Testing of the Bio-Seeq (Smiths Detection Handheld PCR Instrument): Sensitivity, Specificity, and Effect of Interferents on Bacillus Assay Performance

摘要

Smiths Detection-Edgewood (SDE), Inc., recently developed a handheld PCR instrument, the Bio-Seeq(Trademark), an updated, redesigned version of the small, portable PCR instrument previously known as the Handheld Advanced Nucleic Acid Analyzer (HANAA). The SDE developed the Bio-Seeq(Trademark) to provide a portable platform for first responders to use for detecting biological threats in civilian areas. To be ready for introduction into the marketplace, the instrument must be accompanied by a menu of reagents that will enable the user to detect the presence of pathogens in environmental samples. In previous work, SDE obtained probe and primer sequences constituting an assay for a gene present in Bacillus anthracis, the causative agent of anthrax. The SDE incorporated this probe and primer set into dried reagent beads, which also contain reagents required for an internal control. These, in turn, are part of a self-contained sampling device that contains buffer and the PCR reagent beads. This report details an analysis of the assay for B. anthracis, including the sensitivity and specificity of the assay, and the effect of some common nontarget ('interferent') materials on the performance of the assay.