The APHL recognizes the potential usefulness of field kits and devices; however, their use without proper field validation and appropriate training is problematic. At sites where hazardous biological or chemical agents may be present, field screening kits and devices often are used by first responders to make decisions related to actions necessary to assure public safety. For chemical agents, although such field tests have been available for a number of years, minimum standards for performance have not been established. For biological agents, the kits and devices being developed commercially for this purpose have not been validated under field conditions. A Continuing Emphasis on Public Safety Validation is essential to ensure that kits and devices used in the field are appropriately sensitive and

specific to detect the agents for which they are designed. Analytical results obtained in the field without appropriate device validation and performance training can yield false positive or false negative results. Such data can be dangerously misleading.  Incorrect field test results may actually delay appropriate responses. In addition, failure to conduct field testing correctly, using standardized protocols prescribed by the validation process, may result in depletion of the sample material available with consequential loss of criminal evidence and the ability to conduct the appropriate confirmatory analytical testing essential for implementing effective public-safety and public-health measures.  In the absence of standardized and validated field kits and devices, public health laboratories must be contacted for confirmatory testing or guidance for such testing. The APHL position statement also addressed implementation steps, such as the need for a single federal entity – specifically, the U.S. Department of Homeland Security (DHS), Standards Portfolio – to establish standardized federal guidelines for the performance standardization and validation of all commercially developed screening kits and devices designed for use in the field by first responders to detect hazardous biological and chemical agents, including standards to assure adequate training. When standard parameters for validation and training established by these federal guidelines are met, each screening kit or device should be placed on a federal-approved list made available to all potential users.   The association further recommended that DHS collaborate with the Laboratory Response Network (LRN) reference laboratories during the validation process; all field testing results from credible threats should be confirmed at the nearest qualified LRN reference laboratory to guide state and local public health action. Additional recommendations focused on the need for DHS to develop and implement, through partnerships with other organizations, a training, certification, and proficiency testing program for first responders.

The APHL  position statement is available at http://www.aphl.org/policy/position_statements/APHLFieldDevicesPositionStatement.pdf ______________________________ Chris N. Mangal, MPH, is the senior manager for emergency preparedness and response at the Association of Public Health Laboratories (APHL). The recipient of a bachelor’s degree in microbiology from the University of Florida, and of a master of public health degree from the University of South Florida, she also serves as the staff liaison to the APHL Emergency Preparedness and Response Committee, working closely with federal, state, and local laboratorians in the Laboratory Response Network (LRN), and with other partners, to promote the role of public health laboratories in infectious disease detection and prevention and emergency preparedness.