Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections

Respiratory infections have a high associated morbidity and mortality, especially in
immunocompromised patients. To initiate effective treatment of respiratory infections, it is
essential that a rapid and thorough laboratory analysis of respiratory specimens be
performed, given the wide range of pulmonary pathogens that can be detected in this
population. Conventional microbiology is time-consuming and cumbersome, and the capability of
local laboratories to assess specimens for rare or unusual pathogens is often limited. This
study will evaluate if a newer technology can be effectively utilized in the identification
of a broader range of infectious agents relative to conventional procedures.

Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased
operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical
specimen. The technology has had limited clinical application, but early studies have shown
its effectiveness in accurately identifying a large number of viral and bacterial organisms.
In contrast to conventional microbiological procedures based on phenotypic traits (growth
characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to
detect and identify the species, serotype/subtype, or strain of the infectious agent.

Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage,
BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be
analyzed using the customized microarray chip. The specimens will be collected as part of the
patients routine clinical care. The results of the TessArray microarray analysis will not be
available to the clinician and therefore will not have any effect on the clinical care of the
patients.

The results of the microarray analysis from each site will be compared to that site s
clinical laboratory results, and the data will be analyzed by site.