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Polaris® Reverse Transcriptase 285 U/µL, IVD

Storage Conditions:
-85 °C to -15 °C
Polaris® Reverse Transcriptase 285 U/µL, IVD, is a validated Class A IVD reagent, designed to ensure efficient and accurate synthesis of cDNA from RNA templates in RT-qPCR molecular diagnostic applications. The enzyme ensures optimal reverse transcription by maintaining high activity and stability across various reaction conditions. Despite containing 50% glycerol for stability and freeze protection, its high concentration ensures minimal glycerol inclusion in master mixes, preserving compatibility with lyophilization processes.
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Polaris® Reverse Transcriptase 285 U/µL, IVD, designed for in vitro diagnostic (IVD) applications, is a highly effective and stable enzyme engineered to enhance the performance, reliability, and accuracy of RT-qPCR molecular diagnostics. This reverse transcriptase is specifically developed to ensure efficient and accurate synthesis of cDNA from RNA templates, which is critical for successful RT-qPCR. The enzyme provides optimal conditions for reverse transcription by maintaining high activity and stability under a range of reaction conditions. This feature is crucial for minimizing the likelihood of errors during the transcription process, thereby enhancing the yield and specificity of the desired RT-qPCR products. By facilitating accurate and efficient cDNA synthesis, Polaris® Reverse Transcriptase 285 U/µL, IVD, significantly improves the reliability and accuracy of diagnostic RT-PCR, multiplex RT-PCR, and quantitative RT-qPCR applications. Despite containing 50% glycerol to enhance stability and protect 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 RT-qPCR requirements, Polaris® Reverse Transcriptase 285 U/µL, IVD, is especially suited for challenging and multiplex RT-qPCR applications that demand rapid transcription and amplification without compromising specificity or sensitivity.

Polaris® Reverse Transcriptase 285 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® Reverse Transcriptase 285 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 RNA viral pathogens, including SARS-CoV-2, Respiratory Syncytial Virus (RSV, subtypes A and B) and Influenza Virus (types A and B). The comprehensive validation of Polaris® Reverse Transcriptase 285 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® Reverse Transcriptase 285 U/µL, IVD, is a validated Class A IVD reagent, intended for professional use in the real-time PCR detection of RNA virus in nasopharyngeal or oropharyngeal swabs samples collected from patients. A positive result indicates the presence of pathogen RNA 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. Laboratories should validate performance for other targets according to local regulations and guidelines.

The extensive validation and versatility of this enzyme underscores Polaris® Reverse Transcriptase 285 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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More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® RT-qPCR
Marking CE-IVD
Protocol time 10 min
Internal Control No
Features Fast, Stable & Robust
RTase 285 U/µL
More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® RT-qPCR
Marking CE-IVD
Protocol time 10 min
Internal Control No
Features Fast, Stable & Robust
More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Enzyme/Protein, Liquid
Product Category Polaris® RT-qPCR
Marking CE-IVD
Protocol time 10 min
Internal Control No
Features Fast, Stable & Robust

MSDS

Material Safety Data Sheets

CoA

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