR (including enzymes, dNTPs, stabilizers and enhancers), except for primers, probes and the testing RNA sample.

Manufactured under a rigorous quality management system, compliant with global standards for IVD medical devices manufacturing, Polaris^® RT-qPCR Master Mix Y 2x, IVD, includes stringent quality assurance, complete traceability from production and guaranteed reliability in diagnostic applications. This master mix 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

Intended Use:

Polaris^® RT-qPCR Master Mix Y 2x, IVD, is a validated Class A IVD reagent t, intended for professional use in the real-time PCR detection of RNA virus. 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 pre-mixed format of this Class A diagnostic reagent simplifies assay setup, minimizes contamination risk and ensures consistent results across various diagnostic settings. This reagent's flexibility makes it ideally suited for diverse molecular diagnostic applications, particularly those involving RNA detection by RT-qPCR.

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