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

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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142 S77
Portuguese population. We also aimed to search for recent HEV
infection in slaughterhouse workers. This study was funded by EEA
grants and is part of HEPeCONTROL project (60DT2).
Materials and methods: A case–control study was conducted
among swine slaughterhouse workers in Portugal. Serum samples
(n = 114) were collected from swine workers of slaughterhouses
of the North and Centre of Portugal between September and
November 2015. Sera (n = 804) from the general population
matched by age, gender and region, obtained from anonymous vol-
unteers were used as controls. All samples were tested for anti-HEV
IgG and IgM antibodies by an enzyme immunoassay (recomWell
HEV IgG/IgM version 2015, Mikrogen, Germany) and retested by
immunodot assay (recomLine HEV IgG/IgM version 2015, Mikro-
gen, Germany) if positive for anti-HEV IgM. A chi-square test for
homogeneity of proportions was used to determine significant dif-
ferences in anti-HEV prevalence between study groups.
Results: Anti-HEV IgG was found in 30.7% (35/114) of workers
and in 19.9% (160/804) of general population. Differences between
these two groups showed to be statistically significant (p < 0.05).
Two workers presented only anti-HEV IgM without anti-HEV IgG
suggesting recent HEV infection.
Discussion: The results obtained in this study showed that
Portuguese swine slaughterhouses workers have higher HEV
seroprevalence than the general population. Therefore, these pro-
fessionals should be considered a specific risk group for HEV
infection and hygienemeasures are highly recommended to reduce
their exposition to HEV. This study is the first in Portugal focusing
on the occupational risk of swine workers of slaughterhouses.
Abstract no: 295
Presentation at ESCV 2016: Poster 113
Clinical and analytical performance
characteristics of the VERSANT HCV RNA 2.0
(kPCR) assay
A.J. Chmura ∗, Stacie Ho, Jesse Brooks,
Paula Swiatkowski, Lainia Magaya, Carlo Cosenza,
Jennifer Johnson, Joern Mosner
Siemens Healthcare Diagnostics, Germany
Hepatitis C viral (HCV) RNA detection and quantitation are
of central importance for confirmatory diagnosis and monitor-
ing of chronically-infected HCV patients after infection and while
undergoing treatment. The new VERSANT® HCV RNA 2.0 (kPCR)
Assay* has been designed to support both of these applications
simultaneously on a single assay platform. Utilizing a dual tar-
get/dual amplicon assay design, the assay is intended to achieve
good sensitivity, specificity and standardization across diverse HCV
genotypes. The objective of this study is to assess the analytical
performance of the new VERSANT HCV RNA 2.0 (kPCR) Assay, and
to compare its quantitative performance to current CE-IVD HCV
viral load assays with clinical samples across all six major HCV
genotypes.
Analytical performance testing of the VERSANT HCV RNA 2.0
(kPCR) assay evaluated sensitivity, specificity, linearity, precision,
and accuracy. Linearity was also evaluated across each HCV geno-
type (1a, 1b, 2a, 2b, 3, 4, 5, 6). The estimated limit of detection
(PROBIT) was 7.44 IU/mLwith a 95% CI of 5.4–10.23 IU/mL in plasma
and 8.84 IU/mL with 95% CI of 6.6–11.74 IU/mL in serum. Linearity
was evaluated across the test range (22–1,100,000 IU/mL) in both
serum and plasma. The log difference between the mean quanti-
tated value and the linearized quantitated value is within 0.12 log.
The calculated between lot %CV was less than 30 for both matri-
ces across the linear range. Likewise, the observed accuracy was
within 0.2 log of the target concentration. The VERSANT HCV RNA
2.0 (kPCR) assay exhibited a specificity of 100% in both matrices.
Linearity was evaluated over a range of 10–1,000,000 IU/mL for all
major HCV genotypes. The log difference between the mean quan-
titated value and the linearized quantitated value over this range
is within ±0.05 log.
A total of 236 HCV-positive samples across genotypes 1–6
were tested for viral load determination with the VERSANT HCV
RNA 2.0 (kPCR) Assay and two widely-used comparator assays.
Samples were evenly distributed across the common HCV geno-
types/subtypes (1a: 16; 1b: 14; 2: 9; 2a-c: 11; 2b: 25; 3: 48; 4:
33; 5: 47; 6: 33). Results from the VERSANT HCV RNA 2.0 (kPCR)
Assaywere compared using statistical methods withmatched sam-
ple test results from the Abbott Real-Time HCV Assay and the Roche
CAP/CTM 2.0 Assay. Overall, the average log difference was 0.18
log when comparing the VERSANT HCV RNA 2.0 (kPCR) Assay and
Abbott Real-Time HCV Assay, and −0.24 log when comparing the
VERSANT HCV RNA 2.0 (kPCR) Assay and Roche CAP/CTM2.0 Assay.
When evaluated on a per genotype basis, the new VERSANT HCV
RNA 2.0 (kPCR) Assay testing results consistently laid between
the comparator methods, demonstrating how the Siemens assay
is well standardized with resulting quantitation between the rel-
ative quantitation extremes of the Roche CAP/CTM 2.0 Assay and
the Abbott Real-Time HCV Assay.
Overall these performance characteristics suggest the newVER-
SANTHCVRNA2.0 (kPCR) Assay as a favorable alternative to current
HCV viral load assays.
*VERSANT HCV RNA 2.0 (kPCR) Assay under feasibility evalua-
tion. Not for sale and its future availability cannot be guaranteed.
VERSANT and all associated marks are trademarks of Siemens
Healthcare Diagnostics Inc. All other trademarks and brands are
the property of their respective owners. Product availability varies
by country. © 2016 Siemens Healthcare Diagnostics Inc. All rights
reserved.
Abstract no: 296
Presentation at ESCV 2016: Poster 114
Hepatitis A and E among asymptomatic
pregnant women and acute hepatitis patients
from South Tunisia
Houcine Neffati ∗, Patricia Lebraud ,
Corinne Hottelet , Anne-Marie Roque-Afonso
1 APHP, Paul Brousse Hospital, National Reference
Centre for HAV, France
2 APHP, Paul Brousse Hospital, Virology, France
Background: Hepatitis A and E viruses (HAV and HEV) are both
non enveloped viruses responsible for enterically transmitted hep-
atitis. Tunisia is reported to be a country of intermediate endemicity
for HAV (≥ 50% have immunity by age 15) nd of low sero-
prevalence for HEV (<10%) he aim of this study was to assess
hepatitis A and E markers among asymptomatic pregnant women
and patients with acute hepatitis in rural areas of South Tunisia.
Methods:Sera from216 asymptomatic pregnantwomenunder-
going routine gynecological screening and from 92 patients
with acute hepatitis were collected between October 2014
and November 2015 from the hospitals in Gabes, Medenine
and Tatouine town in South Tunisia. Total and IgM anti-HAV
immunoglobulins and anti-HEV IgG and IgM were investigated.
HAV IgM positive samples were subjected to in house RT-PCR tar-
geting 500 nt of the VP1/2A region and sequenced. Anti-HAV IgG