Scientific Publications by FDA Staff

J Mol Diagn 2005 Oct;7(4):486-94

A multiplex polymerase chain reaction microarray assay to detect bioterror pathogens in blood.

Tomioka K, Peredelchuk M, Zhu X, Arena R, Volokhov D, Selvapandiyan A, Stabler K, Mellquist-Riemenschneider J, Chizhikov V, Kaplan G, Nakhasi H, Duncan R

Duncan R, 1401 Rockville Pk,HFM310, Rockville, MD 20852 USA US FDA, Div Emerging & Transfus Transmitted Dis, Off Blood Res & Rev, Ctr Biol Evaluat & Res, Bethesda, MD USA US FDA, Div Hematol, Off Blood Res & Rev, Ctr Biol Evaluat & Res, Bethesda, MD USA US FDA, Div Viral Prod, Off Vaccines Res & Rev, Ctr Biol Evaluat & Res, Bethesda, MD USA

Heightened concern about the dangers of bioterrorism requires that measures be developed to ensure the safety of the blood supply. Multiplex detection of such agents using a blood-screening DNA microarray is a sensitive and specific method to screen simultaneously for a number of suspected agents. We have developed and optimized a multiplex polymerase chain reaction microarray assay to screen blood for three potential bioterror bacterial pathogens and a human ribosomal RNA gene internal control. The analytical sensitivity of the assay was demonstrated to be 50 colony-forming units/ml for Bacillus anthracis, Francisella tularensis, and Yersinia pseudotuberculosis (surrogate for Yersinia pestis). The absence of any false-positives demonstrated high analytical specificity. Screening B. anthracis-infected mouse blood samples and uninfected controls demonstrated effectiveness and specificity in a preclinical application. This study represents proof of the concept of microarray technology to screen simultaneously for multiple bioterror pathogens in blood samples.