Polaris® HS Taq Polymerase 20 U/µL, IVD

Polaris® HS Taq Polymerase 20 U/µL, IVD, designed for in vitro diagnostic (IVD) applications, is an optimized and highly robust hot-start DNA polymerase, meticulously designed to meet the high demands of modern medical diagnostics. Polaris® HS Taq Polymerase 20 U/µL, IVD, is an innovative formulation of the widely validated Polaris® Taq Polymerase 50 U/µL, IVD, equipped with an anti-Taq antibody that inhibits polymerase activity at ambient temperatures. This feature ensures that the enzyme remains inactive during the setup and initial stages of the PCR, thereby reducing non-specific amplification and improving the yield and specificity of the desired product. This enzyme is suitable for a variety of PCR applications including, but not limited to, singleplex, duplex and multiplex PCR, quantitative real-time PCR (qPCR) and RT-qPCR. The formulation boasts a high concentration of 20 U/µL, designed to facilitate the concentrated bulk production of PCR master mixes. Despite containing 20% glycerol to enhance stability and protection against freezing conditions, its high concentration ensures minimal glycerol incorporation into master mixes, thus maintaining compatibility with lyophilization processes. The result is a highly versatile enzyme that retains the reproducible performance expected in diagnostic applications, even when used in lower volumes. Accommodating a broad spectrum of PCR requirements, Polaris® HS Taq Polymerase 20 U/µL, IVD, is especially suited for challenging and multiplex PCR applications that demand rapid amplification without compromising specificity or sensitivity.

Polaris® HS Taq Polymerase 20 U/µL, IVD, is produced under a rigorous quality management system according to global standards for medical devices and IVD manufacturing, including stringent quality assurance, full traceability from production, and reliability in its diagnostic applications. The efficacy of Polaris® HS Taq Polymerase 20 U/µL, IVD, is especially relevant in the field of molecular diagnostics, as evidenced in this instruction manual through extensive validation for detecting a wide range of viral and bacterial pathogens, including SARS-CoV-2, Respiratory Syncytial Virus (RSV, subtypes A and B), Influenza (types A and B), methicillin-resistant Staphylococcus aureus (MRSA), and 14 high-risk types of Human Papillomavirus (HPV) in human clinical specimens. The comprehensive validation of Polaris® HS Taq Polymerase 20 U/µL, IVD, across diverse clinical matrices, not only underscores the enzyme's exceptional robustness and adaptability but also firmly establishes it as a validated Class A IVD reagent, setting a new standard in molecular diagnostics. The comprehensive validation of Polaris® HS Taq Polymerase 20 U/µL, IVD, across diverse clinical matrices, establishes it as a validated Class A IVD reagent for molecular diagnostics.

Features:

• Sensitivity and Specificity
• Accuracy and Reproducibility
• Stability and Robustness

Intended Use: Polaris® HS Taq Polymerase 20 U/µL, 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 in swab samples collected from patients. A positive result indicates the presence of pathogen nucleic acids but a clinical correlation with patient history and other diagnostic information is necessary to determine the patient's infection status. Negative results do not preclude microbial infection and should not be used as the sole basis for patient management decisions. Thus, the results obtained with this enzyme should be interpreted in conjunction with other clinical and laboratory findings. This IVD reagent is intended for use by properly licensed laboratory professionals. The performance characteristics of this product were established based on the detection of the respiratory viruses SARS-CoV-2, Influenza types A and B, and RSV, and other two highly relevant human pathogens, MRSA and HPV. Laboratories should validate performance for other targets according to local regulations and guidelines.

The extensive validation and versatility of this enzyme underscores Polaris® HS Taq Polymerase 20 U/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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