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Polaris® Glycerol-free Taq Antibody 10 mg/mL, IVD

Storage Conditions:
-85 °C to -15 °C
Polaris® Glycerol-free Taq Antibody 10 mg/mL, IVD, is a validated Class A IVD reagent, designed to improve the reliability and accuracy of diagnostic PCR, real-time PCR (qPCR) and RT-qPCR. This reagent is essential for establishing hot start conditions, significantly improving the performance of diagnostic PCR assays. The glycerol-free formulation is specially designed to maintain compatibility with various PCR setups, including those that require lyophilization.
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Polaris® Glycerol-free Taq Antibody 10 mg/mL, IVD, designed for in vitro diagnostic (IVD) applications, is an optimized antibody formulation specifically developed to modulate the activity of TAQ DNA polymerase by inhibiting its activity at lower temperatures. This anti-Taq antibody preparation is crucial in creating hot start conditions for real-time PCR, thereby enhancing the performance of diagnostic PCR assays. The Polaris® Glycerol-free Taq Antibody 10 mg/mL, IVD, binds to Taq polymerase, ensuring that the enzyme remains inactive during the setup and initial stages of PCR. This key feature significantly reduces non-specific amplification and enhances the yield and specificity of the desired PCR products. By doing so, it improves the reliability and accuracy of diagnostic PCR, multiplex PCR, quantitative real-time PCR (qPCR), and RT-qPCR applications. Offered at a high concentration of 10 mg/mL, this antibody is ideal for use in the concentrated bulk production of PCR reagents. The glycerol-free formulation is specially designed to maintain compatibility with various PCR setups, including those that require lyophilization. Accommodating a broad spectrum of PCR requirements, Polaris® Glycerol-free Taq Antibody 10 mg/mL, IVD, is especially suited for challenging and multiplex PCR applications that demand rapid amplification without compromising specificity or sensitivity.

Polaris® Glycerol-free Taq Antibody 10 mg/mL, 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® Glycerol-free Taq Antibody 10 mg/mL, 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® Glycerol-free Taq Antibody 10 mg/mL, 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® Glycerol-free Taq Antibody 10 mg/mL, 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 tests using this antibody 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.

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More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Stable & Robust
GF Taq Ab 10 mg/mL
More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Stable & Robust
More Information
Shipping Conditions Room Temperature
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Stable & Robust

MSDS

Material Safety Data Sheets

CoA

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