Consensus Report

BioWatch PCR Assays: Building Confidence, Ensuring Reliability; Abbreviated Version (2015)

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Biowatch is an air monitoring system deployed in jurisdictions around the country with the goal of detecting the presence of certain high risk pathogenic microorganisms as part of intelligence-gathering and biomonitoring activities that support public safety and health.

This report examines standards for PCR assays appropriate for the BioWatch program, providing recommendations on general principles for a performance standard and validation framework to meet BioWatch's mission. The report draws on a base of existing guidance for characterizing performance of pathogen detection PCR assays in order to provide a starting point for a laboratory testing strategy appropriate for BioWatch.

For PCR assays to provide sufficient confidence to users, the BioWatch program, federal agency partners, and stakeholders in state and local jurisdictions need to share assay performance information, understand the limitations of laboratory-based assay performance testing for operational decision-making, and discuss issues that arise, the report finds. The report also considers how developments in technology, particularly in multiplex PCR and next-generation sequencing, could help the BioWatch program to meet current and future challenges. Working with technology experts and laboratory users in the BioWatch jurisdictions would help ensure that new technology brought into the program functions smoothly for the stakeholder community.