Syndromic and Point-of-Care Molecular Testing

. Later, the implementation of real-time nucleic acid amplification chemistries permitted both faster pathogen detection and the enablement of nucleic acid quantitation

. These methods quickly migrated from research laboratories into clinical laboratories, first as laboratory-developed tests or so-called home brew tests. This revolution enabled laboratorians to more precisely identify the causes of infectious diseases by detecting pathogen-specific nucleotide sequences in cultured isolates and clinical specimens. Many of these methods proved to be far superior in terms of accuracy and result TAT compared with cultivation-dependent approaches, especially for the identification of viruses. Over time, these methods also underwent refinements that included the adaptation of several assays to automated platforms, allowing users to minimize the manual handling of specimens and reaction components.

One recent advancement in pathogen detection is the syndromic approach in which groups of pathogens are tested for simultaneously in a single reaction vessel. These assays incorporate components of older methods, including real-time PCR; however, rather than ordering separate tests for various pathogens, the syndromic tests allow simultaneous detection of a variety of agents that are associated with a specific disease syndrome

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The newest systems are those that allow users to perform laboratory-quality molecular testing at the point of patient care, a major advancement that has moved molecular pathology to the forefront of modern diagnostics. Many Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care (POC) systems are now available and permit rapid result reporting, enabling prescription of targeted treatment at the time of clinic visit. The current assays on these platforms largely target infections diagnosed in the ambulatory setting such as influenza and streptococcal pharyngitis.