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Polaris® RT-qPCR Buffer 2.5x, IVD

Storage Conditions:
-85 °C to -15 °C
Polaris® RT-qPCR Buffer 2.5x, IVD, is a validated Class A IVD reagent, designed to enhance the reliability and accuracy of RT-qPCR diagnostics that demand rapid amplification without compromising specificity or sensitivity. The buffer ensures optimal conditions for RT-PCR reactions by maintaining a stable pH and providing essential ions and cofactors that enhance enzyme efficiency.
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Polaris® RT-qPCR Buffer 2.5x, IVD, designed for in vitro diagnostic (IVD) applications, is a highly optimized buffer solution specifically developed to enhance the performance, reliability, and accuracy of RT-qPCR molecular diagnostics. This buffer includes the necessary components, additives, and stabilizers to support the activity of reverse transcriptases, DNA polymerases, and other accessory proteins during RT-qPCR. The Polaris® RT-qPCR Buffer 2.5x, IVD, provides optimal conditions for both reverse transcription and PCR amplification by maintaining a stable pH and supplying essential ions and cofactors that optimize enzyme efficiency. These features significantly reduce the likelihood of errors during the transcription and amplification processes and enhance the yield and specificity of the desired RT-qPCR products. Consequently, Polaris® RT-qPCR Buffer 2.5x, IVD, improves the reliability and accuracy of diagnostic RT-PCR, multiplex RT-PCR and RT-qPCR applications that demand rapid amplification without compromising specificity or sensitivity. Offered in a 2.5x concentration, this buffer is ideal for use in the concentrated bulk production of RT-qPCR reagents. It is specially formulated to promote highly efficient reverse transcription and PCR, stabilize enzymes, and enhance overall enzyme activity, facilitating its integration into various diagnostic workflows.

Polaris® RT-qPCR Buffer 2.5x, 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® RT-qPCR Buffer 2.5x, 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 (types A and B). The comprehensive validation of Polaris® RT-qPCR Buffer 2.5x, 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® RT-qPCR Buffer 2.5x, 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 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. Laboratories should validate performance for other targets according to local regulations and guidelines.

Polaris® RT-qPCR Buffer 2.5x, IVD, high concentration format and compatibility with lyophilization processes further enhance its utility in creating robust, sensitive, and specific diagnostic assays. This flexibility, when combined with the ability to customize assays with additional separate components, establishes Polaris® RT-qPCR Buffer 2.5x, IVD, as the go-to dNTP mix for diagnostic laboratories, PCR kit manufacturers and molecular testing facilities focused on crafting and deploying superior molecular diagnostics. The extensive validation and versatility of this product underscores Polaris® RT-qPCR Buffer 2.5x, 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® RT-qPCR
Marking CE-IVD
Internal Control No
Features Ultra-pure grade
RT-qPCR Buffer 2.5x
More Information
Shipping Conditions Blue Ice
Storage Conditions -85 °C to -15 °C
Format Liquid
Product Category Polaris® 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® RT-qPCR
Marking CE-IVD
Internal Control No
Features Ultra-pure grade

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