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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142

S33

Conclusions:

In our study, Seegene RV16 demonstrated higher

sensitivity than Biofire RP Panel. Although Biofire RP Panel is sim-

pler to run, allows for random access and comes with a shorter

turnaround time, its capacity for high-throughput testing would

be limited by the number of instruments available. Contrastingly,

RV16 requires less effort using batch testing, which is suitable for

outbreak situations when there is large influx of patient samples.

http://dx.doi.org/10.1016/j.jcv.2016.08.063

Abstract no: 185

Presentation at ESCV 2016: Poster 24

Performance comparison of the new filmarray

meningitis/encephalitis panel with routine

diagnostic methods

Nicole von Allmen

1 ,

, A

nke Edelmann

2 ,

Sebastian Kuehn

1

1

Labor Berlin – Charite Vivantes Services GmbH,

Germany

2

Labor Berlin – Charite Vivantes GmbH, Germany

Background:

Meningitis is the inflammatory disease of mem-

branes that surround the brain and spinal cord. The inflammation of

the brain itself is known as encephalitis. Viruses, bacteria, fungi or

parasites may cause these life-threatening infections. In particular,

young, elderly and immunocompromised persons are of increased

risk. The incidence of acute encephalitis in Western countries is

7.4 cases per 100,000 population per year. For effective patient

management and to minimize morbidity and mortality, prompt

diagnosis is crucial.

The objective of this study was to evaluate the application of

the Film Array (FA) Meningitis/Encephalitis panel (ME) for clini-

cal diagnostics. Retrospective and prospective cerebrospinal fluid

(CSF) clinical samples were tested in comparison with the methods

routinely applied in our laboratory for the testing of pathogens in

CSF specimens.

Material and methods:

Residual CSF samples from patients

with a high suspicion of a meningitis/encephalitis infection were

included in this study. All samples were tested beforehand (stored

frozen at

20

C) or in parallel with the validated routine labora-

tory methods which were considered to be the reference methods

(viruses: in-house real-time PCR; bacteria: conventional culture

and MALDI-TOF). For this method validation, 200 l CSF resid-

ual sample volume was tested with the FA ME panel. FA is an

automated highly multiplexed closed PCR platform/system that

detects 6 bacteria:

Escherichia coli K1, Haemophilus influenzae, Lis-

teriamonocytogenes, Neisseriameningitidis, Streptococcus agalactiae,

Streptococcus pneumoniae

, 7 viruses: cytomegalovirus, enterovirus,

herpes simplex type 1, herpes simplex type 2, human herpesvirus

6, human parechovirus, varicella zoster virus, 2 fungi: Cryptococcus

neoformans/gattii.

Results:

A total of 191 CSF specimens were tested. Initially, 178

FA ME results (93.2%) were consistent with the results of the ref-

erence methods. 9 of the 13 CSF specimens with discrepant results

had to be excluded from the final statistical analysis since no mate-

rial was left for confirmation testing. From these 13 discrepant

results, 7 were prospective and 6 retrospective specimens. Only in

four cases confirmation testing could be performed. Nevertheless,

the analyzed data showed a final concordance between the refer-

ence methods and FA ME of 99.4%. Pathogens detected included:

Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalac-

tiae, Streptococcus pneumoniae

, enterovirus, herpes simplex type 1

and 2, human herpesvirus 6, varicella zoster virus and Cryptococcus

neoformans/gatti.

Conclusions:

Based on the results acquired in this study, the

FA ME panel is of great value for the management of menin-

gitis/encephalitis suspected cases where a comprehensive (14

pathogens) and fast response (in approximately 1 h) may help pre-

vent secondary complications or evenmake a life-saving difference.

This is particularly true for bacterial infections where an immi-

nent antibiotic therapy is crucial for the whole recovery of the

patient. As the clinical symptoms of a bacterial and viral infection

for meningitis and encephalitis are often overlapping, the correct

clinical diagnosis is not obvious. For the most common infectious

pathogens included in the panel, this dilemma is solved by the use

of FA ME.

http://dx.doi.org/10.1016/j.jcv.2016.08.064

Abstract no: 192

Presentation at ESCV 2016: Poster 25

The novel ARIES platform demonstrates

simplified molecular workflows and enhanced

lab efficiency

Shuba Das

1 ,

, Frank Simons

2

, Ricardo Perez

1

,

Allen Ward

1

, Sherry Dunbar

1

1

Luminex Corporation, United States

2

Luminex B.V., United States

Background:

Diagnostic laboratories are continuously looking

for ways to maximize productivity, improve workflow, optimize

staff time, and reduce the time to deliver results back to health-

care providers. In addition, there is a desire to shift from traditional

testing methods to faster, more sensitive, and more cost-effective

molecular methods. In this study, a time andmotion studywas con-

ducted using Luminex ARIES system. ARIES is an automated, sample

to answer platform that fully integrates extraction of nucleic acid

from clinical samples, real-time PCR detection, data analysis, and

results reporting.

Material/methods

: In this study the Xpert GBS LB and ARIES

HSV 1&2 assays were used as the Xpert GBS LB assay does not

require any pre-processing steps and is most similar to ARIES

workflow. The goal of this study was to compared hands-on time

for ARIES and Cepheid GeneXpert systems, including hands-on

time required to set up various numbers of samples, data entry,

patient/sample information entry, and then starting the run for

both systems. Two different scenarios were assessed for ARIES –

(i) entering test order, sample, and assay information at the instru-

ment using the barcode reader provided (standard workflow), and

(ii) sample and cassette scanned in advance and sent to ARIES by

LIS (LIS-enabled).

Results:

The average time needed to load one sample was 52 s

for GeneXpert and 71 s and 34 s for ARIES in standard workflow and

LIS-enabled mode, respectively. For 16 samples, GeneXpert took

10min 10 s while ARIES required 9min 52 s (standard workflow)

and 4min 58 s (LIS-enabled mode). The reduction in hands-on time

was very explicit when ARIES was configured in the LIS-enabled

mode (no additional manual scanning required). A reduction in

hands-on time of 45% was observed when loading 12 samples into

ARIES in LIS-enabled mode as compared to GeneXpert.

Conclusions:

In this time and motion study, we found that on

average the set up time favored ARIES as compared to GeneXpert

as less hands-on time and fewer user interactions were required.

This was most pronounced if the number of samples approached

six as setting up a run for a single sample was 19 s faster on GeneX-

pert. In general, ARIES showed reduced hands-on time, enhanced