Taking a step back from testing: Preanalytical considerations in molecular infectious disease diagnostics

Area of Science:

• Molecular diagnostics
• Infectious disease testing
• Preanalytical variables

Background:

• Laboratory errors predominantly occur during the preanalytical phase.
• Limited comprehensive resources exist on preanalytical and environmental factors influencing molecular diagnostic accuracy for infectious diseases.
• Accurate SARS-CoV-2 testing necessitates understanding variables impacting nucleic acid-based methods.

Purpose of the Study:

• To identify evidence-based factors affecting the outcome of nucleic acid-based molecular techniques for infectious disease diagnosis.
• To provide a comprehensive resource on preanalytical and environmental variables impacting molecular diagnostic accuracy.
• To promote efficient resource utilization in laboratory testing.

Main Methods:

• Systematic literature review of evidence-based factors impacting molecular diagnostic testing.
• Analysis of preanalytical and environmental variables affecting nucleic acid-based methods.
• Synthesis of documented factors influencing infectious disease diagnosis outcomes.

Main Results:

• Identified key preanalytical and environmental factors influencing nucleic acid test accuracy.
• Documented variables that promote accurate infectious disease diagnosis using molecular techniques.
• Highlighted the importance of controlling preanalytical conditions for reliable results.

Conclusions:

• Controlling preanalytical factors is critical for accurate molecular diagnostics.
• Understanding these variables enhances the efficiency and reliability of infectious disease testing.
• This review provides a foundation for optimizing molecular diagnostic workflows.