Journal of Clinical Virology - Volume 82 - Supplement 1 - September 2016

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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142 S47
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Abstract no: 52
Presentation at ESCV 2016: Poster 52
Random access molecular diagnostics –
Increased efficiency in laboratory workflow and
translation of reduced result turnaround time
to patient benefit
G. Clark ∗, L. Anderson-Cable, M. Diggle
Nottingham University Hospitals NHS Trust, United
Kingdom
The advent of molecular diagnostics for infectious diseases was
accompanied by the ability to drastically reduce the time taken to
produce a diagnostic result, with tangible benefits to the patient
pathway such as rapid administration of treatment and timely
infection control intervention. However, the majority of molecu-
lar diagnostic platforms for the diagnosis of infectious disease are
reliant upon batch processing in order to maximise cost effective-
ness or due to limited availability of staff. This batch processing
workflow limits the possible reductions in result turnaround time
and thus potential benefits to the patient pathway.
The DxN VERIS System by Beckman Coulter is a random access,
real-time PCR analyser for the combined extraction and quanti-
tative analysis of pathogen nucleic acid in clinical samples. The
system is designed to reduce staff hands on time and enable real-
time testing of clinical samples. In order to evaluate potential
reductions in turnaround time to result, improvements in labora-
tory workflow and the opportunity to re-optimise the skill mix of
laboratory staff the DxN VERIS System was evaluated in parallel
with current testing methodologies at the Nottingham University
Hospitals Microbiology department. Of the four assays selected
for comparison (HIV, hepatitis B, hepatitis C and CMV quantita-
tion), significant reductions were demonstrated across all. Average
turnaround time reductions ranged from 36 h for CMV results, to
190 h for hepatitis B results and in most cases with VERIS analysis a
result would have been made available to the requesting clinician
on the same day as the sample request.
The issue of how result turnaround time directly affects the
patient is often not considered when evaluating a diagnostic plat-
form, but is becoming more important with recent initiatives to
implement timely and appropriate antimicrobial treatment and
necessary infection control precautions. The evaluation at Not-
tingham University Hospitals investigated this aspect further,
evaluating individual patient cases and demonstrating how a
reduction in turnaround time via random access testing could
directly translate to a positive impact on the patient care path-
way. Random access testing facilitates increased efficiency in the
patient’s care, timely intervention with appropriate antiviral ther-
apy and prompt decisions for future patient management.
Abstract no: 54
Presentation at ESCV 2016: Poster 53
Real-time multiplex PCR system detection of
viruses and bacteria in blood from febrile
infants <90 days of age
A. Hemmert ∗, B. Kensinger , E. Lo , J. Oblad ,
G. Storch , D. Schnadower , R. Selvarangan ,
F. Hassan , L. Heuschen , D. Thomas ,
K. Newcomer , J. Yi , R. Jerris , K. Stephens ,
A. Leber , D. Cohen , J. Daly , S. Holt ,
K. Bouzac , R. Crisp
1 BioFire Diagnostics, LLC, Salt Lake City, UT, USA
2 Washington University School of Medicine, St.
Louis, MO, USA
3 Children’s Mercy Hospital, Kansas City, MO, USA
4 Indiana University School of Medicine, IN, USA
5 Emory University School of Medicine, Atlanta, GA,
USA
6 Nationwide Children’s Hospital, Columbus, OH, USA
7 Primary Children’s Hospital, Salt Lake City, UT, USA
Background: Fever in infants (<90 days old) is a common med-
ical problem that accounts for a large proportion of pediatric
emergency department visits. Because the symptoms displayed are
often non-specific, it is difficult to distinguish between viral syn-
dromes, serious bacterial infection (SBI), or non-infectious causes of
fever. Clinicians currently rely on a combination of patient history,
physical examination, and laboratory findings to identify patients
that are at a high or low risk of SBI. While this methodology is
intended to reduce unnecessary testing/treatment, most febrile
infants still receive extensive evaluation as well as hospital admis-
sion until a bacterial infection can be ruled out. A rapid, easy-to-use,
comprehensive diagnostic test could benefit patient care in this
vulnerable population by potentially reducing antibiotic use or
influencing hospital admission decisions.
To aid in the etiological identification for this non-specific syn-
drome, BioFire Diagnostics is developing the FilmArray® Febrile
Infant (FI) Panel for use on the FilmArray System. The FilmArray
FI Panel simultaneously tests for six bacteria and ten viruses using
200 L of blood. Two minutes of hands-on time are required and
comprehensive results are returned in about an hour.
Materials and methods: 245 blood specimens from infants,
≤90 days, with either a fever (reported temperature > 38.0 ◦C) or
a blood/CSF culture where an SBI was suspected, were evaluated
in this study. This study was approved by each participating sites
institutional review board (IRB). Residual standard of care (SOC)
specimens as well as prospectively collected samples were tested.
Each blood sample was divided into two 250 L aliquots for Fil-
mArray FI testing and independent comparator PCR testing.
FilmArray FI results were compared to SOC laboratory results
as well as verified with independent PCR comparator assays. Any
discrepancies between the FilmArray FI Panel and comparator PCR
were investigated with additional bi-directional PCR sequencing.
Results: There were 80 detections of virus or bacteria, across
the 245 blood specimens (33% positivity). Seventy-nine percent
(79%, 63/80) were viruses and 21% were bacteria (17/80). The
most frequently detected virus was enterovirus (17), followed by
human herpesvirus 6 (16) and adenovirus (7). The most frequently
detected bacteria were Streptococcus agalactiae (6), Escherichia coli
(4), andStaphylococcus aureus (3). Blood culture identified 17 bacte-
ria, seven of which were common skin contaminants such as
Coagulase-negative Staphylococcus. FilmArray FI and blood culture
were in agreement of 4 of 8 shared results. Dual viral and bacterial
infections were observed in eight samples. The FilmArray FI Panel