Validation of the T5000/PLEX-ID for system for the identification of etiologic agents of respiratory infection
Charlotte A. Gaydos heads up the project to validate a rapid, sensitive, specific and comprehensive platform capable of detecting various common pathogens, as well as atypical pathogens.
Febrile illnesses account for 10-20% of visits to emergency
departments (ED). For many patients, fever represents a
self-limiting and benign process. Occasionally, serious bacterial
or viral respiratory tract infections may be present which can
cause life threatening complications or death. The infectious agent
may be one of a number of commonly occurring pathogens acquired in
the community, or less frequently an atypical agent, or an emerging
biothreat (BT) pathogen.
Of increasing concern, as well, is the potential patient who
presents to the ED with a respiratory febrile illness who may be
infected with a BT agent. Prompt directed therapy based on an
identified pathogen is critical for optimizing patient outcome, and
protecting public concerns.
Unfortunately, front line clinicians are currently limited in
their ability to rapidly and reliably identify infectious agents.
Bacterial and viral culture, the current "gold standard" assays for
pathogen identification, is restricted by significant delays in
reporting of results (24-48 hours for bacteria and even longer for
viruses), and has relatively low sensitivity. These limitations
result in physicians waiting for results of tests, or initiating
empiric therapy. Potential problems associated with this approach
include delayed treatment, improper choice of therapeutic agent,
unnecessary use of antibiotics, and development of antibiotic
resistance. In the case of atypical, emerging and BT agents,
improper or delayed diagnosis has added costs associated with
contagion and delayed recognition and management of public health
Molecular based diagnostic methods have shown repeatedly to be
able to detect and identify various respiratory pathogens,
including bacteria, viruses and potential BT agents. Use of
molecular based diagnostics potentially facilitates ED physician
decision to direct appropriate therapy for the most severe cases,
particularly in the instance of a potential BT event.
The primary objective of this study was to evaluate the ability
of the Ibis Biosciences/Abbott Molecular T5000/PLEX-ID diagnostic
platform to accurately and rapidly detect and identify bacterial,
fungal, and viral pathogens associated with respiratory disease, in
various complex clinical samples.
Completed Project Overview
The purpose of this project was to assess the potential
capability of a novel technology, RT-PCR/ESI-MS, to potentially
impact andimprove public health and public health responses by
providing rapid and accurate diagnostic information regarding a
wide variety ofhuman pathogens including bacteria, fungi and
viruses. Multiple evaluations of this technology were performed on
various sample types,and again focused on a variety of human
pathogens, including Category A-C bacterial pathogens.
All evaluations indicated that use ofRT-PCR/ESI-MS via the
PLEX-ID as a diagnostic platform would provide timely sensitive and
specific diagnostic information aboutbacterial, viral and fungal
human pathogens. Five publications and seven scientific
presentations were generated from the workassociated with this