APHL Position Statement: Field Testing Kits, Devices Must Be Validated

Not quite three months ago, the Association of Public Health Laboratories (APHL) issued a member-approved position statement, Standardized Validation of Screening Kits and Devices for Use in the Field toentify Hazardous Biological and Chemical Agents, developed by the association’s Emergency Preparedness and Response (EPR) Committee. The position statement is consistent with current guidance from the Department of Health and Human Services (HHS), which recommends against the use of field testing for biological agents. However, the APHL expanded on the HHS recommendation and stated that the association strongly opposes the use of biological and chemical-agent detection kits and devices for field testing in the absence of performance standardization, field validation, and the participation by certified individuals trained in the application of such kits and devices.  

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 Analytical results obtained in the field without appropriate device validation and performance training can yield false positive or false negative results 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(LINK CLOSED) 

Chris Mangal

Chris N. Mangal, MPH, is the director of public health 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 is responsible for providing programmatic and scientific leadership for preparedness activities for APHL members, staff, and partner organizations, such as the U.S. Centers for Disease Control and Prevention (CDC). She has more than 12 years of experience working to improve laboratory practice in the detection of public health threats, and to expand and enhance the relationships between APHL member laboratories and CDC, other federal agencies, and private organizations involved in emergency preparedness and response, public health testing, policy, and training.



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