Polaris® (RT)-qPCR Buffer Y 2.5x, IVD

Polaris^® (RT)-qPCR Buffer Y 2.5x, IVD, designed for in vitro diagnostic (IVD) applications, represents a significant advancement in the field of molecular diagnostics. This buffer is engineered to meet the urgent need for rapid and reliable qPCR and RT-qPCR testing across global health contexts. Including essential components, additives, and stabilizers, this formulation is specifically chosen to support a broad range of enzymes, such as Polaris^® DNA polymerases and Reverse Transcriptases. The optimized composition maintains a stable pH and supplies critical ions and cofactors, enhancing enzyme efficiency and ensuring precise nucleic acid amplification. A distinctive feature of Polaris^® (RT)-qPCR Buffer Y 2.5x, IVD, is its exceptional stability, which promotes higher stabilization of qPCR and RT-qPCR enzymes and boosts resistance to clinical inhibitors commonly found in complex sample types. Moreover, the buffer’s ability to resist PCR inhibitors is vital for maintaining assay sensitivity and specificity, essential for the accurate detection of pathogens.

Manufactured under a rigorous quality management system compliant with global standards for IVD medical devices manufacturing, Polaris^® (RT)-qPCR Buffer Y 2.5x, IVD, ensures stringent quality assurance, complete traceability from production, and guaranteed reliability in diagnostic applications. This buffer 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 Buffer Y 2.5x, IVD, is a validated Class A IVD reagent, intended for professional use in the real-time PCR detection of viral, bacterial and fungal nucleic acids. Its performance characteristics were established through RT-qPCR tests targeting respiratory viruses, including SARS-CoV-2, and qPCR tests for detecting pathogenic bacteria such as Group B Streptococcus (GBS). Laboratories are advised to validate the performance of other pathogen targets following local regulations and guidelines.

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