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Quality Control: Molecular Diagnostics

Quality Control: Molecular Diagnostics. Overview. Sample Collection, Transport, and Processing maintain Nucleic acid integrity through these processes Contamination Control

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Quality Control: Molecular Diagnostics

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  1. Quality Control: Molecular Diagnostics

  2. Overview Sample Collection, Transport, and Processing maintain Nucleic acid integrity through these processes Contamination Control establish a unidirectional work flow from a DNA-free area for reagent preparation, to a sample processing area, to area where amplification and detection occur Positive and Negative Controls Reference: CLSI MM3-A (Molecular Diagnostic Methods for Infectious Diseases) Molecular Diagnostics Quality Control - Module 8 2

  3. Quality Control: Molecular Diagnostics Molecular Diagnostics Quality Control - Module 8 3

  4. Real Time PCR SAMPLE Amplified Target NA Taq polymerase Quantitative Fluorescence PRIMER SYBR Green + - In Molecular Diagnostics Quality Control - Module 8 5

  5. Amplification Reactions POSITIVE NO AMPLIFICATION Amplification / Time Molecular Diagnostics Quality Control - Module 8 6

  6. Real Time RT-PCR Molecular Diagnostics Quality Control - Module 8 7

  7. A/H3 Molecular Diagnostics Quality Control - Module 8 8

  8. A/H5 Molecular Diagnostics Quality Control - Module 8 9

  9. Risks with PCR most RT-PCR is still done as “in-house” or “home-brew” primers are not necessarily optimized to test positive controls are “in-house” negative controls are “in-house” interpretation of tests need to be done with caution Molecular Diagnostics Quality Control - Module 8 11

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