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:
[email protected]
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
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