The AffiCHECK VZV PCR controls are utilized in laboratory settings to validate the performance and accuracy of VZV PCR tests. These controls help in the detection and quantification of VZV DNA, ensuring the PCR assay functions correctly and consistently. They are essential for confirming the sensitivity and specificity of PCR assays in detecting VZV.
Content and Specifications
- Components:
- Positive Control: Contains a known quantity of VZV DNA to confirm the assay's ability to detect the virus at expected levels.
- Negative Control: Ensures that there is no contamination and verifies the specificity of the assay.
- Quantitative PCR Quality Control Levels:
- Different levels of controls (e.g., L1, L2, L3) are available, each representing various concentrations of VZV DNA to test the dynamic range of the PCR assay.
- Key Features:
- Detection and Quantification: Measures VZV DNA levels in copies per milliliter (copies/mL).
- Internal Control and Standards: Includes internal controls and quantification standards to ensure accurate results.
- Compatibility: Compatible with various real-time PCR platforms, making it versatile for different laboratory setups.
- Regulatory Compliance: CE-IVD marked, indicating it meets the European In Vitro Diagnostic standards.
- Sample Types:
- Suitable for a variety of human samples, including blood (EDTA), cerebrospinal fluid (CSF), and lesion swabs, ensuring comprehensive testing across different specimen types.
- Usage:
- The controls are used to monitor the entire PCR process, from sample extraction to amplification, ensuring the reliability of diagnostic results.
Application
These controls are essential for diagnostic laboratories performing VZV PCR tests, particularly for diagnosing conditions such as chickenpox and shingles. They help in routine quality checks and validation of new PCR assays, ensuring the robustness and accuracy of test results.
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