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Polaris® dNTP mix 25 mM, IVD

Storage Conditions:
-85 °C to -15 °C
Polaris® dNTP mix 25 mM, IVD, is a validated Class A IVD reagent, designed to improve the reliability and accuracy of diagnostic PCR, multiplex PCR, quantitative real-time PCR (qPCR), and RT-qPCR. This dNTP mix is crucial for precise DNA strand synthesis during PCR, significantly improving the performance of diagnostic PCR assays. The formulation is designed to remain stable under various PCR conditions, including lyophilization, ensuring seamless integration into different diagnostic workflows without the issues of nucleotide degradation.
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Polaris® dNTP mix 25 mM, IVD, designed for in vitro diagnostic (IVD) applications, is a meticulously optimized formulation of deoxynucleotide triphosphates (dNTPs) specifically developed for high fidelity in PCR amplification. This dNTP mix is essential for synthesizing DNA strands accurately during the PCR, thereby enhancing the performance of diagnostic PCR assays. The Polaris® dNTP mix 25 mM, IVD, mix ensures that the necessary nucleotides are available in balanced concentrations, promoting efficient and specific amplification. This key feature significantly reduces the likelihood of errors during DNA synthesis and enhances the yield and specificity of the desired PCR products. Polaris® dNTP mix 25 mM, IVD, 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 25 mM, this dNTP mix is ideal for use in the concentrated bulk production of PCR reagents. The formulation is designed to maintain stability under various PCR conditions, including those that require lyophilization, facilitating its integration into different diagnostic workflows without the complications associated with nucleotide degradation.

Polaris® dNTP mix 25 mM, 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® dNTP mix 25 mM, 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® dNTP mix 25 mM, 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® dNTP mix 25 mM, 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 product 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 product underscores Polaris® dNTP mix 25 mM, 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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More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Ultra-pure grade
dNTP mix 25 mM
More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Ultra-pure grade
More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Liquid
Product Category Polaris® qPCR & RT-qPCR
Marking CE-IVD
Internal Control No
Features Ultra-pure grade

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