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

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S84 Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
Overall prevalence of HCV RNA positivity was 0.93%, 1.5% in males
and 0.39% in females. Of all examined subjects 47 were i.v. drug
users, 51.06% of them were anti-HCV positive, 23.4% HCV RNA
positive. 0.88% of anti-HCV positivity was in the rest of examined
subjects (non-drug users) with 0.58% of HCV RNA positivity. HCV
genotypes were determined: 1a in 25%, 1b in 25%, 3a in 46% (4%
nondetermined).
Conclusion: Since 2001 HCV seroprevalence has increased
eightfold up to 1.67% with higher prevalence in males and in drug
users. Highest HCV seroprevalence and chronic VHC was deter-
mined in males in age group of 30–44 years. with the increase of 3a
genotype (31.1% vs 46%). Recounted to the total number of inhabi-
tants we can estimate there are more than 140,000 persons with
VHC anamnesis and more than 80,000 persons living with chronic
hepatitis C in the Czech Republic.
The study was supported by research grants of Gilead Sciences
and Long TermOrganization Development Plan 1011, University of
Defence.
Abstract no: 7
Presentation at ESCV 2016: Poster 127
The Syrian refugees crisis brings challenges to
the health authorities in Europe: Hepatitis A
Virus is a case in point
S. Ramia ∗, K. Kreidieh, N. Melhem
American University of Beirut, Lebanon
The ongoing three-year Syrian Civil war has left hundreds of
thousands killed or wounded in addition to the displacement of
more than 6.5 million Syrians throughout the world. According
to the United Nations High Commission on Refugees (UNHCR),
10% of the displaced Syrian refugees are seeking safety in Europe
where themajorities are concentrated in Serbia and Germany (57%)
compared to 31% in Sweden, Hungary, Austria, Netherlands and
Bulgaria, and 12% in the remaining 37 European Countries. This
influx of Syrian refugees to Europe presents the European health
authoritieswith a serious challenge as it carrieswith it the potential
of introducing infectious diseases that have been eradicated in the
continent. These diseases include poliomyelitis, measles, to men-
tion only a few. In contrast to the vaccine coverage against polio
and measles in Europe, the overwhelming majority of European
countries do not include HAV vaccine in their immunization calen-
dars. Moreover, the incidence rates of HAV infection in European
countries has declined since themid-1990s to very low levelswhich
put susceptible populations at risk of acquiring HAV infection and
therefore the greater likelihood of outbreaks in these countries.
Consequently, there is a growing public health concern in high-
income countries, like most of the European countries, that many
adults remain susceptible to HAV infection and are thus at risk of
severe HAV symptoms and may be death. The impact/spread of
HAV outbreaks among refugees on the hosting European countries
is expected as was the case in other hosting countries such as
Lebanon, Jordan and Iraq. We believe that new policies regarding
HAV vaccination should be implemented in the European countries.
Since Western Europe, where most of the Syrian refugees are con-
centrated, has consistently shown a very low seroprevalence rate
of anti-HAV compared to low seroprevalence rates in Central and
Easter Europe, perhaps large-scale immunization programs among
children more than one year of age in East European countries
and vaccination campaigns targeting high-risk groups in the West-
European Countries are practical approaches at the present time.
This article sheds the light on an immediate action that has to be
taken by the European countries in order to control HAV infection
and to prevent any future HAV epidemics in the continent.
Abstract no: 89
Presentation at ESCV 2016: Poster 128
Performance of the Aptima® HCV Quant Dx
Assay on the Panther® System
Andrew Worlock ∗, Trisha Le-Nguyen, Chau Ly,
Candace Motta, Catherine Nguyen,
Jimmykim Pham, Analee Williams, Marilyn Vi,
Bryan Vinluan
Hologic, 10210 Genetic Center Drive, San Diego, CA
92121, USA
Background: The Aptima HCV Quant Dx Assay is a fully auto-
mated quantitative assay for use on the Panther® system. It is based
on real-time Transcription-Mediated Amplification (TMA) technol-
ogy. The assay measures and quantifies HCV in serum and plasma
samples. It can be used an aid in the diagnosis of HCV infection
and in the management of HCV infected patients undergoing HCV
antiviral drug therapy.
Methods: The Lower Limit of Detection (LoD) and Lower Limit
of Quantitation (LLOQ) of the assay were determined from dilu-
tions of the 2nd HCV WHO International Standard (NIBSC 96/798
genotype 1) and HCV positive clinical specimens diluted in HCV
negative human plasma and serum. Probit analysis was performed
to generate the 95% predicted detection limits. LLOQ was estab-
lished for each genotype by diluting clinical specimens and the
2nd HCV WHO International Standard (NIBSC 96/798 genotype 1)
in HCV negative human plasma and serum following CLSI EP17-
A guidelines. Specificity was determined using 200 fresh and 536
frozen HCV RNA negative clinical specimens including 370 plasma
specimens and 366 serum specimens. Linearity for genotypes 1–6
was demonstrated by diluting HCV transcript in buffer at concen-
trations ranging from 1.36 to 7.36 log IU/mL. Precision was tested
using a 10 member panel made by diluting HCV positive clinical
specimens or spiking armored RNA into HCV negative plasma and
serum. A method comparison was conducted against the Abbott
RealTime HCV Assay using 1058 (872 plasma, 186 serum) clinical
specimens from HCV infected patients.
Results: The 95% LoD was dependent on the HCV genotype and
was 5.1 IU/mL or lower for serumand 4.8 IU/mL or lower for plasma.
The LLOQ for the assay was 10 IU/mL for both serum and plasma.
Specificity was 100% with 95% confidence intervals of 99.6–100%
for serumand plasma data combined. The assay demonstrated good
linearity across the dynamic range for all genotypes. Precision was
0.17 log SD or lower across the range of the assay for both serum
and plasma. Aptima HCV Quant Dx assay viral load results for clin-
ical specimens were compared to those obtained using the Abbott
RealTime HCV Assay. A slope of 1.07, an intercept of 0.08 and an R 2
of 0.97 were obtained.
Conclusion: The Aptima HCV Quant Dx Assay is highly sensitive
and specific. The assay gave comparableHCVviral load resultswhen
compared to the Abbott RealTime HCV Assay. The performance of
the Aptima assay makes it an excellent candidate as an aid in the
diagnosis of HCV infection and in the management of HCV infected
patients undergoing HCV antiviral drug therapy.