Polaris® qPCR Master Mix Y 2x, IVD

Polaris^® qPCR Master Mix Y 2x, IVD, designed for in vitro diagnostic (IVD) applications, marks a significant advancement in the field of molecular diagnostics, meeting the urgent need for rapid and reliable testing in global health contexts. This master mix incorporates the latest generation of enzymatic innovations, including Polaris^® Glycerol-free HS TaqY Polymerase 20 U/µL, IVD, ensuring optimal performance in qPCR clinical applications. Engineered for stability, speed, and superior performance, this master mix includes a meticulously selected combination of buffers, additives and stabilizers. These components work synergistically with the Polaris^® Glycerol-free HS TaqY Polymerase to deliver exceptional inhibitor tolerance, rapid reaction kinetics and enhanced stability, facilitating qPCR cycling in under 30 minutes. Its robust resistance to common PCR inhibitors proves especially advantageous in clinical settings where variable sample purity can challenge the integrity of diagnostic assays. Formulated as a ready-to-use 2× master mix, this product contains all necessary components for real-time qPCR (including enzymes, dNTPs, stabilizers and enhancers), except for primers, probes and the testing clinical sample.

Manufactured under a rigorous quality management system, compliant with global standards for IVD medical devices manufacturing, Polaris^® 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^® qPCR Master Mix Y 2x, IVD, is a validated Class A IVD reagent, intended for professional use in the PCR detection of viral, bacterial and fungal DNA. Its performance characteristics have been established through tests targeting pathogenic bacteria, such as Group B Streptococcus (GBS). 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 DNA detection by qPCR.

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