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    The development of the polymerase chain reaction (PCR ) in the 1980s revolutionized molecular biology and has paved the way for technological advances that have improved the ability to detect and monitor disease. The genetic identification of disease-causing microbes, establishment of the Laboratory Response Network (LRN) for the detection of agents of bioterrorism, and enhancements to epidemiology and surveillance activities have all contributed to the implementation of molecular diagnostics into routine laboratory practices in public health laboratories. Classical testing methods such as culture or biochemical tests, although effective, can be slow, laborious, and in some cases, subject to interpretation. Conversely, molecular tests are powerful diagnostic tools that are advantageous in that they are rapid; in some cases, more sensitive and specific than classical methods; and useful for specimens containing fastidious bacteria and viruses. These diagnostics range from assays designed to detect a single target to multiplex assays that can detect multiple analytes within the same specimen. However, molecular diagnostics are not without their challenges and limitations. While many of the molecular tests used in public health laboratories are FDA-cleared, there are numerous assays for rare or emerging diseases that are developed and evaluated within a single laboratory. Laboratories that develop these types of tests need to perform appropriate validation to establish the performance characteristics and develop appropriate quality control (qc) and quality assurance (QA) practices to meet standards and guidelines developed under the Clinical Laboratory Improvement Amendments (CLIA ). Molecular diagnostic tests are an important tool used by public health laboratories as they perform specialized testing for the detection, characterization, and surveillance of diseases or conditions of public health significance. As molecular tests become the norm in public health laboratories, it is critical that laboratorians are well trained to perform, troubleshoot, and interpret the results of the assays, as well as understand the limitations (predictive values, contamination issues, inhibition) of the technology and results produced from the molecular tests.

    This report was supported by Cooperative Agreement Number #1U60HM000803 from CDC. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC.


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