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Most molecular diagnostics laboratories focus on detecting specific, relatively short DNA or RNA fragments. This technology can diagnose infectious diseases, identify specific genetic variants affecting drug metabolism, or detect disease-related genes, such as cancer-associated genes. Key technologies in these tests include real-time quantitative polymerase chain reaction (PCR), transcription-mediated amplification (TMA), target amplification, and signal amplification. Sanger sequencing and DNA fragment analysis, often using capillary electrophoresis, are also crucial technologies but usually include amplification steps during detection. To successfully apply DNA and RNA-based diagnostic tests, molecular diagnostics laboratories must use well-defined workflows to achieve consistent and effective results. Special tools already exist to help these laboratories streamline each workflow step.

 Basic Detection Workflow

1.      Sample Collection and Preparation

Extract the genetic material to be tested from the sample.

2.      Amplification

Once the genetic material is isolated, it must be immediately amplified to detectable quantities for diagnostic purposes.

3.      Detection

Optical sensors read the signal corresponding to the target material after obtaining sufficient target material. The signal must be single or diverse to detect multiple target materials in one reaction (e.g., multiplex detection).

4.      Data Analysis

Analyze the signals read during the detection step. Convert the analysis results into interpretable information for laboratory personnel, ultimately providing diagnostic results for clinicians.