Lessons in diagnostic virology: expected and unexpected sources of error

Area of Science:

• Clinical diagnostics
• Virology
• Medical laboratory science

Background:

• Viral diagnostic assays, including serological and molecular methods, have advanced significantly in sensitivity.
• Automated platforms and global market expansion increase the application of commercial assays in diverse settings.
• Novel diagnostic developments introduce new and often unexpected sources of error.

Purpose of the Study:

• To review case studies highlighting underappreciated diagnostic errors in viral testing.
• To examine errors across pre-analytical, analytical, and post-analytic phases of diagnostic processes.
• To propose methods for identifying and reducing the impact of diagnostic errors on patient management.

Main Methods:

• Review of case studies focusing on diagnostic errors in viral testing.
• Analysis of errors spanning pre-analytical, analytical, and post-analytic stages.
• Discussion of strategies for error detection and mitigation.

Main Results:

• Case studies reveal underappreciated and unexpected sources of diagnostic error in viral testing.
• Errors can occur at any stage of the diagnostic process: pre-analytical, analytical, and post-analytic.
• The globalization of diagnostics and use of automated platforms contribute to error emergence.

Conclusions:

• Despite advancements, diagnostic errors in viral testing remain a significant concern.
• Systematic approaches are needed to identify and address errors in viral diagnostics.
• Implementing strategies to reduce diagnostic errors is crucial for improving patient management and outcomes.