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

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Abstracts / Journal of Clinical Virology 82S (2016) S1–S142 S87
Abstract no: 141
Presentation at ESCV 2016: Poster 133
Prospective evaluation of Cepheid Xpert HIV-1
Viral Load assay as a supplemental
confirmatory HIV-1 test in the routine clinical
laboratory setting
K. Fujs Komloˇs ∗, P. Markocic, B. Kuˇsar, L. Hoˇsnjak,
T. ˇStamol, M. Poljak
Institute of Microbiology and Immunology, Faculty of
Medicine, University of Ljubljana, Ljubljana, Slovenia
Background: Confirmation of HIV infection is a multistage
procedure – in the case of reactive/indeterminate results of the
4th generation screening immunoassay, serum/plasma samples
are tested with a confirmatory antibody assay that differentiates
between HIV-1 and HIV-2. Recently it was recommended to resolve
nonreactive/indeterminate results of an anti-HIV confirmatory test
with a HIV-1 nucleic acid amplification test. The Cepheid Xpert HIV-
1 Viral Load (Xpert) is an in vitro diagnostic test designed for rapid
quantification of HIV-1 in human plasma and prediction of dis-
ease prognosis, taking into account the clinical presentation and
results from other tests. To the best of our knowledge, to date the
performance of the Xpert on human serum samples has not been
evaluated. The objective of the present study was to prospectively
evaluate whether the Xpert can be used off label as a rapid sup-
plemental assay for the same day confirmation of HIV-1 infection
and/or rapid resolution of HIV status in either serum or plasma
sampleswith reactive/indeterminate HIV screening test results and
indeterminate/negative HIV confirmatory test results.
Materials and methods: The present study included 67
prospectively collected blood samples from 50 consecutive anti-
HIV-1-positive individuals with clearly positive results of the
confirmatory Geenius HIV-1/2 assay (Geenius) in the initial
specimen and from 17 consecutive individuals with initially
unresolved HIV-1 status (reactive/indeterminate screening and
negative/indeterminate confirmatory Geenius results), out of
whom 15 turned to be HIV negative in the follow-up and 2 had
acute HIV-1 infection at the time of initial testing. The presence of
HIV-1 RNA in all initial samples (27 serum and 40 plasma samples)
was determined using Xpert, following the manufacturer’s instruc-
tions, and compared to the results obtained with Abbott RealTime
HIV-1 (Abbott RT).
Results: The presence of HIV-1 RNA was detected using both
Xpert and Abbott RT in initial blood samples of all 50 individuals
with clearly positive confirmatory Geenius results in initial speci-
mens and in both individuals with initially unresolvedHIV-1 status,
who had acute HIV-1 infection at the time of initial testing. All 15
individuals with initially unresolved HIV-1 status, who turned to be
HIV negative in the follow-up, tested HIV-1 RNA negative in initial
blood samples using both Xpert and Abbott RT. In 17 HIV-1-positive
serum samples viral loads ranged from 3.33 to >7 log10 cp/ml
(mean 4.66 log10 cp/ml) and from 2.45 to >7 log10 cp/ml (mean
4.37 log10 cp/ml) using Xpert and Abbott RT, respectively, demon-
strating a good correlation between the two tests (Pearson r = 0.98,
R2 = 0.93), with an overall mean difference of 0.29 log10 cp/ml
(range −0.1 to 0.87). In 35HIV-1 positive plasma samples viral loads
ranged from 1.75 to 6.53 log10 cp/mL (mean 5.07 log10 cp/ml) using
Xpert and from <1.6 to = “” 6 = “” 51 = “” log = “” sub = “” > 10 cp/mL
(mean 4.84 log10 cp/ml) using Abbott RT, demonstrating a good cor-
relation between the two tests (Pearson r = 0.96, R2 = 0.92), with an
overall mean difference of 0.23 log10 cp/ml (range −0.5 to 0.8).
Conclusions: According to results of the present study Xpert
can be used as a reliable supplemental molecular test for rapid
confirmation of HIV-1 infection and/or resolution of HIV status in
either serum or plasma samples with reactive/indeterminate HIV
screening test results and indeterminate/negative HIV confirma-
tory test results.
Abstract no: 17
Presentation at ESCV 2016: Poster 134
Molecular characterization of HIV-1 in
HBV± HDV/HCV co-infected HIV-1 positive
patients in Turkey
Murat Sayan ∗ ila Akhan ma Sargin
Kadriye Yasar , Atahan Cagatay , Dilara Inan ,
Funda Simsek en Kaptan
Aysel Kocagul Celikbas , Hayati Demiraslan
1 Kocaeli University, Medical Faculty PCR Unit,
Turkey
2 Kocaeli University, Medical Faculty (presenting
author), Turkey
3 Medeniyet University, Goztepe Educational and
Research Hospital, Turkey
4 Bakırköy Sadi Konuk Hospital, Turkey
5 Istanbul University, Medical Faculty, Turkey
6 Akdeniz University, Medical Faculty, Turkey
7 Istanbul Okmeydani Hospital, Turkey
8 Katip C¸ elebi University, Turkey
9 Ankara Numune Hospital, Turkey
10 Erciyes University, Medical Faculty, Turkey
Background and aims: Co-infection with either HBV ±HDV or
HCV in HIV-1 positive patients is not very common, but possible
since all these viruses share transmission routes and geographical
distribution. Interaction between these viruses generally ampli-
fies liver damage, increasing the risk of developing end-stage
liver disease and hepatocellular carcinoma. HIV/HCV co-infection
is associated with poorer response to antiviral therapy. The objec-
tives of this study were to determine the subtypes and the primary
ART resistance mutations of HIV-1 in HBV± HDV/HCV co-infected
HIV-1 positive Turkish patients.
Materials and methods: We have 74 co-infections from eleven
different province of Turkey [Gender, M/F n ; 65/9, Age, median
years (range); 39 (17–68), CD4+ T-cell count, median mm3 (range);
389 (3–1659), HIV-RNA load, median IU/ml (range); 5.62 + E5
(6.9 + E2–6.3 + E6), HIV acquisition route, n (%); heterosexual con-
tact; 38 (51), MSM; 30 (41), Bisexual contact; 2 (2.7), Injection drug
use; 4 (5.3), Co-infection status, n (%); HIV-1 +HBV; 56 (76), HIV-
1 +HBV +HDV; 3 (4), HIV-1 +HCV; 15 (20)]. HIV-1 subtypes and
CRFs were identified by phylogenetic analysis (neighbor – joining
method) via sequencing of HIV-1 pol gene (CLC Sequence Viewer
v7.5, Qiagen Aarhus A/S, Denmark). HIV-1 ART resistance muta-
tions were analyzed according to criteria by the WHO 2009 list of
surveillance drug resistance mutations.
Results: The molecular evidence in this study indicates subtype
B (51/74, 69%) and CRFs (17/74, 23%) of HIV-1 are most preva-
lent subtypes. CRFs of HIV-1, that are described in HBV ±HDV and
HCV co-infected patients mainly caused from South-East Asia, East
Asia and Central Africa (CRF 01 AE), West Africa, Central Africa and
Middle East/North Africa (MENA) (CRF 02 AG), South America (CRF
12 BF) and Spain (CRF 14 BG), respectively. HIV-1 ART resistance
mutations were detected in 12/59 (20%) and 3/15 (20%) HBV ± HDV
and HCV co-infected patients in HIV-1 positive Turkish patients,
respectively. However, genotype D/subtype D1(98%) in HBV and
type 1b (93%) inHCV infected patientswere predominant genotype.