Lab Matters Summer 2019 - Page 79

APHL 2019 POSTER ABSTRACTS Improving Crisis and Emerging Threat Responses in Public Health Laboratories Evaluation of MERS-CoV Testing Capability Among US Laboratory Response Network Laboratories R. Aubert 1 , E. Bind 2 , M. Bonifas 3 , C. Charlton 4 , C. Courtney 5 , N. Hull 6 , M. Johnson 7 , R. McNall 1 , C. Perkins 8 , C. Sloma 9 , S. Staley 10 , A. Strain 11 , T. Wolford 10 , R. Razzaque 12 ; 1 Centers for Disease Control and Prevention, 2 New Jersey Department of Health, 3 Michigan Department of Health and Human Services, 4 Provincial Laboratory for Public Health, 5 Washington, DC Public Health Laboratory, 6 Wyoming Public Health Laboratory, 7 Kentucky Division of Laboratory Services, 8 Los Angeles County Public Health Laboratory, 9 Texas Department of State Health Services, 10 Association of Public Health Laboratories, 11 Minnesota Department of Health, 12 Oregon State Public Health Laboratory B. Whitaker, D. Erdman, E. Schneider, N. DeGroote, S. Sakthivel, X. Lu, L. Lowe, P. Syribeys and S. Lindstrom, Centers for Disease Control and Prevention Background: Public health laboratories (PHLs) and public health associated institutional laboratories (PHAIs) are facing an increasing number of threats that negatively affect the ability of laboratories to provide uninterrupted services. To ensure an undiminished standard for public health and safety, it is imperative that PHLs and PHAIs have the capability and capacity to prepare for and respond to threats through improved collaboration and resource gathering. Cohort 11 of APHL’s Emerging Leader Program aims to provide accessible, user-friendly, and relevant information to utilize for improving emergency response and crisis management. Methods: In the fall of 2018, APHL’s Emerging Leaders Program Cohort 11 includes a diverse group of fifteen public health professionals, including representatives from US state and local PHLs, the Centers for Disease Control and Prevention, Public Health Canada, and APHL. The topic of public health preparedness and emergency response was selected by Cohort 11 as an unmet need with overarching relevance, and an issue that aligned with APHL’s strategic priorities. The cohort determined that a publication identifying gaps and lessons learned in crisis response would provide information to both public health professionals and policy makers. The cohort will collate the knowledge and experiences shared by subject-matter experts to convey these lessons into a document and summary fact sheet. To enhance existing resources, Cohort 11 is also facilitating a round-table discussion of this topic at the APHL Annual Meeting. Results: Cohort 11 will create a document which highlights challenges for the PHLs in responding to crisis and emerging threats, including biological, chemical, natural disasters, and technological issues. Challenges may involve personnel, resources, tests systems, monitoring, reporting, and communication during the response. Through consultations with experts, the document will not only address the gaps in the preparedness program, but will also provide a thoughtful and detailed summary of our findings which will be useful for state public health laboratory leaders and policy makers, the federal government laboratories, and for PHLs globally. Background: In 2012 a novel coronavirus was identified as the cause of Middle East Respiratory Syndrome (MERS-CoV). The Centers for Disease Control and Prevention (CDC) rapidly developed and deployed diagnostic real-time RT-PCR (rRT-PCR) assays under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Diagnostic assay kits were deployed to laboratories belonging to the CDC Laboratory Response Network (LRN) that include U.S. public health laboratories (US PHLs) and Department of Defense laboratories that have been qualified to perform testing on patients under investigation (PUIs) for MERS-CoV. CDC has assessed those testing capabilities by conducting annual performance evaluations of any US PHL receiving the CDC Novel Coronavirus 2012 Real-Time RT-PCR Assay (MERS-CoV assay). Methods: In order to evaluate the performance of US PHLs performing the CDC MERS-CoV assay, CDC developed a MERS- CoV External Quality Assessment (EQA) panel comprised of mock respiratory specimens covering a range of strong to weak positive samples. Mock specimens were manufactured by serially diluting a gamma radiation inactivated MERS-CoV virus isolate in commercial viral transport media (VTM) along with clean, uninfected A549 human cells. Single-blinded EQA panels were shipped to qualified LRN laboratories and processed as clinical respiratory specimens and tested by the CDC MERS-CoV assay. Results were reported back to CDC for confidential grading where a passing performance consisted of correct qualitative results and cycle threshold (Ct) values within 2 standard deviations of internal values replicated by CDC. Results and Conclusions: Initial evaluation in 2013 showed 84% of LRN labs passed the EQA panel on the first try. Through ongoing technical laboratory support, performance improved to 88% in 2014, 94% in 2015, 96% in 2016 and 100% in 2017-2018. CDC was able to determine several areas of improvement such as specimen processing, reagent preparation and data analysis issues. In total, 16 performance issues were identified from 2013-2016 among 15 individual laboratories. From 2013-2018, qualified LRN labs have tested over 1300 PUIs for MERS-CoV infection. Notably, 2 patients in 2014 tested positive for MERS-CoV which were found to be imported from Saudi Arabia. Currently there are 57 qualified LRN laboratories in the U.S. capable of performing MERS-CoV diagnostic testing using the CDC MERS-CoV assay. Presenter: Brett Whitaker, Centers for Disease Control and Prevention, Atlanta, GA, Conclusion: To build a stronger public health network, we must establish effective communication and coordinated response within the PHLs during the crisis events as well as establish efficient public communication strategy. APHL Cohort 11 will provide a document and forum to assist this priority by sharing knowledge across laboratories and providing information, which can be used to prepare for emerging public health threats. Presenter: Rafia Razzaque, Oregon State Public Health Laboratory, PublicHealthLabs @APHL Summer 2019 LAB MATTERS 77