Journal of Clinical Virology - Volume 82 - Supplement 1

Abstracts / Journal of Clinical Virology 82S (2016) S1–S142

S27

of inflammatory bowel disease, multiple sclerosis) or in screening

for latent infection in pre-transplant patients. Our hospital has a

large population of transplant patients and it seems that the sav-

ings resulting from only 3.9% of the anti-EBNA-1 tests do not justify

the loss of information.

With the anti-EBNA approach, reactivity both to EBNA-1 and

VCA IgM (4.43% of all cases) would be classified as past infection

but, in a few patients, it could in fact be a reactivation pattern.

Reactivation is of no clinical relevance in immunocompetent sub-

jects but can cause serious complications in immunocompromised

patients. In our population, immunocompromised patients (mainly

infected with HIV and transplant patients) account for 13.6% of the

total ammount. Therefore the use of anti-EBNA algorithm in gen-

eral and the use of the full panel in immunocompromised patients

would allow reducing by 82.1% the number of anti-VCA IgM and

IgG tests.

Conclusion:

The use of the anti-EBNA antibodies approach

is acceptable with regard to primary infection diagnosis. Full

panel must be used with immunocompromised patients, when

reactivation is suspected. This strategy will reduce by 82.1% the

number of IgM anti-VCA IgG tests without relevant clinical costs.

http://dx.doi.org/10.1016/j.jcv.2016.08.051

Abstract no: 133

Presentation at ESCV 2016: Poster 12

Evaluation of the Veris MDx

system for

quantification of Hepatitis B DNA and Hepatitis

C and HIV-1 RNA in a medium sized University

Hospital

Kerstin Malm

∗

, Sören Andersson,

Martin Sundqvist

Faculty of Medicine and Health, Department of

Laboratory Medicine, Örebro University, Örebro,

Sweden

Introduction:

In the diagnosis and treatment of Hepatitis B

(HBV), Hepatitis C (HCV) and HIV, it is crucial to detect and quantify

viral nucleic acid. Patients on therapy are monitored continuously

to out-rule relapses or reinfections (HCV) while for patients with

HIV these tests are important to early on detect potential break-

throughs due to resistance development. Quantification methods

are today more standardized and fast but still with no opportunity

to analyze the samples with full random access. Recently the VERIS

MDx

platform from Beckman Coulter with this possibility was

launched.

Objectives:

To evaluate a new, randomaccess laboratory instru-

ment for the simultaneous detection and quantification of HBV,

HCV and HIV-1.

Methods:

WHO standards for HBV-DNA, HCV-RNA and HIV-1-

RNA provided from the National Institute for Biological Standards

and Control (NIBSC) were diluted down to the designated low-

est level of detection and analyzed in triplicates on the Veris

MDx

(Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea, CA U.S.A.)

instrument. Plasma samples from routine laboratory testing were

analyzed and compared to the routine methods used at our hospi-

tal or the referral hospital, for HBV; COBAS

AmpliPrep/COBAS

TaqMan

HBV Test, v2.0 (Roche Molecular Diagnostics, 4300

Hacienda Drive, Pleasanton, CA, USA) (Karolinska University Hos-

pital Huddinge), for HCV; COBAS

TaqMan

HCV Test v2.0 for use

with the High Pure System (Roche) (Örebro) and for HIV; Aptima

HIV-1 Quant Dx Assay (Hologic Inc. 250 Campus Drive Marlbor-

ough, MA, USA) (Örebro). 55 samples for HBV, 120 samples for HCV

and 60 samples for HIV have been analyzed so far. The absolute

majority of samples for HCV andHIV analysis were frompatients on

treatment. All viral load data were analyzed as log10-transformed

values.

Results:

The Veris MDx

showed good compatibility to the

designated quantities of the WHO standards (except for HIV-1

where a slight over-quantification could be observed for dilutions

in the higher range, i.e. >1000 copies/mL). The limits of detection

assigned by the manufacturer could be confirmed. In clinical sam-

ples the Veris MDx

showed similar results to the comparators

with a correlation for quantifiable samples of 0.94 (HBV), 0.98 (HCV)

and 0.98 (HIV). The Veris MDx

showed a slightly higher sensi-

tivity though as DNA/RNA was detected in 4 samples for HBV, 8

for HCV and 7 for HIV when the comparator method did not. The

opposite was seen in 0, 0 and 6 samples respectively.

Conclusion:

The Veris MDx

for quantitative analysis of HBV,

HCVandHIVnucleic acids showed good correlation to the compara-

tor methods used in this study with a tendency of higher sensitivity

for the detection of HBV and HCV. The Instrument provides an

easy, fast and flexible method for quantification of RNA and DNA in

plasma samples.

http://dx.doi.org/10.1016/j.jcv.2016.08.052

Abstract no: 135

Presentation at ESCV 2016: Poster 13

Comparison of standardised and

non-standardised serology assays for clinical

virology diseases

David Padley

∗

, Francis Phimister, Josh Duran,

Rob Anderson, Neil Almond

Division of Virology, National Institute of Biological

Standards & Control, South Mimms, Herts EN6 3QG,

Serological assays are the bed rock of clinical virological diseases

as they are relatively inexpensive, quick and lend themselves to

automation. However standardisation of these diagnostic assays is

incomplete as there are relatively few International Standards for

clinical virology targets. Whilst we await their development how

standardisation can be improved?

The Quality Control Reagents Unit (QCRU), now based at NIBSC

has been producing quality control reagents for use in clinical virol-

ogy testing for nearly 20 years. These QC reagents assure the quality

of assays by acting as an external run control, by establishing amean

value for an assay with the reagent and then attaining this value

for every assay within 2-3 standard deviations (SD) of the mean.

QCRU test every batch of reagent on multiple kits and platforms,

to ensure its suitability. These data allow the unit to compare the

performance of a common reagent on multiple platforms. We have

analysed data from three types of reagent. One where an IS exists

already and 2 where development is awaited.

Analysis of data using the QCRU Rubella reagents indicate that

there can be up to 2 fold variation in the reported amount of anti-

Rubella antibody in the same sample. Interestingly there appeared

to be less variability (<60%) closer to the cut-off of the assays

than at higher concentrations. A similar variability in reporting

was observed using the anti-HCV reagent on 3 different platforms

where results were provided as OD/CO. The greatest variability in

results reportingwas observed in the reporting of anti-Mumps anti-

bodies, where different assay platforms use different units and the

figures varied between 1.2 S/CO on one platform to 728.6 EU/ml

from another.

Effective comparison between antibody data generated for the

same analyte on different diagnostic platforms is essential if clini-