Lab Matters Summer 2018 - Page 82

APHL 2018 Annual Meeting Poster Abstracts PHL Capacity Preparedeness and Response Transition of a Manually-Performed Laboratory-Developed Test (LDT) to the Fully Automated cobas ® 6800/8800 Systems Using the cobas ® omni Utility Channel Resources for Sentinel Clinical Lab Partnerships R. Hein, C. McGowin, S. Cagas, S. McCune, P. Rodriguez, S. Moseley, J. Osiecki and J. Engstrom, Roche Diagnostics, Inc., Indianapolis, IN The Association of Public Health Laboratories (APHL) provides key resources to public health laboratories (PHLs) through the Sentinel Laboratory Partnerships and Outreach Subcommittee (SLPOS) to assist members in their ability to effectively communicate with and provide guidance to sentinel clinical laboratories. In fiscal year 2018, along with input from the American Society for Microbiology (ASM) and the Centers for Disease Control and Prevention (CDC), SLPOS members developed and updated resources that focus on the critical linkage between public and private la boratories. New activities this year encompassed updating the Sentinel Level Clinical Laboratory Definition, which articulates the role of sentinel laboratories in the Laboratory Response Network (LRN) and outlines the responsibilities of LRN Reference PHLs in support of sentinel clinical laboratories; review of and updated design to the Biothreat Agent Bench Cards for Sentinel Clinical Laboratories and the affiliated Bioterrorism Agents Poster, which are a detailed yet easy to use resource to assist laboratorians with quick identification of certain Tier 1 Select Agents; publication of scientific data illustrating the safety and accuracy of MALDI-TOF technology; and participation in newly formed Clinical Laboratory Partners Workgroup, which is led by the CDC/Division of Laboratory Systems and provides an opportunity for CDC and professional laboratory organizations to collaborate to address the needs of clinical and public health laboratories and to facilitate improved communication between the public health and private sector. The resources developed by the members of SLPOS are integral in aiding communication between PHLs and their local sentinel clinical laboratories. They are vital in support of the mission in assisting with quick and accurate detection of public health threats. Introduction: Laboratory-developed tests (LDTs) remain an integral component of patient management within US clinical laboratories, most commonly for infectious disease testing when an FDA- approved IVD option is unavailable. Additionally, LDTs often afford rapid responses to outbreaks and emerging threats and therefore are important elements of laboratory medicine and public health. Unfortunately, LDTs are often labor intensive and typically require several instruments to complete the testing workflow. As diagnostic testing menus expand and complexity of laboratory workflow increases, the need for LDT automation is unequivocal. The cobas ® 6800/8800 Systems are fully automated, sample-to-result platforms for routine or high-volume molecular testing that relies on TaqMan ® -based PCR detection. The cobas ® omni Utility Channel facilitates the automation of user-defined PCR tests, including sample pipetting from primary/secondary tubes, nucleic acid extraction, reaction setup and amplification and result reporting. Here, we demonstrate the transition process for converting a labor- intensive manual LDT onto the cobas ® 6800/8800 Systems. Methods: The cobas ® omni Optimization kit, which contains the universal cobas ® omni master mix reagents, was used for off-board optimization of a LDT following a stepwise process. After optimizing the reaction conditions, assay performance was verified on the cobas ® 6800 System; all tests runs incorporated AmpErase as an effective contamination prevention measure, as well as an optional universal internal control. Importantly, the only manual step was pipetting the cobas ® omni Utility Channel Master Mix Reagents into a cobas omni Utility Channel reagent cassette, which is loaded onto the cobas ® 6800 System alongside clinical specimens. Results: Use of the cobas ® omni Optimization kit facilitated the transition onto the cobas ® 6800 System. The stepwise workflow demonstrated the optimization of an established TaqMan ® -based Trichomonas vaginalis LDT prior to transitioning onto the cobas ® 6800 System using the omni Utility Channel. Evaluation of the amplification curves and Ct values demonstrated that the enzyme included in the Opt kit is compatible with the unmodified primers and probes. Conclusions: This study demonstrates the transition of a manually- performed LDT to the fully automated cobas ® 6800 System. The cobas ® omni Utility Channel enables automation of LDT testing by utilizing the same platform, consumables and reagents as the FDA- approved IVD assays also performed on these systems. Presenter: Chris McGowin, PhD, Roche Diagnostics, Inc., Indianapolis, IN, Phone: 985.212.4261, Email: chris.mcgowin@ roche.com Clinical Laboratory Tests of Public Health Significance: What Is Really Necessary? (complete abstract in Quality Systems, p. 89) 80 LAB MATTERS Summer 2018 S. Abrams, Association of Public Health Laboratories, Silver Spring, MD Presenter: Samuel Abrams, Association of Public Health Laboratories, Silver Spring, MD, Phone: 240.485.2731, Email: samuel.abrams@aphl.org Improving Technologies for Biological Threat Detection T. Wolford and S. Abrams, Association of Public Health Laboratories, Silver Spring, MD The Laboratory Response Network for Biological Threats Preparedness (LRN-B) was formed in 1999 through a collaborative effort between the Centers for Disease Control and Prevention (CDC), the Federal Bureau of Investigation (FBI) and the Association of Public Health Laboratories (APHL). Originally comprising 17 laboratories, the LRN-B has since expanded membership to over 130 Federal, state and local governmental laboratories, international laboratories and sentinel clinical laboratories. Public health laboratories comprise 70% of the LRN reference level membership. A cornerstone of the LRN-B is its ability to rapidly and accurately detect biological threat agents. To that end, The LRN-B is continuously seeking the newest, most efficient and reliable technology for its testing needs. The network utilizes member laboratories to evaluate new technologies, ensuring buy-in from all parties and facilitates gathering input from labs with different PublicHealthLabs @APHL APHL.org