Polaris® Lyophilizable (RT)-qPCR Buffer Y 2.5x, IVD

Polaris^® Lyophilizable (RT)-qPCR Buffer Y 2.5x, 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 qPCR and RT-qPCR testing in global health contexts. The buffer includes essential components, additives, stabilizers and lyophilization excipients specifically chosen to support the activity of a broad range of enzymes, including Polaris® DNA polymerases and Reverse Transcriptases. This optimized formulation creates an ideal environment for both qPCR and RT-qPCR reactions by maintaining a stable pH and supplying essential ions and cofactors, thereby enhancing enzyme efficiency and ensuring precise nucleic acid amplification. A key feature of the Polaris® Lyophilizable (RT)-qPCR Buffer Y 2.5x, IVD, is its enhanced formulation that allows for higher stabilization of qPCR and RT-qPCR enzymes and increased resistance to clinical inhibitors, which are often present in complex sample types. This upgraded formulation contains excipients at a balanced concentration, allowing users to dilute it with appropriate enzymes up to a 2x working concentration and proceed directly to lyophilization. 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^® Lyophilizable (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
• Optimized for Direct Lyophilization at 2x Concentration

Intended Use:

Polaris^® Lyophilizable (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.

The versatility of this buffer ensures optimal performance in a variety of qPCR and RT-qPCR diagnostic applications, making it exceptionally well-suited for a broad range of molecular diagnostics. This includes applications that require precise cDNA synthesis and effective qPCR detect.

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