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

40 / 152

S36 Abstracts / Journal of Clinical Virology 82S (2016) S1–S142
Results: HIV: Using a limit of quantification (LOQ) of 30
copies/ml (cp/ml) for Aptima assay, 67 specimens (1.62–6.47 log)
gave quantifiable results for both assays and the Deming regression
was excellent between the 2 assays: y = 1.12x− 0.59, R2 = 0.954. 58
samples gave target not detected (TND) results for both. 66 results
were discrepant at very low viral load between the 2 tests. The
overall percentage of agreement was 73.3%.
- Mean difference between measured and expected values
was <0.16 log cp/ml for the Qnostic positive control and
<0.37 log cp/ml for serial dilution of Bio Qcontrol P0043HIV-RNA
(5.40–1.70 log) tested in triplicate.
- Sensitivity assessed with serial dilution of S1003 HIV-RNA
DOM 04-20047 panel was 6.25 cp/ml for 100% of 10 replicates.
3.125 cp/ml was found to be positive in 4 out of 10.
HBV: Using a LOQ of 10 IU/ml for Aptima, 132 samples gave a
quantifiable result for both tests and the Deming regression was
excellent between the 2 assays: y = 0.95x− 0.07, R2 = 0.945. The
overall percentage of agreement was 90%.
- Excellent reproducibility was observed with BioQcontrol with
standard deviation (SD) ranging from 0.13 log at inputs below
50 IU/ml to 0.06 at inputs above 10,000 IU/ml. Results of Qnos-
tic panels were identical to results obtained at others sites using
same panels.
- Sensitivity determined with serial dilution of BioQcontrol panel
was 1.56 IU/ml for 100% of 10 replicates.
No cross contamination (neither with HIV nor with HBV) was
observed when testing 5 consecutive runs using negative control
and High positive control samples alternately.
Conclusions: The Hologic Aptima® HIV-1 Quant Dx assay and
Aptima® HBV Quant assay as performed on the fully automated
Panther system gave highly comparable performance to that of
Roche COBAS® TaqMan® HIV-1 v2 and HBV v2.0 assays for clini-
cal samples. Excellent results were observed using commercially
available panels indicating high sensitivity and very good repro-
ducibility.
This system, using 0.5ml sample input on primary samples, was
easy to use and could generate 120 test results in less than four
hours.
Abstract no: 232
Presentation at ESCV 2016: Poster 31
Nucleic acid testing of blood donors – Ege
University Hospital short term experience
Rüc¸ han Yazan Sertöz ∗ ervet Uluer Bic¸ ero˘glu
Münevver Kayın , Ays¸ ın Zeytino˘glu ,
˙Imre Altu˘glu da Erensoy
1 Ege University Medical Faculty Department of
Microbiology, ˙Izmir Turkey
2 Ege University Medical Faculty Blood Bank, ˙Izmir
Turkey
Nucleic acid testing (NAT) of donated blood prior to transfu-
sion is intended to ensure that recipients receive the safest possible
blood and blood products. Beginning in 1999, blood banks imple-
mented NAT for detection of viral nucleic acids in donated blood. It
is first conducted for HCV, HIV in 2003. Since 2009, blood centers
have replaced the dual assay for HIV and HCV nucleic acids with
a triplex assay that detects the nucleic acids of HBV in addition to
HIV and HCV.
Ege University Hospital started NAT since October 2015. During
the study period, a total of 17,328 donor samples were screened for
serological and molecular markers of HBV, HCV and HIV. Serologi-
cal screening of was performed using the Architect system (Abbott
Diagnostics, Wiesbaden, Germany) (HBsAg, anti-HCV, anti-HIV I/II).
Initially reactive samples were tested in duplicate using the same
assay. Initial reactive blood and blood products are not used even
though duplicate tests were negative. HBeAg, anti-HBc IgM, anti-
HBc, anti-HBe, anti-HBs were also tested in HBsAg negative, HBV
NAT positive bloods using the Architect system(Abbott Diagnostics,
Wiesbaden, Germany).
Molecular screening was performed using the Roche Cobas
TaqScreenMPX v2 assay (RocheMolecular Systems, NJ, USA) on the
Cobas s201 system. TheMPX v2 assay is a qualitative viral multiplex
test that simultaneously detects and discriminates between HBV-
DNA, HCV-RNA and HIV-RNA (along with an internal control) in a
single assay. Donations were screened in mini-pools of six. Mini-
pool stage testing yielded either reactive or non-reactive results,
but did not identify the individual infected donation(s). Reactive
pool were re-tested individually to identify the agent HBV, HCV
and/or HIV. Subsequent confirmatory testingwas performed on the
Abbott m2000sp and m2000rt (Abbott Molecular Diagnostics, USA)
for the confirmation of HBV-DNA, HCV-RNA and HIV-RNA targets.
During the study period 256 donors were excluded from the
study because of positive serological tests. Serological test negative
17,072 donor samples included in the NAT study. 21 pools were
positive but seven of them were negative individually. HBV-DNA
was confirmed with individual NAT in the remaining 14 positive
pools. Twelve were anti-HBc alone, three were anti-HBc reactive
together with anti-HBs and one anti-HBe together with anti-HBc.
Anti-HBs values were 62, 137, 120 IU/mL. Just two samples were
positive with the subsequent confirmatory test with Abbott. Their
viral loads were 37 and 20 IU/mL. 14/17072 (0.08%) HBV positivity
was evaluated as occult HBV.
The number of positivity is high in terms of medium endemic
hepatitis B infection in Turkey. Unconfirmed positive pools remain
as a problem. Hemovigilance, alternative more sensitive methods
as a confirmatory test may solve unconfirmed positive pools prob-
lem.
That is for sure that NAT is reducing transfusion transmitted
infections. Cost effectiveness and other algorithms may be dis-
cussed when the data accumulated.
Abstract no: 234
Presentation at ESCV 2016: Poster 32
Qualitative detection of Zika virus RNA with the
Sentosa® SA ZIKV RT-PCR test
S.K. Tan ∗, A. Soh, R. Luo, C. Lee, W. Huang,
G. Michel
Vela Research Pte Ltd., Singapore
Introduction: Zika virus (ZIKV) is an Aedes mosquito-borne
flavivirus that is transmitted to humans primarily through the
bite of an infected mosquito. Notably, infection with ZIKV dur-
ing pregnancy has been associated with fetal microcephaly and
other severe birth defects as reported from Brazil in early 2015.
As nucleic acid amplification technology (NAT)-based and sero-
logical assays were not readily available, the emergency response
to public health threat warrants the development of diagnostics
for ZIKV. The Sentosa® SA ZIKV RT-PCR Test is a real-time RT-PCR