Overcoming the Challenges of Accuracy and Detection in Molecular Assays

Molecular diagnostic tests are currently used for infectious disease testing due to the superior sensitivity and specificity that can be obtained. Due to the success that has been obtained with this application, molecular diagnostic testing is expected to grow into other areas such as genetic testing, prenatal testing, oncology, and pharmacogenomics. Growth in these areas will undoubtedly come with additional challenges due to the variety of the samples required, the presence of inhibitors, and low sample amounts, all of which contribute to potential false negative results due to poor amplification reactions.

In this presentation, we will demonstrate how a change in assay components can overcome these challenges. Specifically, we will address the issues that the Nucleic Acid Amplification Test (NAAT) (a commonly used diagnostic tool used for its fast turnaround and less invasive sample collection) has faced and how a change in enzyme selection impacted the overall quality and accuracy of the molecular diagnostic assay.

Learning Objectives

1. Classify key challenges in neucleic acid amplification tests.

2. Identify enzyme characteristics important for increased sensitivity, specificity, and speed.

3. Clarify how better PCR enzymes and reverse transcriptases can impact the accuracy and detection of molecular test assays.