Polaris® Glycerol-free HS TaqY Polymerase 28 U/µL, IVD

Polaris^® Glycerol-free HS TaqY Polymerase 28 U/µL, 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 testing in global health contexts. Along with Polaris^® Glycerol-free Reverse Transcriptase Y 2 kU/µL, IVD, and Polaris^® Glycerol-free RNase Inhibitor Y 160 U/µL, IVD, this enzyme is part of a second generation of molecular diagnostic enzymes tailored for both qPCR and RT-qPCR clinical applications. The enzyme is 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. Provided in a high-concentration, glycerol-free formulation, it is particularly suited for use in environments where shipping and storage conditions can impact diagnostic test viability and where maintaining a cold chain may pose challenges. This format is also ideal for lyophilization, enhancing the stability and ease of use of diagnostic kits.

Developed for high-speed, exceptional thermostability, and resistance to qPCR inhibitors, Polaris^® Glycerol-free HS TaqY Polymerase 28 U/µL, IVD, facilitates rapid DNA amplification, allowing complete enzyme reactions in minimized times, often under half an hour. Its enhanced thermostability enables effective DNA amplification at temperatures up to 95°C, thus accommodating a wide range of annealing temperatures and ensuring robust performance even with difficult or GC-rich templates. An additional crucial advantage of this enzyme is its high tolerance against common PCR inhibitors found in clinical and non-clinical samples, such as blood anticoagulants, proteins, uric acid, and isopropanol.

Manufactured under a rigorous quality management system compliant with global standards for IVD medical devices manufacturing, Polaris^® Glycerol-free HS TaqY Polymerase 28 U/µL, IVD, ensures stringent quality assurance, complete traceability from production, and guaranteed reliability in diagnostic applications. The enzyme 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
• High-concentration and Lyophilization Compatibility

Intended Use:

Polaris^® Glycerol-free HS TaqY Polymerase 28 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. This IVD reagent is intended for use by qualified laboratory professionals. 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 extensive validation and versatility of this enzyme underscores Polaris^® Glycerol-free HS TaqY Polymerase 28 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.

In case the IFU is not available in your official country language, please contact us – info@NZYtech.com so that we can proceed with the translation. Please see languages available below.


Find the IFU for your product batch