Utilization of Standard Method Performance Requirements for the Detection of Coxiella burnetii in Environmental Samples
Abstract Background Coxiella burnetii, the causative agent of Q fever, has been a long-standing public health problem. Animals can become infected and shed the organism resulting in aerosol transmission to humans. This organism has been considered to have potential for use as a bioterrorism weapon and has been placed on the Select Agent List which is regulated by Health and Human Services (HHS) and United States Department of Agriculture (USDA). There has been limited assay development for the detection of C. burnetii in environmental sample types Objective We describe utilization of the Standard Method Performance Requirement (SMPR®) for the detection of Coxiella in air filters and liquids for validation of additional environmental samples. Method The SMPR® for the detection of Coxiella in air filters and liquids was used to validate a real-time polymerase chain reaction (rtPCR) assay developed to detect C. burnetii DNA in powder samples submitted to the public health laboratory for biothreat analysis. Conclusions The SMPR® provided important requirements needed for appropriate validation of an assay to detect Coxiella nucleic acid in an environmental sample. The assay was found to be sensitive, robust, specific, and is useful for the detection of this select agent in powders. Highlights Development of detection assays for agents that are difficult to culture and have limited validation material available can be problematic for manufacturers. Using the SMPR® developed for the detection of Coxiella as well as the SMPR® for the detection of Variola, we demonstrate that assays can be appropriately validated using alternative approaches.