Assuring result quality: Emerging and biosecurity nicrobiological agents

ABSTRACT

Background: Quality assurance (QA) of testing is important for our ability to be certain results we provide to patients are accurate and definitive. Testing agents of biosecurity concern includes Security Sensitive Biological Agents (SSBA) such as Tier 1 agents (anthrax, Ebolavirus, influenza, HPAI, SARS, smallpox, plague) and Tier 2 agents (swine fever, botulism, Tularaemia, yellow fever, etc). Test QA is limited by need for containment at BSL3 and BSL4 level, difficulties accessing reagents due to serious public health consequences of organism release, and increasing regulation. Methods in providing QA The Biosecurity Quality Assurance Program (BSQAP) was formed after 2008 when the SSBA Regulatory Scheme for control of select agents was established. The program addresses the unique problems of SSBA by utilising novel methods for QA, including subgenomic non-infectious molecular targets, online e-learning, and recently whole genome sequencing (WGS) programs assessing new technologies. Discussion(s) Emerging technologies (multiplex Biofire systems, WGS) and continuing emergence of novel threats (Ebolavirus, HPAI) mean laboratories need rapid, accurate QA support. Tests introduced nationally by reference laboratories in response to emergent threats often lack prior QA, experience, and appropriate reagents. Addressing these systematically through regulatory preparedness (the 'PHLN' module, early governmental engagement), novel methodologies (above), high level engagement (Commonwealth, WHO, AFP) and expertise has assisted successful public health responses. Acknowledgements BSQAP program members Joanna Gray, Torsten Theis, Katherine Lau, Peter Santosa, RCPQAP Tony Badrick, Commonwealth Government. References 1. Lau KA, Theis T, Gray J, et al. Ebola preparedness diagnosis improvement using rapid approaches for proficiency testing. J Clin Microbiol 2016;55 783-90. 2. Theis T, Lau KA, Gray J, et al. Proficiency testing for the detection of Middle East respiratory syndrome-coronavirus demonstrates global capacity to detect MERS-CoV. J Med Virol 2018;90 1827-33. Copyright © 2020