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

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S32 Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
strates the Aptima HCV Quant DX Assay is suitable for use across all
genotypes with serum or plasma in clinical laboratory algorithms.
Abstract no: 171
Presentation at ESCV 2016: Poster 22
The modular approach to respiratory
syndromic testing with the fully-automated
novel Panther Fusion System
M. Jost ∗, A. Shah, P. Douglas, C. Hentzen,
T. Nugent, D. Kolk
Hologic Inc., San Diego, CA USA
Background: Respiratory viral infections remain a leading cause
of infectious diseases worldwide. Because most respiratory viruses
present with similar symptoms, molecular diagnostic tools are
required for rapid and accurate diagnosis to ensure appropriate
patient management. Current diagnostic techniques include insen-
sitive rapid tests, costly mega-panels, or complicated work-flow
involving multiple assays. Furthermore, current methods are only
approved for the diagnosis of upper respiratory tract (URT) infec-
tions but not lower respiratory tract (LRT) infections. Misdiagnosis
of LRT infections of viral origin has led to overtreatment with antibi-
otics and increased levels of multi-drug resistance.
The Panther Fusion System and respiratory panels (IVD assays
in development) address the clinical need for a flexible, modu-
lar approach to syndromic testing. The Panther Fusion Respiratory
panels are qualitative multiplex RT-PCR assays which detect and
differentiate multiple targets utilizing assay specific reaction mix-
tures. Panther Fusion offers random access capability, minimum
sample handling, and short sample in-to-first result processing to
identify Influenza A and B (Flu A/B), Respiratory Syncytial Virus
(RSV), Parainfluenza virus 1, 2, 3, 4 (Paraflu), Adenovirus (AdV),
human Metapneumovirus (hMPV), and Rhinovirus (RV). The three
respiratory panels can be run from a single nasopharyngeal swab
(NP) or LRT specimen (bronchoalveolar lavages, BAL; bronchial
washes, BW). This study describes preliminary performance of
the Panther Fusion Respiratory panels for analytical sensitivity,
inclusivity, cross-reactivity, reliability in co-infection, and clinical
performance.
Methods: The analytical sensitivity panel was generated by
spiking viral transport medium (VTM) with various viral isolates for
each target at known TCID50 concentrations. The specificity panel
was generated by spiking potential cross-reacting microorganisms
into VTM at clinically relevant concentrations. For competitive
interference in co-infections, viral isolates were spiked at low
(0.5 log > LoD) and high (3 log > LoD) concentrations in simulated
clinical matrix (SCM). Clinical performance of each viral target was
compared to various on-market assays.
Results: The analytical sensitivity of the Panther Fusion assays
was 10 −2–102 TCID50 depending on strain or serotype tested.
LoDs for all three specimen types were within 0.5 log for all
strains tested. No cross-reactivity between other common viruses
or micro-organisms was observed. Percent agreement in repro-
ducibility studies for all intended targets was 100%. Time-to-first
result was less than 2.5 h. Concordance of clinical performance to
on-market assays was high with positive and negative agreements
of 93.5–100% and 96.0–100%, respectively, for all intended targets
in all three assays.
Conclusions: Based on preliminary sensitivity, specificity, and
clinical comparison studies, the Panther Fusion Systemand Panther
Fusion Respiratory Panels (A/B/RSV, Paraflu, AdV/hMPV/RV) offer
an unmatched combination of flexibility, throughput, and automa-
tion for respiratory viral testing in both upper and lower respiratory
tract specimens.
Abstract no: 176
Presentation at ESCV 2016: Poster 23
Performance evaluation between Seegene
Anyplex II RV16 Version 1.1 and Biofire
FilmArray Respiratory Panel Version 1.7 for the
detection of respiratory viruses
Eileen S.M. Goh∗, K.S. Chan, B.K. Peh, E.X. Yau,
P.Z. Ong, Lynette L.E. Oon
Department of Pathology, Singapore General
Hospital, Singapore
Background: Respiratory viral infections can cause serious
complications in children, elderly and immunocompromised indi-
viduals. Rapid and precise identification of respiratory pathogens
is thus critical for administering the appropriate antiviral ther-
apy, clinical management and timely infection control measures.
Recent developments in multiplex real-time polymerase chain
reaction (PCR) allow for detection of multiple respiratory viruses
with increased sensitivity and shorter turnaround time. Many such
kit assays are currently commercially available for use in diag-
nostic laboratories. In this study, we evaluated the performance
of two commercial assays, the Seegene Anyplex TM II RV16 and
the BioMérieux BioFire RP Panel. AnyplexTM II RV16 Detection
v1.1 (RV16; Seegene) is a multiplex real-time PCR using Tagging
Oligonucleotide Cleavage and Extension (TOCE) technology that
detects 16 respiratory viruses. The Food and Drug Administra-
tion (FDA)-cleared BioFire FilmArray ® Respiratory Panel (Biofire
RP Panel; BioMérieux) integrates sample preparation, amplifica-
tion, detection and analysis into one simple system that requires
minimal hands-on time with a total run time of around one hour.
It detects 17 viruses and 3 bacteria, and has a throughput on one
sample per instrument.
Methods: This study was done in two stages, retrospective and
prospective, on a total of 145 specimens. For the retrospective
study, 68 archived positive patient samples including bronchoal-
veolar lavage, nasopharyngeal swab, nasopharyngeal aspirate and
sputum, which were previously characterized by the RV16 assay,
were further tested on Biofire RP Panel according to the manu-
facturer’s instructions. 22 archived CAP external quality assurance
(EQA) respiratory viral specimens (2014–2015) were also ran on
both assay platforms. These archived samples were stored at
−80 ◦ C before testing. Specimens with discordant results were
re-extracted and re-run on the RV16 assay to rule out sample degra-
dation. For the prospective study, 55 recently collected samples
were simultaneously ran on both platforms. To resolve discordant
results for influenza A/B, for which specific anti-viral treatment is
available, an in-house developed PCR assay for influenza was used.
Results: The overall agreement between the two methods was
high at 89% (2064/2320), calculated based on 16 viral targets.
Taking RV16 as the gold standard, the overall sensitivity and speci-
ficity of Biofire RP panel was 87.2% and 97.2% respectively (95%
confidence intervals, 79.1–92.5%). Biofire RP Panel appeared to
be less sensitive for influenza B, adenovirus, parainfluenza 4, rhi-
novirus, enterovirus andmetapneumovirus compared to RV16. The
in-house developed assay for influenza further confirmed two dis-
cordant results of influenza B in favor of the RV16 assay. The results
for 22 archived positive CAP EQA respiratory viral specimens were
fully concordant between the two assays.