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

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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142 S25
restrained within a particular batch, and gives a more challenging
sensitivity than that seen with internal controls. Monitored over
time and across different assay batches, these controls provide reas-
surance that the assay is as sensitive as it can be, which ultimately
leads to accurate and consistent patient diagnosis and treatment.
Inter and intra laboratory variation can lead to erroneous results.
It is recognised that a laboratory may achieve relatively consistent
results from run to run but there can still be differences between
operators, local equipment, pipetting technique and even calibra-
tion and training. Different methods exist to gather intra laboratory
data from complex excel sheets to hand written lab note books.
However it is harder and requires laboratory collaboration to gather
inter-lab data. This too should bemonitored overtime and if a devia-
tion is seen it is acted upon and investigated to maintain sensitivity
and accuracy. Similarly comparing one laboratories data against
another is insightful. With this information a laboratory can assess
why their data may differ from the consensus and investigate local
procedures to rectify such anomalies.
Many laboratories rely on EQA schemes to enable this compar-
ison, whilst an excellent way of comparing performance across a
large range of laboratories and assays, such schemes only provide
a periodic snap shot of performance.
The National Institute for Biological Standards and Control
(NIBSC) has developed a web-based Result Reporting System (RRS),
for the data monitoring of its serology and NAT quality control (QC)
reagents. Through the provision of Intra-lab charts and Inter box
plots. It allows real time intra and inter-laboratory comparison and
monitoring and by applying Westgard Rules to the data any devia-
tions from the norm are flagged, thus this software can provide an
early warning sign that a laboratories assay or equipment is failing.
Aided by a demonstration of RRS, this presentation will outline
the need for the use of external control material over solely using
internal controls andwill importantly highlight the necessarymon-
itoring needed in order to ensure reproducibility and consistency
of assay results.
Abstract no: 124
Presentation at ESCV 2016: Poster 8
CMV Run control r-gene® (ARGENE ® range,
bioMérieux): A tool to ensure the reliability of
human cytomegalovirus nucleic acid
amplification technique results
P. Marechal ∗, M. Dube , M. Bertrand ,
S. Grosz , F. Meynier , C. Barranger ,
M. Joannes
1 bioMérieux, 138 rue Louis Pasteur, Parc
Technologique Delta sud, 09340 Verniolle, France
2 bioMérieux, Centre Christophe Mérieux, 5 rue des
Berges, Grenoble, France
The primary aim of any laboratory is the timely delivery of reli-
able results with a minimum of errors, maintaining confidence in
the results for all stakeholders. The use of independent quality con-
trol (IQC) provides constant and consistent monitoring of an assay
results in a systematic manner so that variation in the assay system
can be monitored over time (day-to-day test variation, lot-to-lot
performance of test kits, operator variation, etc.). An IQC material
must be robust, stable and well characterized. Its properties should
be as close as practically possible to patient specimens and should
be processed throughout the analysis in the sameway as the clinical
sample.bioMérieux has developed an IQC named CMV Run Control
r-gene® (ARGENE® range)*. Its routine use enables monitoring run
to run performance for human cytomegalovirus nucleic acid ampli-
fication technique (NAT) assays for human clinical samples. CMV
Run Control r-gene® is intended for health care professional and
for in vitro use only.
This CMV Run Control r-gene® (ARGENE® range) consists in
a non-inactivated whole CMV strain (AD169) spiked in pooled
human plasma tested negative for CMV, HIV, HCV, HBV, Parvo-
virus B19, and EBV. This formulation allows to mimic naturally
occurring specimens containing CMV DNA. The CMV Run Control
r-gene® (ARGENE® range) has no assigned concentration value but
it is defined in order to be within the dynamic range of most molec-
ular assays. This control should therefore be validated for use as a
run control and the expected results determined by the end user for
their particular CMV NAT assay, extraction and instrument combi-
nation.
Performance results obtained in-house (precision and stability
studies) of CMV Run control r-gene® (ARGENE® range) established
with the CMV R-gene® kit (ARGENE® range, bioMérieux) on the
platform combination NucliSENS® easyMAG® (bioMérieux)/ABI
7500 Fast (Life TechnologiesTM) will be presented.
* Not yet commercialized.
Abstract no: 126
Presentation at ESCV 2016: Poster 9
RNA internal control, a new tool for the rapid
development of detection tools by real time PCR
in outbreak situation. Application to the
detection of Middle East Respiratory Syndrome
human coronavirus
C. Barranger ∗, P. Marechal , M. Bertrand ,
M. Dube , D. Heckel , M. Joannes
1 Molecular Diagnostics Europe, bioMérieux S.A.,
Verniolle, France
2 Molecular Diagnostics Europe, bioMérieux S.A.,
Grenoble, France
Since the emergence of Middle East Respiratory Syndrome
Coronavirus (MERS-CoV) in 2012 in the Arabian Peninsula, many
questions remain unanswered onmodes of transmission and reser-
voirs of virus. The MERS-CoV causes severe respiratory illness. The
epidemic origins are uncertain but probably linked to a zoono-
sis. The bat or the camel are discussed as reservoirs of the virus.
Globally, since September 2012, WHO has been notified of 1,714
laboratory-confirmed cases of infection with MERS-CoV, including
at least 618 related deaths (WHO report – 14 April 2016).
In such outbreak situations, especiallywith emerging organisms
causing severe human diseases, it is important to quickly develop
a test for the detection the virus involved.bioMérieux developed
a generic kit, RNA internal control r-gene® (bioMerieux), combin-
ing an internal control and a core kit to be used in combination
with either proprietary or commercial primers and probes. This tool
associated with specific primers and probes constitute a ready-to-
use duplex premix for the detection of targeted RNA in a sample.
On this principle, bioMérieux developed a real-time PCR assay
for the rapid detection of MERS-CoV. A set of primers and probe and
a transcript used as positive control (MERS-HCoV primers r-gene®
– RUO #20-010 and MERS-HCoV probe r-gene® – RUO #20-011,
MERS-HCoV transcript – RUO #68-010, bioMérieux) were designed
on the S gene, coding for the spike structural protein.
The internal control, added before the extraction step, allows
to check simultaneously extraction efficiency and presence of
inhibitors. Extractions were performed on NucliSENS® easyMAG ®