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Introducing a molecular test into the clinical microbiology laboratory: development, evaluation, and validation
1Department of Clinical Pathology, SUNY Upstate Medical University, Syracuse, NY 13210, USA. forbesb@upstate.edu
Archives of Pathology & Laboratory Medicine
|August 30, 2003
Summary
Molecular amplification assays, like polymerase chain reaction, have revolutionized diagnostics. Careful validation and correlation of results with clinical findings are crucial for maximizing their benefit in diagnosing infectious diseases.
Area of Science:
- Clinical Microbiology
- Molecular Diagnostics
- Infectious Disease Detection
Background:
- Polymerase chain reaction (PCR) technology, developed in the mid-1980s, transformed DNA amplification and clinical diagnostic testing.
- Despite advances in detecting infectious agents using amplification methods, limitations necessitate careful consideration.
Purpose of the Study:
- To outline key steps and challenges in implementing amplification assays in clinical microbiology labs.
- To describe ongoing activities required after assay implementation for routine use.
Main Methods:
- Literature searches from 1990-2002 using terms like "polymerase chain reaction" and "molecular assays."
- Analysis of National Committee for Clinical Laboratory Standards publications.
- Decomposition of assay introduction into four phases: development, analytical verification, clinical validation, and ongoing activities.
Main Results:
- Assay introduction involves distinct stages: initial development, analytical verification (sensitivity/specificity), clinical validation (sensitivity/specificity), and result interpretation/monitoring.
- Each stage presents unique advantages and limitations that require careful management.
Conclusions:
- Molecular testing significantly enhances the diagnosis of infectious diseases in clinical laboratories.
- Maximizing the clinical utility of molecular tests requires rigorous studies correlating assay results with patient clinical findings.